A Study Comparing Different Dosing Regimens of Ixekizumab... | NCT02513550 | Trialant
NCT02513550
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 17, 2020Actual
Enrollment
1,257Actual
Phase
Phase 3
Conditions
Plaque Psoriasis
Interventions
Ixekizumab
Placebo
Countries
United States
Argentina
Australia
Canada
Czechia
Germany
Hungary
Japan
Mexico
Poland
Puerto Rico
Romania
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02513550
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
15988
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBP
Other Identifier
Eli Lilly and Company
2015-000190-12
EudraCT Number
Brief Title
A Study Comparing Different Dosing Regimens of Ixekizumab (LY2439821) in Participants With Moderate to Severe Plaque Psoriasis
Official Title
A Multicenter, Randomized, Double-Blind Study Comparing the Efficacy and Safety of Ixekizumab Dosing Regimens in Patients With Moderate-to-Severe Plaque Psoriasis
Acronym
IXORA-P
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2020
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
Aug 2015
Primary Completion Date
Nov 2016Actual
Completion Date
Aug 3, 2017Actual
First Submitted Date
Jul 30, 2015
First Submission Date that Met QC Criteria
Jul 30, 2015
First Posted Date
Jul 31, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Nov 20, 2017
Results First Submitted that Met QC Criteria
Mar 19, 2018
Results First Posted Date
Apr 18, 2018Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 10, 2020
Last Update Posted Date
Jun 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the efficacy of ixekizumab dosing regimens in participants with plaque psoriasis.
Detailed Description
The purpose of this study is to evaluate both the safety and efficacy of ixekizumab dosing regimens. There are 3 study periods: Screening Period, Blinded Treatment Dosing Period, and Post-Treatment Follow-Up.
Conditions Module
Conditions
Plaque Psoriasis
Keywords
Not provided
Design Module
Study Type
Interventional
Number of References to an Expanded Access Study
Not provided
Expanded Access Types
Not provided
Patient Registry
Not provided
Target Follow-Up Duration
Not provided
Phases
Phase 3
Interventional Study Design
Allocation
Biospecimen
No data available
No data is available for this block.
Enrollment
1,257Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
80 mg Ixekizumab Q2W
Experimental
160 milligrams (mg) ixekizumab given as 2 subcutaneous (SQ) injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 2 weeks (Q2W) to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Drug: Placebo
80 mg Ixekizumab Q4W
Experimental
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection every 4 weeks (Q4W) to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Drug: Placebo
80 mg Ixekizumab Q4W/Q2W
Experimental
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Drug: Placebo
80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
Experimental
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Drug: Placebo
80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SQ
80 mg Ixekizumab Q2W
80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
80 mg Ixekizumab Q4W
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Week 52
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
Week 52
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving sPGA (0)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Present with chronic plaque psoriasis for at least 6 months prior to enrollment
At least 10% BSA of psoriasis at screening and at enrollment
sPGA score of at least 3 and PASI score of at least 12 at screening and at enrollment
Candidates for phototherapy and/or systemic therapy
Participant must agree to use reliable method of birth control during the study; women must continue using birth control for at least 12 weeks after stopping treatment
Exclusion Criteria:
Predominant pattern of pustular, erythrodermic, or guttate forms of psoriasis
History of drug-induced psoriasis
Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study
Received systemic non-biologic psoriasis therapy or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to enrollment
Concurrent or recent use of any biologic agent
Have participated in any study with ixekizumab
Received a live vaccination within 12 weeks prior to enrollment
Serious disorder or illness other than psoriasis
Ongoing or serious infection within the last 12 weeks or evidence of tuberculosis
Major surgery within 8 weeks of baseline, or will require surgery during the study
Breastfeeding or nursing (lactating) women
Accepts Healthy Volunteers
No
Sex
All
Sex/Gender Based
Not provided
Sex/Gender Description
Not provided
Minimum Age
18 Years
Maximum Age
Not provided
Standard Ages
AdultOlder Adult
Study Population
Not provided
Sampling Method
Not provided
Contacts/Locations Module
Central Contacts
Not provided
Overall Officials
Name
Affiliation
Role
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Director
Locations
Facility
Status
City
State
ZIP
Country
Contacts
Total Skin and Beauty Dermatology Center PC
Birmingham
Alabama
35205
United States
Anaheim Clinical Trials, LLC
References Module
No data available
No data is available for this block.
IPD Sharing Statement Module
Plan to Share IPD
Yes
Description
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
FG001
80 mg Ixekizumab Q4W/Q2W
Periods
Title
Milestones
Reasons Not Completed
Double Blind Treatment Period
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
No data available
No data is available for this block.
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Brazil
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
No data available
No data is available for this block.
Intervention Browse Module
MeSH Terms
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
Experimental
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Drug: Placebo
80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
Experimental
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Drug: Ixekizumab
Drug: Placebo
80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
80 mg Ixekizumab Q4W/Q2W
80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
LY2439821
Placebo
Drug
Administered SQ
80 mg Ixekizumab Q2W
80 mg Ixekizumab Q2W Maximum Extended Enrollment (ME2) Cohort
80 mg Ixekizumab Q4W
80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
80 mg Ixekizumab Q4W/Q2W
80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
Week 52
Percentage of Participants Achieving PASI 90
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Week 52
Percentage of Participants Achieving PASI 100
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Week 52
Change From Baseline in PASI
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Percent Improvement in PASI
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Mean Change From Baseline in Palmoplantar PASI (PPASI)
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Baseline, Week 52
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
Week 52
Change From Baseline in DLQI Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Change From Baseline in Itch NRS Score
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Change From Baseline in Skin Pain Visual Analog Scale (VAS)
The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
Baseline, Week 52
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Trough concentrations at steady state of Ixekizumab were evaluated.
Predose, Week 4, 12, 24, 36 and 52 Post dose
Number of Participants With Anti-Ixekizumab Antibodies
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
Baseline through Week 52
Anaheim
California
92801
United States
David Stoll, M.D.
Beverly Hills
California
90212
United States
Dermatology Research Associates
Los Angeles
California
90045
United States
Center for Dermatology and Laser Surgery
Sacramento
California
95819
United States
Medical Center for Clinical Research
San Diego
California
92108
United States
University Clinical Trials, Inc.
San Diego
California
92123
United States
Clinical Science Institute
Santa Monica
California
90404
United States
Cherry Creek Research, Inc
Denver
Colorado
80209
United States
Florida Academic Dermatology Centers
Coral Gables
Florida
33134
United States
Avail Clinical Research LLC
DeLand
Florida
32720
United States
Jacksonville Center for Clinical Research
Jacksonville
Florida
32216
United States
Renstar Medical Research
Ocala
Florida
34471
United States
Ameriderm Research
Ormond Beach
Florida
32174
United States
University of South Florida
Tampa
Florida
33624
United States
Advanced Medical Research
Atlanta
Georgia
30342
United States
University Dermatology
Darien
Illinois
60561
United States
Deaconess Clinic Inc
Evansville
Indiana
47714
United States
Dawes Fretzin Clinical Research
Indianapolis
Indiana
46256
United States
The South Bend Clinic
South Bend
Indiana
46617
United States
Kansas City Dermatology, PA
Overland Park
Kansas
66215
United States
Heartland Research Associates
Wichita
Kansas
67207
United States
Dermatology Specialist
Louisville
Kentucky
40202
United States
Dr. Shondra Smith MD
Lake Charles
Louisiana
70605
United States
DermAssociates, P.C.
Rockville
Maryland
20850
United States
ActivMed Practices & Research, Inc
Beverly
Massachusetts
01915
United States
Central Dermatology PC
St Louis
Missouri
63117
United States
ActivMed Practices & Research, Inc
Newington
New Hampshire
03801
United States
Psoriasis Treatment Center of Central New Jersey
East Windsor
New Jersey
08520
United States
Academic Dermatology Associates
Albuquerque
New Mexico
87106-5239
United States
Mount Sinai School of Medicine Dermatology Clinical Trials
New York
New York
10029
United States
Skin Search of Rochester, Inc
Rochester
New York
14623
United States
University of North Carolina Dermatology and Skin Cancer Center
Chapel Hill
North Carolina
27516
United States
PMG Research of Wilmington, LLC
Wilmington
North Carolina
28401
United States
Wilmington Dermatology Center
Wilmington
North Carolina
28405
United States
Piedmont Medical Research
Winston-Salem
North Carolina
27103
United States
University Hospitals of Cleveland
Cleveland
Ohio
44106-5055
United States
Healthcare Research Consultant
Tulsa
Oklahoma
74135
United States
Oregon Dermatology and Research Center
Portland
Oregon
97210
United States
Oregon Medical Research Center
Portland
Oregon
97223
United States
Dermatology and Skin Surgery Center
Exton
Pennsylvania
19341
United States
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
15213
United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Wyomissing
Pennsylvania
19610
United States
Yardley Dermatology
Yardley
Pennsylvania
19067
United States
Clinical Partners LLC
Johnston
Rhode Island
02919
United States
Coastal Carolina Research Center, Inc.
Mt. Pleasant
South Carolina
29464
United States
The Skin Wellness Center PC
Knoxville
Tennessee
37922
United States
Austin Dermatology Associates
Austin
Texas
78705
United States
Menter Dermatology Research Institute
Dallas
Texas
75246
United States
Center for Clinical Studies
Houston
Texas
77004
United States
Center for Clinical Studies
Houston
Texas
77065
United States
Pflugerville Dermatology Clinical Research Center
Pflugerville
Texas
78660
United States
Clinical Trials of Texas, Inc.
San Antonio
Texas
78229
United States
Center for Clinical Studies
Webster
Texas
77598
United States
University of Utah Medical Center
Salt Lake City
Utah
84132
United States
Virginia Clinical Research
Norfolk
Virginia
23507
United States
Dermatology Associates
Seattle
Washington
98101
United States
Multicare Health System
Tacoma
Washington
98405
United States
Wenatchee Valley Hospital & Clinics
Wenatchee
Washington
98801
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Buenos Aires
C1425DKG
Argentina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Mendoza
5500
Argentina
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Benowa
4217
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Carlton
3053
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Darlinghurst
2010
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Fremantle
6160
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Phillip
02606
Australia
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Woolloongabba
4102
Australia
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Barrie
L4M 6L2
Canada
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Calgary
T2G 1B1
Canada
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Halifax
B3H1Z2
Canada
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Hamilton
L8N1V6
Canada
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London
N6A 3H7
Canada
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Markham
L3P1X2
Canada
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Montreal
H2K4L5
Canada
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Oakville
L6J7W5
Canada
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Peterborough
K9J 5K2
Canada
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Québec
G1V 4X7
Canada
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Richmond Hill
L4B 1A5
Canada
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Sherbrooke
J1J 2G2
Canada
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Surrey
V3V 0C6
Canada
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Waterloo
N2J 1C4
Canada
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Windsor
N8W 1E6
Canada
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Brno
656 91
Czechia
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Nový Jičín
741 01
Czechia
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Plzen-Bory
305-99
Czechia
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Prague
100 34
Czechia
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Berlin
10789
Germany
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Darmstadt
64283
Germany
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Kiel
24148
Germany
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Mahlow
15831
Germany
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Münster
48159
Germany
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Budapest
1238
Hungary
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Debrecen
4032
Hungary
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Orosháza
5901
Hungary
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Szolnok
5000
Hungary
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Osaka
545-8586
Japan
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Takaoka
9330871
Japan
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Tsu
514-8507
Japan
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Mexicali
21100
Mexico
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Mexico City
3100
Mexico
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Monterrey
64060
Mexico
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Morelia
CP 58249
Mexico
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Bialystok
15-351
Poland
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Gdansk
80-546
Poland
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Kielce
25-316
Poland
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Krakow
30-438
Poland
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Lodz
90-265
Poland
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Szczecin
70-332
Poland
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Świdnik
21-040
Poland
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Wroclaw
51-318
Poland
Office of Dr. Samuel Sanchez PSC
Caguas
00727
Puerto Rico
Office of Dr. Alma M. Cruz
Carolina
00985
Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce
00716
Puerto Rico
GCM Medical Group PSC
San Juan
00909
Puerto Rico
Mindful Medical Research
San Juan
00918
Puerto Rico
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Bucharest
011025
Romania
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Cluj-Napoca
400006
Romania
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Constanța
900125
Romania
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Craiova
200642
Romania
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Bucheon-si
420-717
South Korea
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Pusan
602-739
South Korea
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Seongnam
463-707
South Korea
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Seoul
100799
South Korea
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Tainan
70166
Taiwan
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Taipei
10048
Taiwan
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
FG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
FG003
80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
FG004
80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
FG005
80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
FG000310 subjects
FG001306 subjects
FG002611 subjects
FG0039 subjects
FG0045 subjects
FG00516 subjects
Received at Least One Dose of Study Drug
FG000310 subjects
FG001306 subjects
FG002609 subjects
FG0039 subjects
FG0045 subjects
FG00516 subjects
COMPLETED
FG000274 subjects
FG001268 subjects
FG002537 subjects
FG0039 subjects
FG0044 subjects
FG00515 subjects
NOT COMPLETED
FG00036 subjects
FG00138 subjects
FG00274 subjects
FG0030 subjects
FG0041 subjects
FG0051 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG00011 subjects
FG00111 subjects
FG00225 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0005 subjects
FG00113 subjects
FG00217 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0009 subjects
FG0017 subjects
FG00211 subjects
FG0030 subjects
FG004
Lack of Efficacy
FG0004 subjects
FG0015 subjects
FG0026 subjects
FG0030 subjects
FG004
Protocol Violation
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG004
Physician Decision
FG0002 subjects
FG0010 subjects
FG0024 subjects
FG0030 subjects
FG004
Site terminated by sponsor
FG0001 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
FG004
Met exclusion criteria and was not dosed
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Due to personal business
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Death
FG0001 subjects
FG0010 subjects
FG0022 subjects
FG0030 subjects
FG004
Post-Treatment Follow-up Period
Type
Comment
Milestone Data
STARTED
FG000285 subjectsParticipants who discontinued double blind phase had an option to enter post-treatment phase.
FG001283 subjectsParticipants who discontinued double blind phase had an option to enter post-treatment phase.
FG002559 subjectsParticipants who discontinued double blind phase had an option to enter post-treatment phase.
FG0039 subjectsParticipants who discontinued double blind phase had an option to enter post-treatment phase.
FG0044 subjectsParticipants who discontinued double blind phase had an option to enter post-treatment phase.
FG00515 subjectsParticipants who discontinued double blind phase had an option to enter post-treatment phase.
COMPLETED
FG000254 subjects
FG001244 subjects
FG002496 subjects
FG0039 subjects
FG004
NOT COMPLETED
FG00031 subjects
FG00139 subjects
FG00263 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG00012 subjects
FG00120 subjects
FG00226 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
BG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
BG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
BG003
80 mg Ixekizumab Q4W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
BG004
80 mg Ixekizumab Q4W/Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
BG005
80 mg Ixekizumab Q2W Maximum Extended Enrollment Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
BG006
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000310
BG001306
BG002611
BG0039
BG0045
BG00516
BG0061257
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
All randomized participants who received at least one dose of study drug and had baseline age data.
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002609
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Puerto Rico
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002
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
Percentage of Participants Achieving Static Physician Global Assessment (sPGA) of (0,1)
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000310
OG001306
OG002611
Title
Denominators
Categories
Title
Measurements
OG00070.6
OG00172.5
OG00278.6
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
OG002
Regression, Logistic
=0.005
Risk Difference (RD)
7.9
2-Sided
Superiority
OG000
OG001
Regression, Logistic
=0.522
Primary
Percentage of Participants Achieving 75% Improvement in Psoriasis Area and Severity Index (PASI 75)
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease). Participants who did not meet the clinical response criteria or had missing data at Week52 were considered non-responders for NRI analysis.
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Percentage of Participants Achieving sPGA (0)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of "0" or "1" with at least a 2-point improvement from baseline. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Percentage of Participants Achieving PASI 90
PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
Secondary
Percentage of Participants Achieving PASI 100
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease. For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
Secondary
Change From Baseline in PASI
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Percent Improvement in PASI
The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of scaling, redness, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no Ps to 72 for the most severe disease.
Least Squares mean (LSmean) was calculated using Mixed-Effects Model of Repeated Measures (MMRM) analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and had a baseline and post-baseline measurement for PASI. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
Percent change
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Mean Change From Baseline in Percent Body Surface Area (BSA) Involvement
The percentage involvement of psoriasis on each participant's body surface area (BSA) was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand including palm, fingers and thumb.
LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned who had baseline and a post-baseline measurement for BSA affected by Psoriasis. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
Percent Body Surface Affected
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI) Score
The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail (fn) Ps. This scale is used to evaluate the severity of fn bed Ps and fn matrix Ps by area of involvement in the fn unit. The fn is divided with imaginary horizontal and longitudinal lines into quadrants. Each fn is given a score for fn bed Ps (0 to 4) and fn matrix Ps (0 to 4) depending on presence (score of 1) or absence (score of 0) of any of the features of fn bed and fn matrix Ps in each quadrant. The NAPSI score of a fn is sum of scores in fn bed and fn matrix from each quadrant (maximum of 8). Each fn is evaluated, then the sum of all fn equals the total NAPSI score with a range from 0 to 80 (0 indicates no Ps, 80 indicates worst Ps). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned who had baseline fingernail involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Mean Change From Baseline in Psoriasis Scalp Severity Index (PSSI) Score
The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90-100%) with a total score ranging from 0 (less severity) to 72 (more severity). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and had baseline scalp involvement and had a post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
Secondary
Mean Change From Baseline in Palmoplantar PASI (PPASI)
The Palmoplantar PASI is a composite score derived from the sum scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement, ranging from 0 (no PPASI) to 72 (most severe PPASI). The PPASI was only assessed if participants have palmoplantar psoriasis at baseline. LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and had baseline palmoplantar Ps involvement and had post-baseline measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Percentage of Participants Achieving an Itch Numeric Rating Scale (Itch NRS) ≥4 Point Reduction From Baseline
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline Itch NRS score greater than or equal to (>=) 4. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups
Posted
Number
Percentage of participants
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Percentage of Participants Achieving Dermatology Life Quality Index (DLQI) Total Score of 0 and 1 (DLQI [0,1])
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). Participants who did not meet the clinical response criteria or had missing data at Week 52 were considered non-responders for Non-Responder Imputation (NRI) analysis.
All randomized participants analyzed according to the treatment to which they were assigned. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
Percentage of participants
Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Change From Baseline in DLQI Total Score
The DLQI is a simple, participant-administered, 10 question, validated, quality-of-life questionnaire that covers 6 domains: symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include "not at all," "a lot," and "very much," with corresponding scores of 1, 2, and 3, respectively, and unanswered ("not relevant") responses scored as "0." Totals range from 0 to 30 (less to more impairment). LS mean change was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline DLQI data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind..
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Change From Baseline in Itch NRS Score
The Itch NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours. LS mean change from baseline in PSSI was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline Itch NRS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Change From Baseline in Skin Pain Visual Analog Scale (VAS)
The pain VAS is a participant-administered single-item scale designed to measure Skin pain from Psoriasis using a 0-100 millimeter (mm) horizontal VAS. Overall severity of participant's skin pain from Psoriasis is indicated by placing a single mark on the horizontal 100 mm scale from 0 mm (no skin pain) to 100 mm (severe skin pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post-baseline skin pain VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
mm
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Change From Baseline in European Quality of Life - 5 Dimensions 5 Level (EQ-5D-5L) VAS
EQ-5D-5L is a standardized measure of health status used to provide a simple, generic measure of health for clinical and economic appraisal. The EQ-5D-5L consists of 2 components: a descriptive system of the respondent's health and a rating of his/her current health state using a 0 (no pain) to 100mm VAS (severe pain). LS mean was calculated using MMRM analysis including dosing regimen, country, baseline weight category, baseline value, visit, dosing regimen-by-visit, and baseline value-by-visit interactions as fixed factors, with variance-covariance structure set to unstructured.
All randomized participants analyzed according to the treatment to which they were assigned and who had baseline and post baseline EQ-5D-5L VAS data. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Least Squares Mean
Standard Error
mm
Baseline, Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough,ss) of Ixekizumab
Trough concentrations at steady state of Ixekizumab were evaluated.
All randomized participants analyzed according to treatment to which they were assigned with evaluable PK samples that met the definition of being a trough concentration. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per milliliter (µg/mL)
Predose, Week 4, 12, 24, 36 and 52 Post dose
ID
Title
Description
OG000
80 mg Ixekizumab Q4W Continuous
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W No Step
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q4W/Q2W Step up
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
Secondary
Number of Participants With Anti-Ixekizumab Antibodies
Number of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment group.
All randomized participants who received at least 1 dose of Ixekizumab and had evaluable anti-ixekizumab antibody measurement. As pre-specified in the analysis plan, outcome measures will not be reported for the Maximum Extended Enrollment (ME2) arms/groups but only for the main global study arms/groups.
Posted
Number
participants
Baseline through Week 52
ID
Title
Description
OG000
80 mg Ixekizumab Q4W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Time Frame
Up to 19 months
Description
All randomized participants who received at least one dose of study drug. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
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
Ixekizumab 80 mg Q4W - Treatment Period
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
0
310
16
310
157
310
EG001
80 mg Ixekizumab Q4W/Q2W - Treatment Period
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
0
306
16
306
136
306
EG002
80 mg Ixekizumab Q2W - Treatment Period
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
0
609
32
609
285
609
EG003
80 mg Ixekizumab Q4W - Post-Treatment Period
Participants didn't receive any intervention.
0
285
1
285
16
285
EG004
80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period
Participants didn't receive any intervention.
0
283
2
283
20
283
EG005
80 mg Ixekizumab Q2W - Post-Treatment Period
Participants didn't receive any intervention.
0
559
7
559
40
559
EG006
80 mg Ixekizumab Q4W - Treatment Period ME2 Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q4W to week 52. Placebo administered SQ, Q2W to maintain blind.
0
9
0
9
6
9
EG007
80 mg Ixekizumab Q4W/Q2W - Treatment Period ME2 Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
0
5
1
5
4
5
EG008
80 mg Ixekizumab Q2W - Treatment Period ME2 Cohort
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
0
16
0
16
11
16
EG009
80 mg Ixekizumab Q4W - Post-Treatment Period ME2 Cohort
Participants didn't receive any intervention.
0
9
0
9
2
9
EG010
80 mg Ixekizumab Q4W/Q2W - Post-Treatment Period ME2 Cohort
Participants didn't receive any intervention.
0
4
0
4
0
4
EG011
80 mg Ixekizumab Q2W - Post-Treatment Period ME2 Cohort
Participants didn't receive any intervention.
0
15
0
15
2
15
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0023 events1 affected609 at risk
EG0030 events0 affected285 at risk
EG0040 events0 affected283 at risk
EG0050 events0 affected559 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected5 at risk
EG0080 events0 affected16 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected15 at risk
Atrial fibrillation
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Cardiac failure
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0022 events2 affected609 at risk
EG003
Coronary artery disease
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0012 events1 affected306 at risk
EG0022 events2 affected609 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Pericarditis
Cardiac disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Goitre
Endocrine disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Gastroenteritis eosinophilic
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0022 events1 affected609 at risk
EG003
Gastrointestinal haemorrhage
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Intra-abdominal haematoma
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Oesophageal rupture
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Pancreatitis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Umbilical hernia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Chest discomfort
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Non-cardiac chest pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0022 events2 affected609 at risk
EG003
Vascular stent restenosis
General disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Cholecystitis acute
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Cholecystitis chronic
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Drug hypersensitivity
Immune system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Abscess limb
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Abscess oral
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Carbuncle
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected310 at risk
EG0012 events2 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Chronic sinusitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Chronic tonsillitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Gastroenteritis shigella
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Pyelonephritis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Pyelonephritis acute
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Sepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Urosepsis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Clavicle fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Hand fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Injury
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Joint dislocation
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Lower limb fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Pelvic fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Rib fracture
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0012 events2 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Wound dehiscence
Injury, poisoning and procedural complications
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
International normalised ratio increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Diabetic ketoacidosis
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Gout
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Hypokalaemia
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Lactic acidosis
Metabolism and nutrition disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Cartilage hypertrophy
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Intervertebral disc compression
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Musculoskeletal chest pain
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0022 events1 affected609 at risk
EG003
Adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Adenocarcinoma gastric
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Adenocarcinoma of colon
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Benign bone neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Breast cancer metastatic
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Colon cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Dermatofibrosarcoma protuberans
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Invasive breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Invasive ductal breast carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Neurilemmoma benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Plasma cell myeloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Basilar migraine
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Hyposmia
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Transient ischaemic attack
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Ectopic pregnancy
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected199 at risk
EG003
Tubal rupture
Pregnancy, puerperium and perinatal conditions
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0010 events0 affected107 at risk
EG0020 events0 affected199 at risk
EG003
Anxiety
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Major depression
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Stress
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Suicide attempt
Psychiatric disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Renal haematoma
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Urinary retention
Renal and urinary disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected199 at risk
EG0010 events0 affected199 at risk
EG0020 events0 affected410 at risk
EG003
Pulmonary microemboli
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Dermatitis contact
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Rash macular
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Stevens-johnson syndrome
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Deep vein thrombosis
Vascular disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Neutropenia
Blood and lymphatic system disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected310 at risk
EG0010 events0 affected306 at risk
EG0022 events1 affected609 at risk
EG0030 events0 affected285 at risk
EG0040 events0 affected283 at risk
EG0051 events1 affected559 at risk
EG0060 events0 affected9 at risk
EG0070 events0 affected5 at risk
EG0081 events1 affected16 at risk
EG0090 events0 affected9 at risk
EG0100 events0 affected4 at risk
EG0110 events0 affected15 at risk
Retinal vein occlusion
Eye disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Dry mouth
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0012 events2 affected306 at risk
EG0022 events2 affected609 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected310 at risk
EG0011 events1 affected306 at risk
EG0024 events4 affected609 at risk
EG003
Gastric ulcer
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected310 at risk
EG0011 events1 affected306 at risk
EG0024 events4 affected609 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Injection site erythema
General disorders
MedDRA 20.0
Systematic Assessment
EG00014 events4 affected310 at risk
EG0014 events3 affected306 at risk
EG00249 events18 affected609 at risk
EG003
Injection site oedema
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Injection site pain
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected310 at risk
EG0017 events6 affected306 at risk
EG00226 events8 affected609 at risk
EG003
Injection site pruritus
General disorders
MedDRA 20.0
Systematic Assessment
EG0004 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG00213 events4 affected609 at risk
EG003
Injection site reaction
General disorders
MedDRA 20.0
Systematic Assessment
EG00068 events18 affected310 at risk
EG00115 events5 affected306 at risk
EG002256 events49 affected609 at risk
EG003
Injection site swelling
General disorders
MedDRA 20.0
Systematic Assessment
EG00011 events2 affected310 at risk
EG0010 events0 affected306 at risk
EG00211 events7 affected609 at risk
EG003
Xerosis
General disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0012 events2 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Furuncle
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected310 at risk
EG0011 events1 affected306 at risk
EG0025 events5 affected609 at risk
EG003
Hordeolum
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0007 events4 affected310 at risk
EG0012 events2 affected306 at risk
EG0024 events4 affected609 at risk
EG003
Influenza
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0006 events6 affected310 at risk
EG00110 events9 affected306 at risk
EG0025 events5 affected609 at risk
EG003
Mumps
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0004 events3 affected310 at risk
EG0014 events3 affected306 at risk
EG0028 events8 affected609 at risk
EG003
Tinea pedis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0006 events6 affected310 at risk
EG0014 events4 affected306 at risk
EG00210 events8 affected609 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0002 events1 affected310 at risk
EG0012 events2 affected306 at risk
EG0026 events6 affected609 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00060 events46 affected310 at risk
EG00156 events39 affected306 at risk
EG00293 events69 affected609 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00021 events16 affected310 at risk
EG0014 events4 affected306 at risk
EG00220 events15 affected609 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected111 at risk
EG0011 events1 affected107 at risk
EG0020 events0 affected199 at risk
EG003
Viral upper respiratory tract infection
Infections and infestations
MedDRA 20.0
Systematic Assessment
EG00049 events41 affected310 at risk
EG00169 events53 affected306 at risk
EG00289 events73 affected609 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0007 events7 affected310 at risk
EG0012 events2 affected306 at risk
EG0023 events3 affected609 at risk
EG003
Aspartate aminotransferase increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0005 events5 affected310 at risk
EG0012 events2 affected306 at risk
EG0023 events3 affected609 at risk
EG003
Blood glucose increased
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Helicobacter test positive
Investigations
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Arthralgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0008 events7 affected310 at risk
EG0015 events5 affected306 at risk
EG00229 events25 affected609 at risk
EG003
Myalgia
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected310 at risk
EG0010 events0 affected306 at risk
EG0026 events6 affected609 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected310 at risk
EG0012 events2 affected306 at risk
EG0024 events4 affected609 at risk
EG003
Periarthritis
Musculoskeletal and connective tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Benign bone neoplasm
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Dizziness
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG00210 events9 affected609 at risk
EG003
Headache
Nervous system disorders
MedDRA 20.0
Systematic Assessment
EG00016 events14 affected310 at risk
EG00118 events16 affected306 at risk
EG00234 events29 affected609 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG00011 events11 affected310 at risk
EG0013 events2 affected306 at risk
EG00225 events23 affected609 at risk
EG003
Dysphonia
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0010 events0 affected306 at risk
EG0020 events0 affected609 at risk
EG003
Epistaxis
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0001 events1 affected310 at risk
EG0010 events0 affected306 at risk
EG0023 events3 affected609 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 20.0
Systematic Assessment
EG0006 events6 affected310 at risk
EG0015 events5 affected306 at risk
EG00217 events17 affected609 at risk
EG003
Dermal cyst
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected310 at risk
EG0011 events1 affected306 at risk
EG0022 events2 affected609 at risk
EG003
Dry skin
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0000 events0 affected310 at risk
EG0011 events1 affected306 at risk
EG0021 events1 affected609 at risk
EG003
Dyshidrotic eczema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0002 events2 affected310 at risk
EG0011 events1 affected306 at risk
EG0022 events2 affected609 at risk
EG003
Eczema
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0008 events6 affected310 at risk
EG0016 events5 affected306 at risk
EG00212 events11 affected609 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0004 events4 affected310 at risk
EG0013 events3 affected306 at risk
EG0023 events3 affected609 at risk
EG003
Rash
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected310 at risk
EG0013 events3 affected306 at risk
EG0024 events4 affected609 at risk
EG003
Urticaria
Skin and subcutaneous tissue disorders
MedDRA 20.0
Systematic Assessment
EG0003 events3 affected310 at risk
EG0014 events4 affected306 at risk
EG0027 events6 affected609 at risk
EG003
Certain Agreements
Are all PI(s) employees of the sponsor?
No
Restriction Type
GT60
Results Disclosure Restriction on PI(s)?
Yes
Other Details
Not provided
Point of Contact
Title
Organization
Phone
Extension
Email
Chief Medical Officer
Eli Lilly and Company
800-545-5979
ID
Term
C549079
ixekizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
1 subjects
FG0050 subjects
0 subjects
FG0051 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
0 subjects
FG0050 subjects
4 subjects
FG00515 subjects
0 subjects
FG0050 subjects
0 subjects
FG0040 subjects
FG0050 subjects
Early terminated but completed follow-up
FG00012 subjects
FG00116 subjects
FG00220 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Lost to Follow-up
FG0004 subjects
FG0012 subjects
FG0027 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Adverse Event
FG0001 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Physician Decision
FG0002 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Subject move out of town
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Subject did not come for Visit-802
FG0000 subjects
FG0010 subjects
FG0023 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
Labor Reasons
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
9
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061255
Title
Measurements
BG00047.4± 13.50
BG00145.9± 12.85
BG00249.0± 13.61
BG00340.0± 9.62
BG00446.0± 13.17
BG00546.1± 13.05
BG00647.8± 13.45
611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
Female
BG000111
BG001107
BG002199
BG0032
BG0040
BG0054
BG006423
Male
BG000199
BG001199
BG002412
BG0037
BG004
611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
Hispanic or Latino
BG00059
BG00155
BG002111
BG0030
BG0040
BG0050
BG006225
Not Hispanic or Latino
BG000243
BG001244
BG002489
BG0039
BG004
Unknown or Not Reported
BG0008
BG0017
BG00211
BG0030
BG004
611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
American Indian or Alaska Native
BG00011
BG00112
BG00223
BG0030
BG0040
BG0050
BG00646
Asian
BG00031
BG00132
BG00264
BG0039
BG004
Native Hawaiian or Other Pacific Islander
BG0000
BG0010
BG0024
BG0030
BG004
Black or African American
BG00014
BG0018
BG00222
BG0030
BG004
White
BG000251
BG001253
BG002486
BG0030
BG004
More than one race
BG0003
BG0011
BG00212
BG0030
BG004
Unknown or Not Reported
BG0000
BG0010
BG0020
BG0030
BG004
611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00014
BG00116
BG00229
BG0030
BG0040
BG0050
BG00659
Argentina
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG0009
BG0019
BG00219
BG003
Romania
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG0005
BG0015
BG0029
BG003
Hungary
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00011
BG00110
BG00223
BG003
United States
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG000119
BG001118
BG002238
BG003
Czechia
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG0003
BG0013
BG0028
BG003
Japan
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG0005
BG0012
BG0029
BG003
Canada
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00049
BG00149
BG00299
BG003
South Korea
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00011
BG00112
BG00222
BG003
Taiwan
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG0005
BG0016
BG0029
BG003
Poland
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00043
BG00143
BG00283
BG003
Mexico
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00010
BG0018
BG00217
BG003
Australia
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00014
BG00114
BG00228
BG003
Germany
ParticipantsBG000310
ParticipantsBG001306
ParticipantsBG002611
ParticipantsBG0039
ParticipantsBG0045
ParticipantsBG00516
ParticipantsBG0061257
Title
Measurements
BG00012
BG00111
BG00218
BG003
Risk Difference (RD)
1.9
2-Sided
Superiority
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000310
OG001306
OG002611
Title
Denominators
Categories
Title
Measurements
OG00079
OG00183.7
OG00285.9
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
OG002
Regression, Logistic
=0.006
Risk Difference (RD)
6.9
2-Sided
Superiority
OG000
OG001
Regression, Logistic
=0.118
Risk Difference (RD)
4.6
2-Sided
Superiority
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000310
OG001306
OG002611
Title
Denominators
Categories
Title
Measurements
OG00044.8
OG00148.7
OG00260.1
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000310
OG001306
OG002611
Title
Denominators
Categories
Title
Measurements
OG00065.2
OG00173.9
OG00279.5
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000310
OG001306
OG002611
Title
Denominators
Categories
Title
Measurements
OG00043.5
OG00149.3
OG00259.7
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000274
OG001268
OG002538
Title
Denominators
Categories
Title
Measurements
OG000-18.34± 0.22
OG001-18.95± 0.22
OG002-19.41± 0.17
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000274
OG001268
OG002538
Title
Denominators
Categories
Title
Measurements
OG00091.09± 0.89
OG00194.24± 0.90
OG00296.25± 0.71
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000274
OG001268
OG002538
Title
Denominators
Categories
Title
Measurements
OG000-23.93± 0.34
OG001-24.62± 0.34
OG002-25.01± 0.27
OG001
80 mg Ixekizumab Q4W/Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000156
OG001148
OG002314
Title
Denominators
Categories
Title
Measurements
OG000-19.27± 0.81
OG001-19.87± 0.83
OG002-20.82± 0.62
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as one SQ injection Q4W with step-up dosing to Q2W as needed (Q4W/Q2W step-up) to week 52. Placebo administered SQ, Q2W to maintain blind.
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000252
OG001245
OG002477
Title
Denominators
Categories
Title
Measurements
OG000-18.35± 0.31
OG001-18.73± 0.31
OG002-18.65± 0.24
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG00072
OG00182
OG002150
Title
Denominators
Categories
Title
Measurements
OG000-9.55± 0.31
OG001-9.37± 0.30
OG002-9.00± 0.26
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000254
OG001260
OG002505
Title
Denominators
Categories
Title
Measurements
OG00074.0
OG00172.3
OG00277.2
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000310
OG001306
OG002611
Title
Denominators
Categories
Title
Measurements
OG00066.1
OG00170.3
OG00274.0
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000273
OG001265
OG002538
Title
Denominators
Categories
Title
Measurements
OG000-9.70± 0.21
OG001-9.97± 0.22
OG002-10.23± 0.17
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000274
OG001268
OG002537
Title
Denominators
Categories
Title
Measurements
OG000-4.90± 0.13
OG001-5.15± 0.13
OG002-5.33± 0.10
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000271
OG001262
OG002532
Title
Denominators
Categories
Title
Measurements
OG000-35.50± 0.94
OG001-36.77± 0.96
OG002-38.07± 0.74
OG002
80 mg Ixekizumab Q2W
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.
Units
Counts
Participants
OG000268
OG001264
OG002519
Title
Denominators
Categories
Title
Measurements
OG00011.93± 0.94
OG00112.47± 0.95
OG00214.42± 0.74
OG003
80 mg Ixekizumab Q2W Continuous
160 mg ixekizumab given as 2 SQ injections at baseline and then 80 mg ixekizumab given as 1 SQ injection Q2W to week 52. Placebo administered SQ, Q2W to maintain blind.