Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupu... | NCT02847598 | Trialant
NCT02847598
Sponsor
Biogen
Status
Completed
Last Update Posted
Nov 7, 2023Actual
Enrollment
264Actual
Phase
Phase 2
Conditions
Systemic Lupus Erythematosus
Active Cutaneous Lupus Erythematosus
Interventions
BIIB059 (litifilimab)
Placebo
Countries
United States
Argentina
Bulgaria
Colombia
Israel
Mexico
Philippines
Poland
Serbia
South Korea
Taiwan
Thailand
Protocol Section
Identification Module
NCT ID
NCT02847598
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
230LE201
Secondary IDs
ID
Type
Description
Link
2015-004359-32
EudraCT Number
Brief Title
Study to Evaluate BIIB059 (Litifilimab) in Cutaneous Lupus Erythematosus (CLE) With or Without Systemic Lupus Erythematosus (SLE)
Official Title
A 2-Part Phase 2 Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of BIIB059 in Subjects With Systemic Lupus Erythematosus and Active Skin Manifestations and in Subjects With Active Cutaneous Lupus Erythematosus With or Without Systemic Manifestations
Acronym
LILAC
Organization
BiogenINDUSTRY
Status Module
Record Verification Date
Oct 2023
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Oct 20, 2016Actual
Primary Completion Date
Aug 28, 2019Actual
Completion Date
Nov 18, 2019Actual
First Submitted Date
Jun 6, 2016
First Submission Date that Met QC Criteria
Jul 25, 2016
First Posted Date
Jul 28, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Aug 26, 2022
Results First Submitted that Met QC Criteria
Apr 13, 2023
Results First Posted Date
May 15, 2023Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Aug 27, 2020
Certification/Extension First Submitted that Passed QC Review
Aug 27, 2020
Certification/Extension First Posted Date
Sep 2, 2020Actual
Last Update Submitted Date
Oct 25, 2023
Last Update Posted Date
Nov 7, 2023Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
BiogenINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Yes
Is FDA Regulated Device
No
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Yes
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The primary purpose of the study is to evaluate the efficacy of BIIB059 (litifilimab) in reducing disease activity in participants with systemic lupus erythematosus (SLE) with active cutaneous manifestations and joint involvement (Part A), and in participants with active cutaneous lupus erythematosus (CLE) (Subacute cutaneous lupus erythematosus (SCLE) or chronic CLE, including discoid lupus erythematosus (DLE)) with or without systemic manifestations (Part B). The secondary objective is to evaluate additional efficacy parameters of BIIB059 in reducing SLE/CLE disease activity, pharmacokinetic parameters, safety and tolerability of BIIB059 (Parts A and B).
BIIB059 450 mg administered SC, Q4W with an additional dose at Week 2 for a total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with SLE with active skin manifestations and joint involvement.
Drug: BIIB059 (litifilimab)
Part A: Placebo
Placebo Comparator
BIIB059 matching placebo administered SC, Q4W with an additional dose at Week 2 for total of 7 doses (Weeks 0, 2, 4, 8, 12, 16, and 20) in participants with SLE with active skin manifestations and joint involvement.
Drug: Placebo
Part B: BIIB059 50 mg
Experimental
BIIB059 50 mg administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.
Drug: BIIB059 (litifilimab)
Part B: BIIB059 150 mg
Experimental
BIIB059 150 mg administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.
Drug: BIIB059 (litifilimab)
Part B: BIIB059 450 mg
Experimental
Interventions
Name
Type
Description
Arm Group Labels
Other Names
BIIB059 (litifilimab)
Drug
Administered as specified in the treatment arm.
Part A: BIIB059 450 mg
Part B: BIIB059 150 mg
Part B: BIIB059 450 mg
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24
An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
Baseline to Week 24
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Baseline to Week 16
Secondary Outcomes
Measure
Description
Time Frame
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Key Inclusion Criteria:
Part A:
Diagnosis of systemic lupus erythematosus (SLE) fulfilling at least 4 out of 11 of the 1997 revised American College of Rheumatology (ACR) classification criteria for SLE along with active skin manifestations and joint involvement.
At least 4 tender joints and at least 4 swollen joints with at least 4 of the swollen joints in the proximal interphalangeal (PIP) joints, metacarpophalangeal (MCP) joints and/or wrist.
Demonstrate at least one sign of active lupus skin disease, including acute cutaneous lupus erythematosus (ACLE), subacute cutaneous lupus erythematosus (SCLE), and/or chronic cutaneous lupus erythematosus (CCLE) (e.g., discoid lupus erythematosus (DLE)), with skin activity defined by SLE Disease Activity Index 2000 (SLEDAI-2K) at the time of Screening and randomization.
Part B:
1. Active skin manifestations Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) ≥8)) and a diagnosis of cutaneous lupus erythematosus (CLE) that has been histologically confirmed (in the past or at Screening), with or without SLE manifestations.
Key Exclusion Criteria:
Active lupus nephritis or moderate-to-severe or chronic kidney disease.
Any active skin conditions other than CLE that may interfere with the study (e.g., psoriasis, non-LE skin lupus, drug-induced lupus).
History of chronic, recurrent (3 or more of the same type of infection in a 12-month period), or recent serious infection (e.g., pneumonia, septicemia, herpes zoster) as determined by the Investigator and requiring anti-infective treatment within 12 weeks prior to Screening.
Use of immunosuppressive or disease-modifying treatments for SLE or CLE that were initiated less than 12 weeks prior to Randomization.
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply
Furie RA, van Vollenhoven RF, Kalunian K, Navarra S, Romero-Diaz J, Werth VP, Huang X, Clark G, Carroll H, Meyers A, Musselli C, Barbey C, Franchimont N; LILAC Trial Investigators. Trial of Anti-BDCA2 Antibody Litifilimab for Systemic Lupus Erythematosus. N Engl J Med. 2022 Sep 8;387(10):894-904. doi: 10.1056/NEJMoa2118025.
See Also Links
Not provided
Available IPD Information
Not provided
IPD Sharing Statement Module
No data available
No data is available for this block.
Results Section
Participant Flow Module
Pre-assignment Details
A total of 264 participants were enrolled in the study. The study had two parts, Part A (participants with Systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement) and Part B (participants with active cutaneous lupus erythematosus (CLE), including discoid lupus erythematosus (DLE), with or without SLE).
Recruitment Details
Participants were enrolled at 129 investigative sites in Argentina, Bulgaria, Colombia, Israel, Korea, Mexico, Philippines, Poland, Serbia, Taiwan, Thailand, and the United States from October 20, 2016 to November 18, 2019.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Part A: Placebo
Participants with systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
FG001
Periods
Title
Milestones
Reasons Not Completed
Overall Study
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Mar 15, 2019
Aug 26, 2022
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
No data available
No data is available for this block.
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
BIIB059 450 mg administered, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.
Drug: BIIB059 (litifilimab)
Part B: Placebo
Placebo Comparator
BIIB059 matching placebo administered SC, Q4W with an additional loading dose at Week 2 for a total of 5 doses (Weeks 0, 2, 4, 8, and 12) in participants with active CLE with or without systemic manifestations.
Drug: Placebo
Part B: BIIB059 50 mg
litifilimab
Placebo
Drug
Administered as specified in the treatment arm.
Part A: Placebo
Part B: Placebo
Week 24
Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Week 12, Week 16
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Baseline, Week 12, 16 and 24
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
Baseline, Week 12
Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=4-point reduction from baseline in CLASI-A score are reported here.
Week 24
Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=4-point reduction from baseline in CLASI-A score are reported here.
Week 12, Week 16
Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=7-point reduction from baseline in CLASI-A score are reported here.
Week 24
Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=7-point reduction from baseline in CLASI-A score are reported here.
Week 12, Week 16
Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24
An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a <1-point increase in the PGA (VAS) [on a scale of 0 to 10],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported.
Week 24
Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24
The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores representing increased disease activity.
Baseline to Week 24
Part A: Percentage of Participants With no New Organ System Affected at Week 24
No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
Week 24
Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24
The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity.
Baseline to Week 24
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Baseline up to Week 36
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Baseline up to Week 28
Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Baseline up to Week 36
Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Baseline up to Week 28
Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities
Baseline up to Week 36
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
Baseline up to Week 28
Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
Baseline up to Week 36
Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
Baseline up to Week 28
Part A: Number of Participants With Positive BIIB059 Antibodies
Baseline up to Week 24
Part B: Number of Participants With Positive BIIB059 Antibodies
Baseline up to Week 16
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels
Baseline up to Week 24
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels
Baseline up to Week 16
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.
Baseline to Week 24
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.
Baseline to Week 12
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24
Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).
Baseline to Week 24
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12
Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.
Baseline to Week 12
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels
Baseline up to Week 24
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels
Baseline up to Week 16
Part A: Percent Change From Baseline in Vaccine Titers at Week 24
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody
Baseline to Week 24
Part B: Percent Change From Baseline in Vaccine Titers at Week 12
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.
Baseline to Week 12
Part A: Serum Concentration of BIIB059
Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253
Part B: Serum Concentration of BIIB059
Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197
Phoenix
Arizona
85037
United States
University of Arkansas for Medical Sciences
Little Rock
Arkansas
72205
United States
TriWest Research Associates, LLC
El Cajon
California
92020
United States
Tien Q Nguyen MD Inc
Fountain Valley
California
92708
United States
MD Med Corp
Hemet
California
92543
United States
Universtiy of California, Irvine
Irvine
California
92697
United States
The Regents of the University of California
La Jolla
California
92037
United States
Purushotham Akther & Rosan Kotha, MD Inc.
La Mesa
California
92120
United States
Dermatology Reserach Associates
Los Angeles
California
90045
United States
University Clinical Trials
San Diego
California
92123
United States
Richard Barthel, MD
Santa Barbara
California
93108
United States
Robin K. Dore, MD, Inc.
Tustin
California
92780
United States
Inland Rheumatology Clinical Trials Inc.
Upland
California
91786
United States
Nazanin Firooz, MD Inc.
West Hills
California
91307
United States
Denver Arthritis Clinic
Denver
Colorado
80230
United States
Medical Faculty Associates, Inc.
Washington D.C.
District of Columbia
20037
United States
Howard University Hospital
Washington D.C.
District of Columbia
20060
United States
Washington DC VA Medical Center
Washington D.C.
District of Columbia
20422
United States
Clinical Research of West Florida- Corporate
Clearwater
Florida
33765
United States
Medical Research Center Of Miami
Miami
Florida
33144
United States
Lakes Research, LLC
Miami Lakes
Florida
33014
United States
Omega Research Consultants
Orlando
Florida
32804
United States
Compass Research, LLC
Orlando
Florida
32806
United States
DMI Research, Inc.
Pinellas Park
Florida
33710
United States
Advanced Medical Reserarch, PC
Sandy Springs
Georgia
30328
United States
Advanced Clinical Research
Boise
Idaho
83642
United States
Dawes Fretzin Clinical Research Group, LLC
Indianapolis
Indiana
46256
United States
Brigham and Women's Hospital
Boston
Massachusetts
02115
United States
University of Michigan
Ann Arbor
Michigan
48109
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Davis Group, LTD
Las Vegas
Nevada
89128
United States
Valley Hospital
Ridgewood
New Jersey
07450
United States
Institute for Rheumatic & Autoimmune diseases, Overlook Medical Center
Hartmann S, Biliouris K, Naik H, Rabah D, Stevenson L, Shen C, Nestorov IA, Lesko LJ, Trame MN. A clinical population pharmacokinetic/pharmacodynamic model for BIIB059, a monoclonal antibody for the treatment of systemic and cutaneous lupus erythematosus. J Pharmacokinet Pharmacodyn. 2020 Jun;47(3):255-266. doi: 10.1007/s10928-020-09688-y. Epub 2020 Apr 25.
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
FG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
FG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
FG004
Part B: Placebo
Participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
FG005
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
FG006
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
FG007
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
FG00056 subjects
FG0016 subjects
FG0026 subjects
FG00364 subjects
FG00433 subjects
FG00526 subjects
FG00625 subjects
FG00748 subjects
COMPLETED
FG00051 subjects
FG0016 subjects
FG0026 subjects
FG00360 subjects
FG00430 subjects
FG00523 subjects
FG00623 subjects
FG00744 subjects
NOT COMPLETED
FG0005 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG0043 subjects
FG0053 subjects
FG0062 subjects
FG0074 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0071 subjects
Consent withdrawn
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0034 subjects
FG004
Death
FG0003 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Modified intent-to-treat (MITT) population included all randomized participants who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Part A: Placebo
Participants with systemic lupus erythematosus (SLE) with active skin manifestations and joint involvement received BIIB059 matching placebo subcutaneously (SC) every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
BG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
BG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
BG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
BG004
Part B: Placebo
Participants with active cutaneous lupus erythematosus (CLE) with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
BG005
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
BG006
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
BG007
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
BG008
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00056
BG0016
BG0026
BG00364
BG00433
BG00526
BG00625
BG00748
BG008264
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00041.4± 12.2
BG00135.0± 14.4
BG00240.8± 13.4
BG003
Sex: Female, Male
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Female
BG00049
BG0016
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00025
BG0011
BG002
Race (NIH/OMB)
Count of Participants
Participants
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0008
BG0010
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Part A: Change From Baseline in Active Joint Count (28-joint Assessment) to Week 24
An active joint is defined as a joint with pain and signs of inflammation (e.g., tenderness, swelling or effusion). The 28 Joint Count includes assessment of swelling and tenderness in the shoulders, elbows, wrists, metacarpophalangeal joints, proximal interphalangeal joints and knees. The investigator counts how many of the 28 joints are swollen or tender at the given week.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Deviation
joints
Baseline to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00041
OG0012
OG0021
OG003
Title
Denominators
Categories
Title
Measurements
OG000-12.7± 10.3
OG001-9.0± 5.7
OG002-13.0± NASince only 1 participant was analyzed, standard deviation (SD) was not evaluated.
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
A Mixed Effect Model Repeat Measurement (MMRM) model is performed, using treatment group, study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
MMRM
0.037
Least squares (LS) mean Difference
-3.4
2-Sided
95
-6.7
-0.2
Superiority
Primary
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score to Week 16
The Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) is a clinical tool that quantifies disease activity and damage in cutaneous lupus erythematosus (CLE). The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline to Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Secondary
Part A : Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 24
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Week 24. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies those with baseline CLASI-A >=8 following protocol amendment.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Secondary
Part B: Percentage of Participants With Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity- 50 (CLASI-50) Response at Week 12 and 16
CLASI-50 Response is defined as a 50% improvement from baseline in CLASI-A score at Weeks 12 and 16. The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Number
percentage of participants
Week 12, Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Secondary
Part A: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12, 16 and 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12, 16 and 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Secondary
Part B: Percent Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity.
MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participant analyzed in this outcome measure.
Posted
Mean
Standard Deviation
percent change
Baseline, Week 12
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Secondary
Part A: Percentage of Participants With a >=4-point Reduction From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=4-point reduction from baseline in CLASI-A score are reported here.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Secondary
Part B: Percentage of Participants With a >=4-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=4-point reduction from baseline in CLASI-A score are reported here.
MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Number
percentage of participants
Week 12, Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Secondary
Part A: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 24
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=7-point reduction from baseline in CLASI-A score are reported here.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Secondary
Part B: Percentage of Participants With a >=7-point Change From Baseline in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 12 and 16
The CLASI is a clinical tool that quantifies disease activity and damage in CLE. The activity scale (CLASI-A) includes measurements of erythema, scale and hypertrophy, and mucous membrane disease. Each part of the body is listed separately, from the scalp to the feet, in addition to sections focusing on mucous membrane involvement and alopecia. Points are given for the presence of erythema, scale, mucous membrane lesions, recent hair loss, and inflammatory alopecia. Composite scores are calculated by summing the individual component scores. CLASI-A scores of 0-9, 10-20, and 21-70 represent disease severity of mild, moderate, and severe, respectively. Higher scores indicate more disease activity. The percentage of participants with a >=7-point reduction from baseline in CLASI-A score are reported here.
MITT population included all randomized participants in Part B who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Number
percentage of participants
Week 12, Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Secondary
Part A: Percentage of Participants Achieving a Systemic Lupus Erythematosus (SLE) Responder Index >=4 (SRI-4) at Week 24
An SRI-4 at Week 24 was a categorical response variable (Yes/No) incorporating the following criteria for achievement of responder status (i.e., all criteria must have been met to achieve responder status): A reduction from baseline of ≥4 points in SLEDAI-2K, No new organ system affected, as defined by no new BILAG-2004 Grade A and no more than 1 new BILAG-2004 Grade B, No worsening from baseline in participant's lupus disease activity, defined by a <1-point increase in the PGA (VAS) [on a scale of 0 to 10],No changes to protocol-specified medication rules,as follows (all criteria were required to be met): No initiation or increase of SLE standard of care therapy or other disallowed concomitant therapy; Concomitant corticosteroid dosage at Week 24 to be ≤10 mg/day;Concomitant corticosteroid dosage at Week 24 was no more than at Day 1;No increase in corticosteroid dose between Weeks 17 and 24. The percentage of participants who had responded to each of the 4 criteria was also reported.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
Secondary
Part A: Change From Baseline in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) Score at Week 24
The SLEDAI-2K is a reliable, valid, simple, 1-page activity index that measures disease activity and records features of active lupus as present or not. It uses a weighted checklist to assign a numeric score based on the presence or absence of 24 symptoms at the time of assessment or during the previous 28 days. Each symptom present is assigned between 1 and up to 8 points based on its usual clinical importance, yielding a total score that ranges from 0 points (no symptoms) to 105 points (presence of all defined symptoms), where higher scores representing increased disease activity.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
Baseline to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
Secondary
Part A: Percentage of Participants With no New Organ System Affected at Week 24
No new organ system affected, as defined by no new British Isles Lupus Activity Group (BILAG)-2004 A and no more than one new BILAG-2004 B. The BILAG-2004 index categorizes disease activity in each organ system into five different levels from A to E. Grade A represents very active disease, Grade B represents moderate disease activity, Grade C indicates mild stable disease, and grade D implies no disease activity, but suggests the organ system had previously been affected. Grade E indicates no current or previous disease activity. A score is applied to each grade of each organ system using coding scheme of A=12, B=8, C=1, and D/E=0 and is summarized as a total score ranging 0-108. Higher scores indicate more severe disease activity.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol).
Posted
Number
percentage of participants
Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
Secondary
Part A: Change From Baseline in Physician's Global Assessment (PGA) of SLE Visual Analog Scale (VAS) Score at Week 24
The PGA is used to quantify disease activity and is measured using an anchored VAS. The PGA asks the Investigator to assess the participants current disease activity from a score of 0 (none) to 3 (severe), where higher score means severe SLE disease activity.
MITT population included all randomized participants in Part A who had received at least 1 dose of study treatment (whether or not the participants adhered to the protocol). Here, "number of participants analyzed" signifies number of participants analyzed in this outcome measure.
Posted
Mean
Standard Deviation
score on a scale
Baseline to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Secondary
Part A: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 36
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
Secondary
Part B: Number of Participants With Treatment Emergent Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE is any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and that does not necessarily have a causal relationship with this treatment. An SAE is any untoward medical occurrence that at any dose: Results in death; in the view of the Investigator, places the participant at immediate risk of death (a life-threatening event); however, this does not include an event that, had it occurred in a more severe form, might have caused death; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity; results in a congenital anomaly/birth defect.
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 28
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Secondary
Part A: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 36
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Secondary
Part B: Number of Participants With Clinically Significant Laboratory Assessment Abnormalities
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 28
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Secondary
Part A: Number of Participants With Clinically Significant Vital Sign Abnormalities
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 36
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Secondary
Part B: Number of Participants With Clinically Significant Vital Sign Abnormalities
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 28
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Secondary
Part A: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 36
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Secondary
Part B: Number of Participants With Clinically Significant 12-Lead Electrocardiograms (ECGs) Abnormalities
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 28
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Secondary
Part A: Number of Participants With Positive BIIB059 Antibodies
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Secondary
Part B: Number of Participants With Positive BIIB059 Antibodies
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
Posted
Count of Participants
Participants
Baseline up to Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Secondary
Part A: Absolute Change From Baseline Over Time in Immunoglobulin Levels
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
grams per Liter (g/L)
Baseline up to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Secondary
Part B: Absolute Change From Baseline Over Time in Immunoglobulin Levels
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
g/L
Baseline up to Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Secondary
Part A: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 24
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
milligrams per liter (mg/L)
Baseline to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Secondary
Part B: Absolute Change From Baseline in Vaccine Titers - Streptococcus Pneumoniae (S. Pneumoniae) at Week 12
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) were analyzed, including 23 types of serotypes (sero). AB = Antibody.
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
mg/L
Baseline to Week 12
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Secondary
Part A: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 24
Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed using international units per milliliter (IU/mL).
Safety population included all randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
IU/mL
Baseline to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Secondary
Part B: Absolute Change From Baseline in Vaccine Titers - Clostridium Tetani (C. Tetani) and Diphtheria at Week 12
Vaccine-related immunoglobulin titers for tetanus and diphtheria were analyzed.
Safety population included all randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
IU/mL
Baseline to Week 12
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Secondary
Part A: Percent Change From Baseline Over Time in Immunoglobulin Levels
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
percent change
Baseline up to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Secondary
Part B: Percent Change From Baseline Over Time in Immunoglobulin Levels
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
percent change
Baseline up to Week 16
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Secondary
Part A: Percent Change From Baseline in Vaccine Titers at Week 24
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody
Safety population included all the randomized participants in Part A who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
percent change
Baseline to Week 24
ID
Title
Description
OG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo SC every 4 weeks, starting at Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Secondary
Part B: Percent Change From Baseline in Vaccine Titers at Week 12
Vaccine-related immunoglobulin (Ig) titers for Pneumococcus (S. pneumoniae) including 23 types of serotypes (sero), tetanus and diphtheria were analyzed. AB = Antibody.
Safety population included all the randomized participants in Part B who had received at least one dose of randomized study treatment and was based on the actual treatment received. Here, "overall number of participants analyzed" signifies number of participants analyzed in this outcome measure and "number analyzed" signifies number of participants analyzed at specific timepoint.
Posted
Mean
Standard Deviation
percent change
Baseline to Week 12
ID
Title
Description
OG000
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Secondary
Part A: Serum Concentration of BIIB059
The PK population included the safety participants who had at least 1 PK concentration measurement. The number analyzed is the number of participants with data available for analysis at the specified time point. The number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Mean
Standard Deviation
nanogram per milliliter (ng/mL)
Part A: pre-dose on Days 1, 29, 85 and 113 and post-dose on Days 1, 8, 29, 85, 169, 197 and 253
ID
Title
Description
OG000
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG001
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
Secondary
Part B: Serum Concentration of BIIB059
The PK population included the safety participants who had at least 1 PK concentration measurement. Number analyzed is the number of participants with data available for analysis at the specified time point.
Posted
Mean
Standard Deviation
ng/mL
Part B: pre-dose on Days 1, 29, 85 and post-dose on Days 1, 29, 85, 113, 141, 169 and 197
ID
Title
Description
OG000
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG001
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Time Frame
Part A: up to Week 36, Part B: up to Week 28
Description
Safety population included all the randomized participants in Part A and B who had received at least one dose of randomized study treatment and was based on the actual treatment received.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Part A: Placebo
Participants with SLE with active skin manifestations and joint involvement received BIIB059 matching placebo, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
3
56
6
56
22
56
EG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
0
6
0
6
3
6
EG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
0
6
1
6
6
6
EG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
0
64
3
64
22
64
EG004
Part B: Placebo
Participants with active CLE with or without systemic manifestations received BIIB059 matching placebo administered SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
0
33
3
33
19
33
EG005
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
0
26
1
26
16
26
EG006
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
0
25
3
25
10
25
EG007
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
0
48
3
48
28
48
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Myocardial infarction
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG0030 affected64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0070 affected48 at risk
Supraventricular tachycardia
Cardiac disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Retinal artery thrombosis
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Visual impairment
Eye disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ileus
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Incarcerated umbilical hernia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Intestinal obstruction
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Intestinal perforation
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypersensitivity
Immune system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Gastroenteritis bacterial
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Parasitic gastroenteritis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Systemic viral infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Muscular weakness
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Skin angiosarcoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Ataxia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cerebrovascular disorder
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Epilepsy
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Migraine
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Paraesthesia
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pulmonary embolism
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Diarrhoea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0003 affected56 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG0033 affected64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
Nausea
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Asthenia
General disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Fatigue
General disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Injection site erythema
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected56 at risk
EG0010 affected6 at risk
EG0022 affected6 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected56 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0006 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0004 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pain in extremity
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Systemic lupus erythematosus
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0008 affected56 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pruritus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0002 affected56 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Neutrophilia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Spigelian hernia
Gastrointestinal disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Injection site warmth
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0002 affected56 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Rhinitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected6 at risk
EG0021 affected6 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Repetitive strain injury
Injury, poisoning and procedural complications
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Neutrophil count increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Tension headache
Nervous system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Ecchymosis
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Purpura
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0001 affected56 at risk
EG0010 affected6 at risk
EG0021 affected6 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0011 affected6 at risk
EG0020 affected6 at risk
EG003
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Injection site pruritus
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Injection site rash
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Pyrexia
General disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Transaminases increased
Investigations
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Cutaneous lupus erythematosus
Skin and subcutaneous tissue disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.1
Systematic Assessment
EG0000 affected56 at risk
EG0010 affected6 at risk
EG0020 affected6 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
OTHER
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Our agreement is subject to confidentiality but generally the PI can publish, for noncommercial purposes only, results and methods of the trial, but no other Sponsor Confidential Information. PI must give Sponsor no less than 60 days to review any manuscript for a proposed publication and must delay publication for up to an additional 90 days thereafter if Sponsor needs to file any patent application to protect any of Sponsor's intellectual property contained in the proposed publication.
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00031
OG00123
OG00224
OG00342
Title
Denominators
Categories
Title
Measurements
OG000-15.03± 37.23
OG001-35.52± 33.35
OG002-47.11± 34.10
OG003-41.66± 37.33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
MMRM
0.015
LS mean difference
-24.29
2-Sided
95
-43.70
-4.88
Superiority
OG000
OG002
A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
MMRM
<0.001
LS mean difference
-33.42
2-Sided
95
-52.71
-14.12
Superiority
OG000
OG003
A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
MMRM
0.001
LS mean difference
-27.99
2-Sided
95
-44.55
-11.42
Superiority
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00038
OG0016
OG0026
OG00339
Title
Denominators
Categories
Title
Measurements
OG00042.11
OG00150
OG00216.67
OG00364.10
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Week 12
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00348
Title
Measurements
OG00012.12
OG00138.46
OG00248.00
OG003
Week 16
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00343
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00038
OG0016
OG0026
OG00339
Title
Denominators
Categories
Change at Week 12
ParticipantsOG00037
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00338
Title
Measurements
OG000-36.63± 28.23
OG001-29.32± 14.66
OG002-8.39± 34.48
OG003
Change at Week 16
ParticipantsOG00035
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00338
Change at Week 24
ParticipantsOG00035
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00335
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
Week 12: A MMRM model is performed, using treatment group study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
MMRM
0.220
LS Mean Difference
-9.93
2-Sided
95
-25.94
6.08
Superiority
OG000
OG003
Week 16: A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
MMRM
0.293
LS Mean Difference
-8.96
2-Sided
95
-25.82
7.90
Superiority
OG000
OG003
Week 24: A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
MMRM
0.062
LS Mean Difference
-15.74
2-Sided
95
-32.28
0.79
Superiority
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00032
OG00123
OG00224
OG00344
Title
Denominators
Categories
Title
Measurements
OG000-10.73± 34.41
OG001-38.72± 32.99
OG002-47.82± 31.80
OG003-35.25± 35.77
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
MMRM
0.001
LS mean difference
-30.36
2-Sided
95
-48.75
-11.97
Superiority
OG000
OG002
A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
MMRM
<0.001
LS mean difference
-37.17
2-Sided
95
-55.46
-18.87
Superiority
OG000
OG003
A MMRM model is performed, using treatment group, study visit, study visit-by-treatment interaction, DLE (Yes/No), CLASI-A score (<=10 vs. >10) as fixed effect covariates.
MMRM
0.001
LS mean difference
-26.05
2-Sided
95
-41.71
-10.40
Superiority
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00038
OG0016
OG0026
OG00339
Title
Denominators
Categories
Title
Measurements
OG00057.89
OG00183.66
OG00216.67
OG00371.79
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Week 12
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00348
Title
Measurements
OG00033.33
OG00150.00
OG00276.00
OG003
Week 16
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00343
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00038
OG0016
OG0026
OG00339
Title
Denominators
Categories
Title
Measurements
OG00034.21
OG00166.67
OG00216.67
OG00356.41
Part B: BIIB059 50 mg
Participants with active CLE with or without systemic manifestations received BIIB059 50 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Week 12
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00348
Title
Measurements
OG00018.18
OG00138.46
OG00240.00
OG003
Week 16
ParticipantsOG00032
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00343
OG001
Part A: BIIB059 50 mg
Participants with SLE with active skin manifestations received BIIB059 50 mg (milligrams), SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
Title
Measurements
OG00028.57
OG00133.33
OG00216.67
OG00356.25
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00050
OG0016
OG0023
OG00359
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 3.3
OG001-3.0± 4.7
OG002-1.3± 2.4
OG003-4.4± 4.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
A MMRM model is performed, using treatment group, study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the outcome measure, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
MMRM
0.007
LS Mean Difference
-1.7
2-Sided
95
-3.0
-0.5
Superiority
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
Title
Measurements
OG00082.14
OG001100.00
OG00250.00
OG00385.94
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00049
OG0016
OG0026
OG00357
Title
Denominators
Categories
Title
Measurements
OG000-2.46± 2.13
OG001-2.05± 1.18
OG002-0.12± 1.48
OG003-2.45± 2.33
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG003
A MMRM model is performed, using treatment group (BIIB059 450 mg vs. placebo), study visit, baseline corticosteroid usage level (<=10 mg, >10 mg), region, study visit-by-treatment interaction, baseline value of the endpoint, and baseline-by-visit interaction as fixed effect covariates. Statistical analysis for placebo and BIIB059 450 mg was planned and reported.
MMRM
0.667
LS mean difference
-0.16
2-Sided
95
-0.90
0.58
Superiority
OG002
Part A: BIIB059 150 mg
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
AEs
Title
Measurements
OG00038
OG0013
OG0026
OG00336
SAEs
Title
Measurements
OG0006
OG0010
OG0021
OG003
OG002
Part B: BIIB059 150 mg
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
AEs
Title
Measurements
OG00022
OG00118
OG00215
OG00338
SAEs
Title
Measurements
OG0003
OG0011
OG0023
OG003
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0025
OG00364
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0020
OG0030
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00363
Title
Denominators
Categories
Title
Measurements
OG0001
OG0010
OG0020
OG0035
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00032
OG00126
OG00225
OG00348
Title
Denominators
Categories
Title
Measurements
OG0000
OG0015
OG0024
OG0035
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
Immunoglobulin A (IgA): Baseline
ParticipantsOG00056
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00364
Title
Measurements
OG0003.350± 1.862
OG0013.610± 0.730
OG0024.080± 1.537
OG003
IgA: Change at Week 16
ParticipantsOG00045
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00354
IgA: Change at Week 24
ParticipantsOG00052
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Immunoglobulin G (IgG): Baseline
ParticipantsOG00056
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00364
IgG: Change at Week 16
ParticipantsOG00045
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00354
IgG: Change at Week 24
ParticipantsOG00052
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Immunoglobulin M (IgM): Baseline
ParticipantsOG00056
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00364
IgM: Change at Week 16
ParticipantsOG00045
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00354
IgM: Change at Week 24
ParticipantsOG00052
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
IgA: Baseline
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00348
Title
Measurements
OG0003.341± 1.113
OG0013.873± 1.663
OG0022.900± 1.705
OG003
IgA: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
IgA: Change at Week 16
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
IgG: Baseline
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00348
IgG: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
IgG: Change at Week 16
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
IgM: Baseline
ParticipantsOG00033
ParticipantsOG00126
ParticipantsOG00225
ParticipantsOG00348
IgM: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
IgM: Change at Week 16
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00054
OG0016
OG0026
OG00363
Title
Denominators
Categories
Sero 1 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Title
Measurements
OG0002.017± 4.9787
OG0013.873± 3.8400
OG0022.705± 5.3558
OG003
Sero 1 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 2 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 2 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 3 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 3 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 4 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 4 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 5 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 5 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 6 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 6 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 7 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 7 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 8 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 8 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 9N IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 9N IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 9V IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 9V IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 10A IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 10A IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 11A IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 11A IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 12F IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 12F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 14 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 14 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 15B IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 15B IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 17F IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 17F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 18C IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 18C IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 19A IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 19A IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 19F IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 19F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 20 IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 20 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 22F IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 22F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 23F IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 23F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 33F IgG AB: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 33F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00010
OG0011
OG0020
OG00321
Title
Denominators
Categories
Sero 1 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Title
Measurements
OG0003.538± 6.0374
OG0010.210± NASince only 1 participant was analyzed, SD was not evaluated.
OG0031.930± 2.6639
Sero 1 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 2 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 2 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 3 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 3 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 4 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 4 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 5 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 5 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 6B IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 6B IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 7F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 7F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 8 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 8 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 9N IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 9N IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 9V IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 9V IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 10A IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 10A IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 11A IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 11A IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 12F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 12F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 14 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 14 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 15B IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 15B IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 17F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 17F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 18C IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 18C IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 19A IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 19A IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 19F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 19F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 20 IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 20 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 22F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 22F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 23F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 23F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 33F IgG AB: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Sero 33F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00054
OG0016
OG0026
OG00362
Title
Denominators
Categories
C. tetani IgG Antibody: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00362
Title
Measurements
OG0002.46± 2.532
OG0011.73± 1.660
OG0022.52± 2.219
OG003
C. tetani IgG Antibody: Change at Week 24
ParticipantsOG00050
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00358
Diphtheria IgG Antibody: Baseline
ParticipantsOG00054
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00362
Diphtheria IgG Antibody: Change at Week 24
ParticipantsOG00050
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00358
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00010
OG0011
OG0020
OG00321
Title
Denominators
Categories
C. tetani IgG Antibody: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Title
Measurements
OG0004.41± 3.469
OG0013.00± NASince only 1 participant was analyzed, SD was not evaluated.
OG0035.04± 2.910
C. tetani IgG Antibody: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Diphtheria IgG Antibody: Baseline
ParticipantsOG00010
ParticipantsOG0011
ParticipantsOG0020
ParticipantsOG00321
Diphtheria IgG Antibody: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00056
OG0016
OG0026
OG00364
Title
Denominators
Categories
IgA: Change at Week 16
ParticipantsOG00045
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00354
Title
Measurements
OG0001.50± 11.91
OG003-0.53± 9.22
IgA: Change at Week 24
ParticipantsOG00052
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
IgG: Change at Week 16
ParticipantsOG00045
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00354
IgG: Change at Week 24
ParticipantsOG00052
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
IgM: Change at Week 16
ParticipantsOG00045
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00354
IgM: Change at Week 24
ParticipantsOG00052
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00033
OG00126
OG00225
OG00348
Title
Denominators
Categories
Ig A: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
Title
Measurements
OG000-1.45± 7.14
OG003-5.11± 14.44
Ig A: Change at Week 16
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
Ig G: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
Ig G: Change at Week 16
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
Ig M: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
Ig M: Change at Week 16
ParticipantsOG00025
ParticipantsOG00125
ParticipantsOG00225
ParticipantsOG00330
Participants with SLE with active skin manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional dose at Week 2 for a total of 7 doses up to Week 20.
OG003
Part A: BIIB059 450 mg
Participants with SLE with active skin manifestations and joint involvement received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 7 doses up to Week 20.
Units
Counts
Participants
OG00054
OG0016
OG0026
OG00363
Title
Denominators
Categories
Sero 1 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Title
Measurements
OG00053.629± 206.5979
OG0012.996± 56.3607
OG002-10.403± 40.9969
OG003
Sero 2 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 3 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 4 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 5 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 6B IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 7F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 8 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00363
Sero 9N IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 9V IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 10A IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 11A IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 12F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 14 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 15B IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 17F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 18C IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 19A IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 19F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 20 IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 22F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00357
Sero 23F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00359
Sero 33F IgG AB: Change at Week 24
ParticipantsOG00051
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00358
C.tetani IgG Antibody: Change at Week24
ParticipantsOG00050
ParticipantsOG0016
ParticipantsOG0026
ParticipantsOG00358
Diphtheria IgG Antibody: Change at Week 24
ParticipantsOG00037
ParticipantsOG0014
ParticipantsOG0024
ParticipantsOG00344
Participants with active CLE with or without systemic manifestations received BIIB059 150 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
OG003
Part B: BIIB059 450 mg
Participants with active CLE with or without systemic manifestations received BIIB059 450 mg, SC every 4 weeks, starting Week 0 with an additional loading dose at Week 2 for a total of 5 doses up to Week 12.
Units
Counts
Participants
OG00010
OG0011
OG0020
OG00321
Title
Denominators
Categories
Sero 1 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Title
Measurements
OG00016.835± 59.1269
OG0034.257± 67.8533
Sero 2 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 3 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 4 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 5 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 6B IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 7F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 8 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 9N IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 9V IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00315
Sero 10A IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 11A IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 12F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 14 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 15B IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 17F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 18C IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 19A IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 19F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 20 IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 22F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 23F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Sero 33F IgG AB: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
C. tetani IgG Antibody: Change at Week 12
ParticipantsOG0007
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00316
Diphtheria IgG Antibody: Change at Week 12
ParticipantsOG0006
ParticipantsOG0010
ParticipantsOG0020
ParticipantsOG00314
Units
Counts
Participants
OG0006
OG0016
OG00264
Title
Denominators
Categories
Day 1: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00264
Title
Measurements
OG0000.0± 0.0
OG0010.0± 0.0
OG0020.0± 0.0
Day 1: Post-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00251
Title
Measurements
OG000
Day 8
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00262
Title
Measurements
OG000
Day 29: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00261
Title
Measurements
OG000
Day 29: Post-dose
ParticipantsOG0006
ParticipantsOG0015
ParticipantsOG00260
Title
Measurements
OG000
Day 85: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00259
Title
Measurements
OG000
Day 85: Post-dose
ParticipantsOG0000
ParticipantsOG0010
ParticipantsOG00252
Title
Measurements
OG002
Day 113: Pre-dose
ParticipantsOG0006
ParticipantsOG0016
ParticipantsOG00259
Title
Measurements
OG000
Day 169
ParticipantsOG0006
ParticipantsOG0014
ParticipantsOG00259
Title
Measurements
OG000
Day 197
ParticipantsOG0004
ParticipantsOG0014
ParticipantsOG00256
Title
Measurements
OG000
Day 253
ParticipantsOG0000
ParticipantsOG0011
ParticipantsOG00238
Title
Measurements
OG001
Units
Counts
Participants
OG00026
OG00125
OG00248
Title
Denominators
Categories
Day 1: Pre-dose
ParticipantsOG00026
ParticipantsOG00125
ParticipantsOG00247
Title
Measurements
OG0000.0± 0.1
OG0010.1± 0.2
OG0020.0± 0.1
Day 1: Post-dose
ParticipantsOG00011
ParticipantsOG00117
ParticipantsOG00241
Title
Measurements
OG000
Day 8
ParticipantsOG00026
ParticipantsOG00124
ParticipantsOG00227
Title
Measurements
OG000
Day 29: Pre-dose
ParticipantsOG00026
ParticipantsOG00124
ParticipantsOG00247
Title
Measurements
OG000
Day 29: Post-dose
ParticipantsOG00023
ParticipantsOG00124
ParticipantsOG00244
Title
Measurements
OG000
Day 85: Pre-dose
ParticipantsOG00022
ParticipantsOG00124
ParticipantsOG00229
Title
Measurements
OG000
Day 85: Post-dose
ParticipantsOG00021
ParticipantsOG00124
ParticipantsOG00229
Title
Measurements
OG000
Day 113
ParticipantsOG00022
ParticipantsOG00125
ParticipantsOG00230
Title
Measurements
OG000
Day 141
ParticipantsOG00014
ParticipantsOG00122
ParticipantsOG00244
Title
Measurements
OG000
Day 169
ParticipantsOG0004
ParticipantsOG00112
ParticipantsOG00239
Title
Measurements
OG000
Day 197
ParticipantsOG0002
ParticipantsOG0018
ParticipantsOG00235
Title
Measurements
OG000
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0050 affected26 at risk
EG0062 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0043 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0052 affected26 at risk
EG0060 affected25 at risk
EG0072 affected48 at risk
2 affected
64 at risk
EG0041 affected33 at risk
EG0053 affected26 at risk
EG0062 affected25 at risk
EG0074 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0052 affected26 at risk
EG0061 affected25 at risk
EG0072 affected48 at risk
3 affected
64 at risk
EG0042 affected33 at risk
EG0052 affected26 at risk
EG0065 affected25 at risk
EG0073 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0050 affected26 at risk
EG0062 affected25 at risk
EG0071 affected48 at risk
2 affected
64 at risk
EG0041 affected33 at risk
EG0052 affected26 at risk
EG0062 affected25 at risk
EG0072 affected48 at risk
4 affected
64 at risk
EG0040 affected33 at risk
EG0052 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
2 affected
64 at risk
EG0042 affected33 at risk
EG0051 affected26 at risk
EG0062 affected25 at risk
EG0073 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0053 affected26 at risk
EG0060 affected25 at risk
EG0071 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0043 affected33 at risk
EG0052 affected26 at risk
EG0062 affected25 at risk
EG0072 affected48 at risk
1 affected
64 at risk
EG0043 affected33 at risk
EG0056 affected26 at risk
EG0060 affected25 at risk
EG0072 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0052 affected26 at risk
EG0061 affected25 at risk
EG0072 affected48 at risk
2 affected
64 at risk
EG0041 affected33 at risk
EG0051 affected26 at risk
EG0063 affected25 at risk
EG0071 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
4 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
1 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0042 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0073 affected48 at risk
0 affected
64 at risk
EG0040 affected33 at risk
EG0050 affected26 at risk
EG0060 affected25 at risk
EG0073 affected48 at risk
0 affected
64 at risk
EG0042 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0072 affected48 at risk
0 affected
64 at risk
EG0042 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0072 affected48 at risk
0 affected
64 at risk
EG0042 affected33 at risk
EG0051 affected26 at risk
EG0060 affected25 at risk
EG0070 affected48 at risk
0 affected
64 at risk
EG0042 affected33 at risk
EG0051 affected26 at risk
EG0061 affected25 at risk
EG0072 affected48 at risk
0 affected
64 at risk
EG0044 affected33 at risk
EG0051 affected26 at risk
EG0061 affected25 at risk
EG0072 affected48 at risk
0 affected
64 at risk
EG0041 affected33 at risk
EG0050 affected26 at risk
EG0061 affected25 at risk
EG0073 affected48 at risk
37.50
Title
Measurements
OG00021.88
OG00138.46
OG00244.00
OG00346.51
-44.36
± 39.69
Title
Measurements
OG000-42.55± 32.46
OG001-41.76± 19.72
OG002-6.19± 21.31
OG003-50.20± 38.32
Title
Measurements
OG000-45.40± 34.38
OG001-58.61± 35.16
OG002-17.92± 31.16
OG003-60.59± 37.36
47.92
Title
Measurements
OG00037.50
OG00146.15
OG00272.00
OG00355.81
33.33
Title
Measurements
OG00021.88
OG00130.77
OG00248.00
OG00341.86
3
3
3.116
± 1.682
Title
Measurements
OG0000.033± 0.529
OG003-0.006± 0.305
Title
Measurements
OG000-0.093± 0.704
OG001-0.433± 1.188
OG002-0.057± 0.966
OG0030.012± 0.505
Title
Measurements
OG00014.423± 4.927
OG00115.723± 1.584
OG00217.620± 5.502
OG00314.792± 6.778
Title
Measurements
OG0001.057± 2.832
OG0030.233± 2.478
Title
Measurements
OG0000.874± 3.376
OG001-0.468± 1.333
OG002-0.790± 4.967
OG0030.758± 2.599
Title
Measurements
OG0001.046± 0.657
OG0011.065± 0.507
OG0021.242± 0.718
OG0031.106± 0.953
Title
Measurements
OG0000.004± 0.137
OG003-0.065± 0.294
Title
Measurements
OG000-0.003± 0.191
OG001-0.050± 0.113
OG002-0.150± 0.160
OG003-0.072± 0.409
3.061
± 1.413
Title
Measurements
OG000-0.029± 0.249
OG003-0.304± 0.711
Title
Measurements
OG000-0.045± 0.432
OG001-0.117± 0.356
OG002-0.016± 0.376
OG003-0.076± 0.254
Title
Measurements
OG00013.480± 4.193
OG00114.087± 4.285
OG00213.700± 5.397
OG00314.874± 5.904
Title
Measurements
OG0000.120± 0.662
OG003-1.961± 4.312
Title
Measurements
OG0000.450± 3.366
OG001-0.776± 1.405
OG002-0.084± 3.975
OG003-0.064± 1.375
Title
Measurements
OG0000.978± 0.553
OG0010.880± 0.563
OG0021.095± 0.656
OG0030.993± 0.757
Title
Measurements
OG000-0.009± 0.061
OG003-0.028± 0.096
Title
Measurements
OG000-0.016± 0.125
OG001-0.072± 0.119
OG002-0.045± 0.217
OG003-0.035± 0.150
1.495
± 3.3589
Title
Measurements
OG0000.445± 1.9595
OG0010.055± 2.9840
OG002-0.565± 1.4395
OG0030.475± 3.5101
Title
Measurements
OG0001.562± 2.4661
OG0015.715± 6.9239
OG0024.202± 4.8105
OG0031.626± 2.6861
Title
Measurements
OG0000.014± 0.8316
OG001-1.648± 7.1790
OG002-1.975± 3.2500
OG003-0.011± 1.2676
Title
Measurements
OG0001.2607± 1.77918
OG0012.1450± 2.39861
OG0021.2733± 0.96790
OG0031.6579± 3.35454
Title
Measurements
OG000-0.0886± 0.75890
OG001-0.2017± 2.43817
OG002-0.2067± 1.39370
OG0030.8122± 3.62090
Title
Measurements
OG0000.734± 1.2954
OG0012.602± 4.4908
OG0021.317± 1.5754
OG0030.429± 0.5696
Title
Measurements
OG000-0.025± 0.5104
OG001-1.510± 4.9524
OG002-0.795± 1.6009
OG0030.060± 0.6525
Title
Measurements
OG0004.921± 4.2218
OG00110.693± 17.4616
OG00213.507± 17.7231
OG0034.442± 3.9255
Title
Measurements
OG0000.813± 3.9116
OG001-4.692± 19.3477
OG002-7.322± 16.4934
OG0030.329± 2.3390
Title
Measurements
OG0003.348± 6.4940
OG0014.462± 4.1178
OG0024.458± 6.1968
OG0031.957± 2.7845
Title
Measurements
OG000-0.448± 2.4975
OG001-2.168± 5.1775
OG002-3.083± 5.3923
OG0030.070± 2.4772
Title
Measurements
OG0006.4300± 10.99806
OG0018.5333± 7.97928
OG0027.0033± 8.53321
OG0033.0983± 6.90958
Title
Measurements
OG000-1.0336± 5.35192
OG001-1.3283± 7.23188
OG002-2.8917± 5.30027
OG0030.3053± 3.13517
Title
Measurements
OG0003.1978± 7.08938
OG0013.1933± 3.01698
OG0022.6183± 3.21210
OG0031.5890± 4.46616
Title
Measurements
OG0000.0925± 1.10700
OG001-1.3300± 3.85666
OG002-1.5483± 3.27227
OG0030.1281± 0.84548
Title
Measurements
OG0001.781± 2.9291
OG0012.710± 3.7028
OG0022.810± 4.4518
OG0032.337± 4.6658
Title
Measurements
OG0000.217± 1.7957
OG001-1.327± 3.8703
OG002-0.907± 2.8144
OG0030.499± 4.0782
Title
Measurements
OG0001.0274± 1.44706
OG0011.8300± 3.00647
OG0021.5900± 1.79117
OG0032.2696± 4.71508
Title
Measurements
OG0000.3963± 1.70256
OG001-0.0767± 0.64252
OG002-0.5750± 1.02039
OG0030.6701± 4.70300
Title
Measurements
OG0006.443± 5.8006
OG00117.847± 32.7160
OG00214.040± 14.0133
OG0037.631± 8.2417
Title
Measurements
OG0000.502± 7.1412
OG001-8.062± 36.3708
OG0020.100± 9.5476
OG003-0.384± 5.8464
Title
Measurements
OG0001.768± 1.9872
OG0013.203± 3.6280
OG0024.095± 4.7768
OG0032.308± 3.0647
Title
Measurements
OG0000.241± 1.1929
OG001-1.615± 4.5191
OG002-0.782± 5.3918
OG003-0.276± 1.6589
Title
Measurements
OG0000.852± 2.5002
OG0012.355± 3.5388
OG0022.077± 2.0373
OG0030.262± 0.3381
Title
Measurements
OG0000.060± 0.8496
OG001-1.648± 3.7849
OG002-1.220± 1.7397
OG003-0.072± 0.1772
Title
Measurements
OG0007.910± 11.3177
OG00113.982± 16.1988
OG0028.167± 9.5488
OG0035.183± 6.5611
Title
Measurements
OG000-0.635± 6.6892
OG001-7.027± 19.5245
OG002-0.798± 7.1605
OG0030.597± 3.6401
Title
Measurements
OG0003.926± 5.7931
OG0016.287± 7.4576
OG0024.332± 4.0216
OG0033.690± 5.3754
Title
Measurements
OG0000.603± 5.1284
OG001-2.262± 9.1738
OG002-1.607± 4.1148
OG003-0.341± 2.2893
Title
Measurements
OG0004.817± 5.7702
OG00111.422± 16.0156
OG00211.952± 10.2915
OG0034.277± 4.8458
Title
Measurements
OG0000.427± 4.6695
OG001-6.123± 17.3744
OG002-5.898± 9.5001
OG0031.330± 4.8122
Title
Measurements
OG0003.229± 4.8212
OG0013.475± 2.2460
OG0022.980± 1.8997
OG0032.485± 3.8363
Title
Measurements
OG000-0.096± 2.8194
OG001-1.172± 2.2061
OG002-0.915± 1.0038
OG0030.054± 2.2468
Title
Measurements
OG00015.2372± 11.46102
OG00135.2000± 58.79083
OG00250.3175± 56.06189
OG00314.9554± 11.40262
Title
Measurements
OG0002.2418± 6.97357
OG001-18.0750± 61.75995
OG002-29.3558± 44.83082
OG0034.0988± 9.00464
Title
Measurements
OG0004.203± 6.4231
OG00110.857± 14.6665
OG0028.353± 8.4621
OG0032.609± 3.1856
Title
Measurements
OG0000.651± 3.5642
OG001-6.447± 16.0973
OG002-3.673± 8.5727
OG0031.136± 3.2837
Title
Measurements
OG0005.4506± 6.82628
OG00126.7958± 45.54328
OG00221.8742± 22.32961
OG0034.0902± 4.01659
Title
Measurements
OG0000.0455± 4.96426
OG001-21.4475± 46.04992
OG002-13.0942± 16.16771
OG0031.2437± 2.42526
Title
Measurements
OG0001.563± 2.0162
OG0015.743± 10.5586
OG0025.525± 6.4123
OG0031.138± 1.6187
Title
Measurements
OG0000.244± 1.8324
OG001-4.000± 11.1710
OG002-3.657± 6.6997
OG0030.087± 0.9350
Title
Measurements
OG0001.401± 2.0138
OG0011.897± 1.3080
OG0020.685± 0.3293
OG0031.797± 2.7461
Title
Measurements
OG0000.078± 1.0468
OG001-0.150± 1.3425
OG0020.190± 0.4725
OG0030.125± 1.8192
Title
Measurements
OG0002.610± 4.4802
OG0016.600± 12.2931
OG0025.630± 5.3371
OG0031.800± 2.2552
Title
Measurements
OG000-0.392± 1.7998
OG001-5.042± 12.7997
OG002-3.740± 4.4122
OG0030.066± 1.1380
Title
Measurements
OG0004.193± 9.8131
OG0030.116± 0.4689
Title
Measurements
OG0004.7775± 10.24616
OG0010.9900± NASince only 1 participant was analyzed, SD was not evaluated.
OG0033.9669± 8.68701
Title
Measurements
OG000-0.4586± 0.72158
OG003-0.4734± 4.04649
Title
Measurements
OG0003.881± 7.0122
OG0010.400± NASince only 1 participant was analyzed, SD was not evaluated.
OG0031.133± 1.0457
Title
Measurements
OG000-1.886± 5.4670
OG0030.307± 0.7307
Title
Measurements
OG0003.6185± 8.92846
OG0010.1000± NASince only 1 participant was analyzed, SD was not evaluated.
OG0031.2376± 1.90643
Title
Measurements
OG0000.0571± 0.20934
OG0030.0450± 0.63581
Title
Measurements
OG0007.2845± 10.00019
OG0013.3500± NASince only 1 participant was analyzed, SD was not evaluated.
OG0035.0124± 5.83330
Title
Measurements
OG0004.4443± 7.54015
OG0033.4794± 5.30014
Title
Measurements
OG00010.7965± 29.02953
OG0010.3600± NASince only 1 participant was analyzed, SD was not evaluated.
OG0032.9210± 4.10508
Title
Measurements
OG0000.2943± 0.63629
OG0030.2738± 1.49780
Title
Measurements
OG0002.482± 3.0844
OG0010.660± NASince only 1 participant was analyzed, SD was not evaluated.
OG0033.030± 2.6854
Title
Measurements
OG0004.399± 10.6094
OG0030.796± 1.8650
Title
Measurements
OG0003.6820± 3.59284
OG0010.2300± NASince only 1 participant was analyzed, SD was not evaluated.
OG0032.6629± 3.61369
Title
Measurements
OG0001.5329± 4.51498
OG0030.5931± 1.32472
Title
Measurements
OG0004.1090± 6.77642
OG0010.1300± NASince only 1 participant was analyzed, SD was not evaluated.
OG0032.0848± 2.59536
Title
Measurements
OG0003.3407± 8.56070
OG0030.5875± 1.62657
Title
Measurements
OG0001.104± 1.2697
OG0010.070± NASince only 1 participant was analyzed, SD was not evaluated.
OG0031.520± 2.4346
Title
Measurements
OG000-0.001± 0.3491
OG003-0.181± 0.9893
Title
Measurements
OG0006.760± 10.6571
OG0012.140± NASince only 1 participant was analyzed, SD was not evaluated.
OG0036.600± 9.0014
Title
Measurements
OG0001.833± 3.0611
OG0034.696± 13.8354
Title
Measurements
OG0002.1860± 2.85529
OG0010.3500± NASince only 1 participant was analyzed, SD was not evaluated.
OG0033.5831± 4.19998
Title
Measurements
OG0000.6293± 3.04077
OG0030.6431± 1.74757
Title
Measurements
OG0002.1680± 4.29056
OG0010.2700± NASince only 1 participant was analyzed, SD was not evaluated.
OG0031.2424± 1.21257
Title
Measurements
OG0001.1429± 2.54387
OG0030.3638± 0.72331
Title
Measurements
OG0005.6435± 7.09870
OG0018.9000± NASince only 1 participant was analyzed, SD was not evaluated.
OG00311.0210± 12.99039
Title
Measurements
OG0001.3686± 5.66545
OG003-1.0319± 3.43469
Title
Measurements
OG0004.717± 9.7429
OG0011.430± NASince only 1 participant was analyzed, SD was not evaluated.
OG0033.410± 3.5117
Title
Measurements
OG0000.209± 0.2118
OG0030.624± 1.4874
Title
Measurements
OG00016.0005± 15.82427
OG00117.4500± NASince only 1 participant was analyzed, SD was not evaluated.
OG0036.8752± 9.02378
Title
Measurements
OG000-2.0357± 4.29278
OG0031.4531± 3.87924
Title
Measurements
OG0004.083± 6.6047
OG0010.140± NASince only 1 participant was analyzed, SD was not evaluated.
OG0035.630± 7.8627
Title
Measurements
OG0008.439± 21.2741
OG0030.077± 1.0131
Title
Measurements
OG00024.5485± 44.24043
OG00113.7700± NASince only 1 participant was analyzed, SD was not evaluated.
OG00316.5624± 15.27894
Title
Measurements
OG0003.4457± 6.31401
OG0035.3575± 8.84223
Title
Measurements
OG0004.1040± 5.50276
OG0012.0500± NASince only 1 participant was analyzed, SD was not evaluated.
OG0033.3800± 3.26583
Title
Measurements
OG0002.3893± 4.24918
OG0031.2275± 2.05550
Title
Measurements
OG00011.5305± 18.12761
OG0010.7900± NASince only 1 participant was analyzed, SD was not evaluated.
OG0038.2971± 8.28676
Title
Measurements
OG000-0.2271± 5.08362
OG003-1.6638± 6.48421
Title
Measurements
OG0005.9930± 10.47744
OG0010.6700± NASince only 1 participant was analyzed, SD was not evaluated.
OG0033.8002± 6.40547
Title
Measurements
OG000-1.8500± 4.69494
OG0031.8431± 5.04651
Title
Measurements
OG0001.6980± 2.81930
OG0010.5600± NASince only 1 participant was analyzed, SD was not evaluated.
OG0031.9957± 2.72717
Title
Measurements
OG0001.9964± 5.10312
OG0030.2775± 0.60481
Title
Measurements
OG0005.500± 8.3404
OG0010.220± NASince only 1 participant was analyzed, SD was not evaluated.
OG0034.245± 4.6106
Title
Measurements
OG000-0.281± 0.4481
OG0030.203± 1.4614
3.30
± 3.674
Title
Measurements
OG000-0.07± 1.975
OG0010.07± 0.437
OG0021.07± 2.890
OG003-0.70± 2.398
Title
Measurements
OG0000.33± 0.511
OG0010.10± 0.089
OG0020.17± 0.163
OG0030.33± 0.444
Title
Measurements
OG000-0.06± 0.266
OG001-0.03± 0.082
OG0020.07± 0.163
OG003-0.07± 0.340
Title
Measurements
OG000-0.61± 1.178
OG0031.20± 6.948
Title
Measurements
OG0000.46± 0.465
OG0010.10± NASince only 1 participant was analyzed, SD was not evaluated.
OG0030.74± 1.027
Title
Measurements
OG000-0.01± 0.146
OG0030.06± 0.875
Title
Measurements
OG000-1.51± 18.94
OG001-15.55± 41.08
OG002-0.10± 18.22
OG003-0.48± 12.94
Title
Measurements
OG0007.30± 16.58
OG0032.63± 15.23
Title
Measurements
OG0006.86± 19.20
OG001-2.53± 8.52
OG002-5.88± 23.39
OG0036.07± 16.44
Title
Measurements
OG0000.96± 11.71
OG003-0.73± 40.24
Title
Measurements
OG0001.86± 19.22
OG001-6.73± 12.57
OG002-14.99± 11.74
OG0030.87± 45.16
Title
Measurements
OG000-1.32± 12.92
OG001-1.48± 10.13
OG0020.19± 14.22
OG003-2.98± 7.64
Title
Measurements
OG0000.63± 5.76
OG003-8.40± 18.97
Title
Measurements
OG0002.48± 19.59
OG001-3.84± 11.14
OG0021.05± 18.28
OG003-0.39± 9.81
Title
Measurements
OG000-1.25± 4.98
OG003-1.22± 18.25
Title
Measurements
OG000-3.62± 10.84
OG001-7.60± 12.86
OG002-1.25± 22.27
OG003-0.57± 11.85
159.298
± 788.0577
Title
Measurements
OG000-2.263± 52.3214
OG00117.857± 64.1746
OG002-26.089± 35.2991
OG0032.207± 57.5136
Title
Measurements
OG000-10.854± 34.9399
OG001530.405± 1313.1947
OG00216.282± 89.2804
OG00351.000± 205.2211
Title
Measurements
OG000-8.039± 43.2246
OG001-15.385± 70.4542
OG002-26.435± 50.4316
OG00326.481± 143.2057
Title
Measurements
OG00013.293± 54.1115
OG00181.053± 156.0747
OG0022.937± 88.0683
OG00323.064± 57.0094
Title
Measurements
OG000-8.215± 36.4547
OG001-7.761± 68.3190
OG002-40.573± 28.7097
OG00334.204± 179.4443
Title
Measurements
OG000-7.560± 54.4647
OG0011.928± 90.5777
OG002-27.272± 30.2249
OG00319.827± 120.4336
Title
Measurements
OG00013.540± 64.9487
OG001-14.917± 72.2397
OG002-19.919± 55.3947
OG00313.552± 54.9741
Title
Measurements
OG00013.302± 108.1678
OG00122.663± 111.5069
OG0022.985± 42.6740
OG00313.703± 137.0620
Title
Measurements
OG00032.983± 138.1448
OG001-3.399± 47.7558
OG002-13.591± 34.6936
OG00356.445± 189.5817
Title
Measurements
OG00019.729± 111.4367
OG001101.031± 168.5588
OG00211.364± 51.7417
OG00324.321± 83.4616
Title
Measurements
OG00051.134± 146.8640
OG001-16.656± 93.1140
OG00214.976± 131.8861
OG00318.956± 90.1198
Title
Measurements
OG000-4.445± 72.6724
OG001-5.463± 105.9311
OG002-41.416± 37.8396
OG003-11.447± 58.0173
Title
Measurements
OG000-3.087± 55.1562
OG001-31.375± 69.5715
OG0022.213± 83.1715
OG00320.278± 136.8606
Title
Measurements
OG00011.206± 116.7649
OG00117.353± 66.5358
OG002-5.380± 47.4598
OG00369.305± 570.5864
Title
Measurements
OG00020.238± 90.3348
OG0011.009± 53.3534
OG002-29.346± 51.5854
OG00351.187± 152.3694
Title
Measurements
OG00014.720± 64.9702
OG001-14.827± 57.5927
OG002-30.608± 35.7004
OG00343.454± 218.7604
Title
Measurements
OG00021.433± 55.0044
OG00144.814± 73.1928
OG002-16.275± 73.1979
OG00332.146± 64.1971
Title
Measurements
OG00054.691± 114.1882
OG0015.412± 83.2939
OG002-20.778± 54.8585
OG003101.397± 221.3435
Title
Measurements
OG00035.202± 90.9529
OG001-37.641± 33.1824
OG002-53.328± 21.6352
OG00375.407± 168.3388
Title
Measurements
OG00011.419± 127.0639
OG00123.828± 108.3336
OG002-27.150± 51.7944
OG00320.048± 139.8965
Title
Measurements
OG0000.215± 50.6348
OG00118.204± 57.8187
OG00235.862± 55.9954
OG00322.329± 156.8530
Title
Measurements
OG0002.245± 65.7260
OG001-3.348± 64.8128
OG002-47.069± 32.3779
OG00323.533± 102.5771
Title
Measurements
OG00019.517± 194.1378
OG00139.032± 83.7958
OG00229.887± 80.9696
OG003-11.895± 48.3260
Title
Measurements
OG00015.310± 141.4934
OG001-50.000± 70.7107
OG00277.083± 156.8461
OG003-8.842± 52.9312
Title
Measurements
OG000-20.725± 23.3306
OG00315.437± 65.9854
Title
Measurements
OG000-3.370± 38.0473
OG00340.604± 72.3862
Title
Measurements
OG0006.349± 31.2778
OG00332.033± 125.5527
Title
Measurements
OG00039.578± 34.1628
OG00368.850± 127.9989
Title
Measurements
OG00011.800± 36.9732
OG00343.759± 97.2095
Title
Measurements
OG00067.784± 90.5075
OG00325.297± 48.3430
Title
Measurements
OG00028.981± 76.3568
OG00341.622± 84.8290
Title
Measurements
OG00018.274± 61.3305
OG00319.616± 74.2945
Title
Measurements
OG000-7.707± 27.1098
OG003-0.573± 35.9671
Title
Measurements
OG00062.824± 94.6871
OG00360.437± 145.3385
Title
Measurements
OG00012.392± 69.6069
OG00329.295± 118.2639
Title
Measurements
OG00021.768± 44.1688
OG00362.768± 118.4103
Title
Measurements
OG00077.551± 191.9769
OG00318.059± 75.7757
Title
Measurements
OG00014.160± 16.8040
OG00327.188± 56.4211
Title
Measurements
OG000-14.128± 20.3094
OG00319.712± 69.9092
Title
Measurements
OG00036.970± 99.7771
OG0038.882± 41.3781
Title
Measurements
OG00015.179± 28.0371
OG00344.140± 113.5780
Title
Measurements
OG00054.773± 49.4505
OG00346.995± 90.7514
Title
Measurements
OG0001.131± 51.4091
OG0030.714± 49.6361
Title
Measurements
OG000-14.748± 45.9399
OG00338.974± 83.4963
Title
Measurements
OG00052.210± 75.6486
OG00316.859± 40.1773
Title
Measurements
OG0000.600± 31.4400
OG00326.241± 66.5051
Title
Measurements
OG000-6.387± 18.2069
OG00327.872± 128.3927
Title
Measurements
OG0000.000± 34.0588
OG00328.845± 132.2208
0.7
± 0.6
OG0012.1± 1.3
OG0021.9± 2.1
5.5
± 2.0
OG00117.1± 4.1
OG00245.5± 16.5
7.0
± 3.3
OG00123.7± 7.2
OG00253.6± 19.7
7.9
± 4.2
OG00125.9± 5.6
OG00252.5± 20.5
3.9
± 1.6
OG00112.7± 3.7
OG00234.7± 19.1
36.1
± 23.2
3.4
± 1.5
OG00111.3± 5.2
OG00234.6± 20.8
3.7
± 1.5
OG00112.8± 4.8
OG00232.0± 18.6
0.9
± 0.6
OG0014.1± 2.3
OG00212.6± 10.3
0.4
± NA
Since only 1 participant was evaluated, standard deviation was not estimable.