A Study of Ixekizumab (LY2439821) in Participants With Ac... | NCT02349295 | Trialant
NCT02349295
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jul 1, 2020Actual
Enrollment
363Actual
Phase
Phase 3
Conditions
Psoriatic Arthritis
Interventions
Placebo
Ixekizumab 80 mg Q4W
Ixekizumab 80 mg Q2W
Countries
United States
Australia
Czechia
France
Germany
Italy
Poland
Spain
Taiwan
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02349295
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
14310
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBE
Other Identifier
Eli Lilly and Company
2011-002328-42
EudraCT Number
Brief Title
A Study of Ixekizumab (LY2439821) in Participants With Active Psoriatic Arthritis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo Controlled 24-Week Study Followed by Long Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in Biologic Disease-Modifying Antirheumatic Drug-Experienced Patients With Active Psoriatic Arthritis
Acronym
SPIRIT-P2
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Sep 1, 2019
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
Dec 31, 2014Actual
Primary Completion Date
Sep 9, 2016Actual
Completion Date
Jun 26, 2019Actual
First Submitted Date
Oct 10, 2014
First Submission Date that Met QC Criteria
Jan 23, 2015
First Posted Date
Jan 28, 2015Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 6, 2017
Results First Submitted that Met QC Criteria
Nov 17, 2017
Results First Posted Date
Dec 14, 2017Actual
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 19, 2020
Last Update Posted Date
Jul 1, 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)
Yes
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 how effective and safe the study drug known as ixekizumab is in participants with active psoriatic arthritis.
Detailed Description
Not provided
Conditions Module
Conditions
Psoriatic Arthritis
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
363Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)
Experimental
Blinded Treatment Period (Week(wk) 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22, and 24.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Wks 16,18,20,22,24. Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q2W at week 0 and continued on ixe 80 mg Q2W during the Extension Period. Pts who received ixekizumab 80 mg Q2W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Drug: Placebo
Drug: Ixekizumab 80 mg Q2W
Ixekizumab 80 mg Q4W
Experimental
Blinded Treatment Period (Week 0-24): Participants (pts) received a starting dose of 160 mg of ixekizumab (ixe) given as 2 subcutaneous (SC) injections at Wk 0 followed by 1 SC injection of 80 mg of ixe Q4W given on Wks 4, 8 and 12 alternating with placebo for ixe injections Q4W given on Wks 2,6,10,14,18, and 22.Week 16 inadequate responders (IR) from the placebo treatment group who were re-randomized (1:1) to ixe 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Pts receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Wks 16 and 20 alternating with placebo for ixe injections Q4W given on Wks 18 and 22.Extension Period (Wk24-156):Pts who were randomized to ixe 80 mg Q4W at week 0 and continued on ixe 80 mg Q4W during the Extension Period.Pts who received ixekizumab 80 mg Q4W,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Drug: Placebo
Drug: Ixekizumab 80 mg Q4W
Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Placebo
Drug
Administered SC
Ixekizumab 80 mg Q4W
Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)
Placebo
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
Week 24
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Presents with established diagnosis of active psoriatic arthritis (PsA) for at least 6 months, and currently meets Classification for Psoriatic Arthritis (CASPAR) criteria
Active PsA defined as the presence of at least 3 tender and at least 3 swollen joints
Presence of active psoriatic skin lesion or a history of plaque psoriasis (Ps)
Men must agree to use a reliable method of birth control or remain abstinent during the study
Women must agree to use reliable birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Have been treated with 1 or more conventional disease-modifying antirheumatic drugs (cDMARDs)
Have had prior treatment with at least 1 and not more than 2 tumor necrosis factor (TNF) inhibitors. The participant must have discontinued at least 1 TNF inhibitor due to either an inadequate response (based on a minimum of 12 weeks on therapy) or documented intolerance.
Exclusion Criteria:
Current use of biologic agents for treatment of Ps or PsA
Inadequate response to greater than 2 biologic DMARDs
Current use of more than one cDMARDs
Diagnosis of active inflammatory arthritic syndromes or spondyloarthropathies other than PsA
Have received treatment with interleukin (IL) -17 or IL12/23 targeted monoclonal antibody (MAb) therapy
Serious disorder or illness other than psoriatic arthritis
Serious infection within the last 3 months
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)
Kristensen LE, McGonagle D, Rudwaleit M, Kameda H, Wurtzen PA, Ngantcha M, Holzkamper T, Smolen J. Synergistic Improvements in Synovitis, Enthesitis, and Patient-Reported Outcomes for Patients with Psoriatic Arthritis Treated with Ixekizumab in SPIRIT Trials. Rheumatol Ther. 2025 Apr;12(2):381-395. doi: 10.1007/s40744-025-00748-8. Epub 2025 Feb 27.
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 european union (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.
Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.
Blinded Treatment Period (Wk 0-24): Pts received placebo for Ixe as 2 SC injections followed by 1 SC injection Q2W given on Wks 2,4,6,8,10,12,14,16,18,20,22 and 24. Pts initially randomized to placebo treatment group in the double blind treatment period,flagged as IR at Wk 16,re-randomized to ixe 80 mg Q2W/Q4W for the remainder of the current period and following period. Extended Treatment Period (Wk 24-156): Pts who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W/Q4W during the Extension Period.Pts who remained on placebo at the completion of the double blind treatment period received the first dose of ixe (160 mg starting dose) at Wk 24.Pts who were IRs at Wk 16 and were re-randomized to ixe at Wk 16 received the first dose of ixe (160 mg starting dose) at Wk 16. Pts who received placebo,who were either completed the study or discontinued the study early entered the post-treatment follow-up period (12-24 weeks).
Drug: Placebo
Ixekizumab 80 mg Q4W
Drug
Administered SC
Ixekizumab 80 mg Q4W
LY2439821
Ixekizumab 80 mg Q2W
Drug
Administered SC
Ixekizumab 80 milligram (mg) every 2 Weeks (Q2W)
LY2439821
Baseline, Week 24
Percentage of Participants Achieving ACR20
ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Week 12
Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Week 24
Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Week 24
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.
Week 12
Percentage of Patients Achieving Minimal Disease Activity (MDA)
It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.
Week 24
Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)
The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.
Week 24
Change From Baseline in Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 12
Change From Baseline in Tender Joint Count (TJC)
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in Swollen Joint Count (SJC)
SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in Patients Global Assessment of Disease Activity VAS
The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in Physicians Global Assessment of Disease Activity VAS
The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in C-Reactive Protein (CRP)
C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score
The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
Baseline, Week 24
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Number of participants with positive treatment emergent anti-ixekizumab antibodies was summarized by treatment group.
Week 24
Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab
The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.
All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab
The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).
All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
Percentage of Participants Achieving ACR 20
ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Week 52 and Week 156
Percentage of Participants Achieving ACR 50
ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Week 52 and Week 156
Percentage of Participants Achieving ACR 70
ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
Week 52 and Week 156
Glendale
Arizona
85304
United States
Arizona Arthritis & Rheumatology Research, PLLC
Mesa
Arizona
85210
United States
Arizona Arthritis & Rheumatology Research
Phoenix
Arizona
85032
United States
Little Rock Diagnostic Clinic
Little Rock
Arkansas
72205
United States
University of California - San Diego
La Jolla
California
92093
United States
Purushotham & Akther Kotha MD Inc
La Mesa
California
91942
United States
Stanford University Hospital
Palo Alto
California
94304
United States
East Bay Rheumatology Medical Group
San Leandro
California
94578
United States
Office: Dr Robin K Dore
Tustin
California
92780
United States
Rheumatology Associates of South Florida
Boca Raton
Florida
33486
United States
Jeffrey Alper MD Research
Naples
Florida
34102
United States
Arthritis & Osteoporosis Treatment Center, PA
Orange Park
Florida
32073
United States
Florida Medical Clinic PA
Zephyrhills
Florida
33542-7505
United States
Diagnostic Rheumatology and Research
Indianapolis
Indiana
46227
United States
Physicians Clinic of Iowa
Cedar Rapids
Iowa
52403
United States
Heartland Research Associates
Wichita
Kansas
67207
United States
Bluegrass Community Research. Inc
Lexington
Kentucky
40504
United States
Johns Hopkins Arthritis Center
Baltimore
Maryland
21224
United States
Klein and Associates MD, PA
Cumberland
Maryland
21502
United States
Klein and Associates MD, PA
Hagerstown
Maryland
21740
United States
Tufts Medical Center
Boston
Massachusetts
02111
United States
Beals Institute PC
Lansing
Michigan
48917
United States
North MS Medical Clinics, Inc.
Tupelo
Mississippi
38801
United States
Washington University School of Medicine
St Louis
Missouri
63110
United States
Glacier View Research Institute
Kalispell
Montana
59901
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
New Jersey Physicians
Clifton
New Jersey
07012
United States
Atlantic Coastal Research
Toms River
New Jersey
08755
United States
Arthritis, Rheumatic & Back Disease Associates
Voorhees Township
New Jersey
08043
United States
Albuquerque Rehabilitation & Rheumatology, PC
Albuquerque
New Mexico
87102
United States
The Center for Rheumatology
Albany
New York
12203
United States
Weill Cornell Medical College
Brooklyn
New York
11201
United States
Allergy Asthma Immunology of Rochester, AAIR Research Ctr
Rochester
New York
14618
United States
Rheumatology Associates of Long Island
Smithtown
New York
11787
United States
Arthritis and Osteoporosis Consultants of the Carolinas
Charlotte
North Carolina
28207
United States
DJL Clinical Research, PLLC
Charlotte
North Carolina
28210
United States
PMG Research of Hickory, LLC
Hickory
North Carolina
28602
United States
STAT Research
Dayton
Ohio
45417
United States
Health Research Institute
Oklahoma City
Oklahoma
73103
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
PMA Medical Specialists, LLC
Limerick
Pennsylvania
19468
United States
Clinical Research Center of Reading, LLC
Wyomissing
Pennsylvania
19610
United States
Pennsylvania Regional Center for Arthritis & Osteoarthritis
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña
15006
Spain
Hospital Regional Universitario de Málaga
Málaga
29009
Spain
Hospital Universitario Nuestra Señora de Valme
Seville
46014
Spain
Chi-Mei Hospital, Liouying
Tainan
Yongkang Dist
Taiwan
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung City (r.o.c)
83301
Taiwan
Chung Shan Medical University Hospital
Taichung
40201
Taiwan
China Medical University Hospital
Taichung
40447
Taiwan
Taichung Veterans General Hospital
Taichung
40705
Taiwan
National Taiwan University Hospital
Taipei
10002
Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan City
33305
Taiwan
Basildon and Thurrock University Hospital
Basildon
Essex
SS16 5NL
United Kingdom
King George Hospital
Goodmayes
Essex
IG7 4DY
United Kingdom
Princess Alexandra Hospital
Harlow
Essex
CM20 1QX
United Kingdom
Whipps Cross University Hospital
London
Surrey
E11 1NR
United Kingdom
New Cross Hospital
Wolverhampton
West Midlands
WV10 0QP
United Kingdom
Chapel Allerton Hospital
Leeds
West Yorkshire
LS7 4SA
United Kingdom
Derived
Tillett W, Birt J, Vadhariya A, Ross S, Ngantcha M, Ng KJ. Filling the "GAP" in Real-World Assessment of Psoriatic Arthritis Disease Activity: Performance Characteristics of a Global/Pain Composite Endpoint. Rheumatol Ther. 2024 Oct;11(5):1101-1114. doi: 10.1007/s40744-024-00690-1. Epub 2024 Jul 2.
Armstrong AW, Jaleel T, Merola JF, Gottlieb AB, Khattri S, Helt CC, Malatestinic WN, Ross SE, Ngantcha ME, de Vlam K. Ixekizumab Demonstrates Rapid and Consistent Efficacy for Patients with Psoriatic Arthritis, Regardless of Psoriasis Severity. Dermatol Ther (Heidelb). 2024 Jun;14(6):1615-1631. doi: 10.1007/s13555-024-01188-y. Epub 2024 May 30.
Kirkham BW, Egeberg A, Behrens F, Pinter A, Merola JF, Holzkamper T, Gallo G, Ng KJ, Bolce R, Schuster C, Nash P, Puig L. A Comprehensive Review of Ixekizumab Efficacy in Nail Psoriasis from Clinical Trials for Moderate-to-Severe Psoriasis and Psoriatic Arthritis. Rheumatol Ther. 2023 Oct;10(5):1127-1146. doi: 10.1007/s40744-023-00553-1. Epub 2023 Jul 3.
Eder L, Tony HP, Odhav S, Agirregoikoa EG, Korkosz M, Schwartzman S, Sprabery AT, Gellett AM, Park SY, Bertram CC, Ogdie A. Responses to Ixekizumab in Male and Female Patients with Psoriatic Arthritis: Results from Two Randomized, Phase 3 Clinical Trials. Rheumatol Ther. 2022 Jun;9(3):919-933. doi: 10.1007/s40744-022-00445-w. Epub 2022 Apr 9.
Deodhar AA, Combe B, Accioly AP, Bolce R, Zhu D, Gellett AM, Sprabery AT, Burmester GR. Safety of ixekizumab in patients with psoriatic arthritis: data from four clinical trials with over 2000 patient-years of exposure. Ann Rheum Dis. 2022 Jul;81(7):944-950. doi: 10.1136/annrheumdis-2021-222027. Epub 2022 Apr 7.
Combe B, Tsai TF, Huffstutter JE, Sprabery AT, Lin CY, Park SY, Kronbergs A, Hufford MM, Nash P. Ixekizumab, with or without concomitant methotrexate, improves signs and symptoms of PsA: week 52 results from Spirit-P1 and Spirit-P2 studies. Arthritis Res Ther. 2021 Jan 27;23(1):41. doi: 10.1186/s13075-020-02388-5.
Orbai AM, Gratacos J, Turkiewicz A, Hall S, Dokoupilova E, Combe B, Nash P, Gallo G, Bertram CC, Gellett AM, Sprabery AT, Birt J, Macpherson L, Geneus VJ, Constantin A. Efficacy and Safety of Ixekizumab in Patients with Psoriatic Arthritis and Inadequate Response to TNF Inhibitors: 3-Year Follow-Up (SPIRIT-P2). Rheumatol Ther. 2021 Mar;8(1):199-217. doi: 10.1007/s40744-020-00261-0. Epub 2020 Dec 5.
Schweikert B, Malmberg C, Nunez M, Dilla T, Sapin C, Hartz S. Cost-effectiveness analysis of ixekizumab versus secukinumab in patients with psoriatic arthritis and concomitant moderate-to-severe psoriasis in Spain. BMJ Open. 2020 Aug 13;10(8):e032552. doi: 10.1136/bmjopen-2019-032552.
Combe B, Rahman P, Kameda H, Canete JD, Gallo G, Agada N, Xu W, Genovese MC. Safety results of ixekizumab with 1822.2 patient-years of exposure: an integrated analysis of 3 clinical trials in adult patients with psoriatic arthritis. Arthritis Res Ther. 2020 Jan 21;22(1):14. doi: 10.1186/s13075-020-2099-0.
Tillett W, Lin CY, Zbrozek A, Sprabery AT, Birt J. A Threshold of Meaning for Work Disability Improvement in Psoriatic Arthritis Measured by the Work Productivity and Activity Impairment Questionnaire. Rheumatol Ther. 2019 Sep;6(3):379-391. doi: 10.1007/s40744-019-0155-5. Epub 2019 Jun 1.
Coates LC, Orbai AM, Morita A, Benichou O, Kerr L, Adams DH, Shuler CL, Birt J, Helliwell PS. Achieving minimal disease activity in psoriatic arthritis predicts meaningful improvements in patients' health-related quality of life and productivity. BMC Rheumatol. 2018 Aug 13;2:24. doi: 10.1186/s41927-018-0030-y. eCollection 2018.
Gladman DD, Orbai AM, Klitz U, Wei JC, Gallo G, Birt J, Rathmann S, Shrom D, Marzo-Ortega H. Ixekizumab and complete resolution of enthesitis and dactylitis: integrated analysis of two phase 3 randomized trials in psoriatic arthritis. Arthritis Res Ther. 2019 Jan 29;21(1):38. doi: 10.1186/s13075-019-1831-0.
Genovese MC, Combe B, Kremer JM, Tsai TF, Behrens F, Adams DH, Lee C, Kerr L, Nash P. Safety and efficacy of ixekizumab in patients with PsA and previous inadequate response to TNF inhibitors: week 52 results from SPIRIT-P2. Rheumatology (Oxford). 2018 Nov 1;57(11):2001-2011. doi: 10.1093/rheumatology/key182.
Nash P, Kirkham B, Okada M, Rahman P, Combe B, Burmester GR, Adams DH, Kerr L, Lee C, Shuler CL, Genovese M; SPIRIT-P2 Study Group. Ixekizumab for the treatment of patients with active psoriatic arthritis and an inadequate response to tumour necrosis factor inhibitors: results from the 24-week randomised, double-blind, placebo-controlled period of the SPIRIT-P2 phase 3 trial. Lancet. 2017 Jun 10;389(10086):2317-2327. doi: 10.1016/S0140-6736(17)31429-0. Epub 2017 May 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
FG002
Placebo (PBO) - Blinded Treatment Period
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
FG003
Ixe 80 mg Q2W - Blinded Treatment Period IR
Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
FG004
Ixe 80 mg Q4W - Blinded Treatment Period IR
Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Participants received rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
FG005
PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR
Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.
FG006
PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR
Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders at week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.
Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
FG009
Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
FG010
Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
FG011
Ixe 80 mg Q2W - Post Treatment Follow-Up Period
Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
FG012
Ixe 80 mg Q4W - Post Treatment Follow-Up Period
Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
FG013
PBO - Post Treatment Follow-Up Period
Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
FG000123 subjects
FG001122 subjects
FG002118 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Received Atleast One Dose of Study Drug
FG000123 subjects
FG001122 subjects
FG002118 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG000109 subjects
FG001111 subjects
FG00294 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
NOT COMPLETED
FG00014 subjects
FG00111 subjects
FG00224 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Type
Comment
Reasons
Adverse Event
FG0007 subjects
FG0015 subjects
FG0025 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Lack of Efficacy
FG0004 subjects
FG0012 subjects
FG0029 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0002 subjects
FG0012 subjects
FG0027 subjects
FG0030 subjects
FG004
Lost to Follow-up
FG0001 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Failure To Meet Randomization
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0030 subjects
FG004
IR (Week 16-24)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsOnly IR participants were included.
FG0010 subjectsOnly IR participants were included.
FG0020 subjectsOnly IR participants were included.
FG00317 subjectsIR from ixekizumab 80 mg Q2W only.
FG00415 subjectsIR from ixekizumab 80 mg Q4W only.
FG00516 subjectsIR from placebo who re-randomized (1:1) to ixekizumab 80 mg Q2W.
FG00616 subjectsIR from placebo who re-randomized (1:1) to ixekizumab 80 mg Q4W.
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00316 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Long-Term Extension Period (Week 24-156)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsOnly included combined extension participants.
FG0040 subjectsOnly included combined extension participants.
FG0050 subjectsOnly included combined extension participants.
FG0060 subjectsOnly included combined extension participants.
FG007107 subjectsIxeQ2W participants who entered the long-term extension period.
FG008111 subjectsIxeQ4W participants who entered the long-term extension period.
FG00946 subjectsPlacebo/IxeQ2W participants who entered the long-term extension period.
FG01046 subjectsPlacebo/IxeQ4W participants who entered the long-term extension period.
FG0110 subjects
FG0120 subjects
FG0130 subjects
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-Up Period (Up to 12-24 Weeks)
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjectsOnly included post-treatment follow-up participants.
FG0080 subjectsOnly included post-treatment follow-up participants.
FG0090 subjectsOnly included post-treatment follow-up participants.
FG0100 subjectsOnly included post-treatment follow-up participants.
FG011142 subjectsIxeQ2W participants who entered post-treatment follow-up.
FG012145 subjectsIxeQ4W participants who entered post-treatment follow-up.
FG01317 subjectsPBO participants who entered post-treatment follow-up.
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
All randomized participants.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
BG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
BG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000118
BG001122
BG002123
BG003363
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
years
Title
Denominators
Categories
Title
Measurements
BG00051.5± 10.39
BG00152.6± 13.57
BG00251.7± 11.85
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00062
BG00159
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG00111
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0000
BG0010
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Czechia
Title
Measurements
BG0008
BG0014
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving American College of Rheumatology 20 Index (ACR20)
ACR20 response is defined as a greater than or equal to (≥) 20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain visual analog scale (VAS), Participant's Global Assessment of Disease Activity VAS (PatGA), Physician's Global Assessment of the Disease Activity VAS (PGA), Participant's Assessment of Physical Function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or Acute Phase Reactant as measured by high sensitivity C-reactive protein (hs-CRP).
All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG00019.5
OG00153.3
OG00248.0
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
1) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.
<0.001
model includes: treatment, geographic region, and tumor necrosis factor inhibitor (TNFi) experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi).
Odds Ratio (OR)
4.74
2-Sided
95
2.65
8.48
Other
Secondary
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score
HAQ-DI is a participant reported questionnaire that measures disease-associated disability(physical function).It consists of 24 questions with 8 domains: dressing/grooming,arising,eating,walking,hygiene,reach,grip and other daily activities. The disability section scores the participant's self-perception on degree of difficulty (0=without any difficulty,1=with some difficulty,2=with much difficulty,3=unable to do)covering the 8 domains.The HAQ-DI is a composite ranging from 0-3 with lower scores indicating less functional disability.The reported use of special aids/devices and/or the need for assistance of another person to perform these activities is assessed.Least Square (LS) mean calculated using Mixed Model Repeated Measurements (MMRM) analysis with treatment,baseline score,geographic region, TNFi experience,visit, treatment-by-visit interaction(itcn), geographic region-by-visit itcn,TNFi experience-by-visit itcn and baseline score-by-visit itcn.
All randomized participants.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Secondary
Percentage of Participants Achieving ACR20
ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Percentage of Participants Achieving American College of Rheumatology 50 Index (ACR50)
ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Percentage of Participants Achieving American College of Rheumatology 70 Index (ACR70)
ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Percentage of Participants With Psoriasis Area and Severity Index (PASI) 75
The PASI is an index that combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 for no psoriasis to 72 for the most severe disease. Participants achieving PASI 75 were defined as having an improvement of at least 75% in the PASI compared to their baseline measures.
All randomized participants with baseline psoriatic lesion(s) involving ≥3% body surface area (BSA). NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Percentage of Patients Achieving Minimal Disease Activity (MDA)
It uses a composite of 7 key outcome measures (includes PASI) used in PsA to encompass all of the domains of the disease to measure the overall state of a patients' disease. The LEI is used to assess tender entheseal points. Patients are classified as achieving MDA if they fulfill 5 of 7 outcome measures: 1. TJC ≤1, 2. SJC ≤1, 3. PASI total score ≤1 or BSA ≤3, 4. patient pain VAS score of ≤15, 5. patient global VAS score of ≤20, 6. HAQ-DI score ≤0.5, 7. tender entheseal points (6 entheseal points) ≤1.
All randomized participants. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Percentage of Patients Achieving Complete Resolution in Enthesitis as Assessed by the Leeds Enthesitis Index (LEI)
The LEI was developed specifically for use in PsA. It measures enthesitis at 6 sites (lateral epicondyle, left and right; medial femoral condyle, left and right; Achilles tendon insertion, left and right). Each site was assigned a score of 0 (absent) or 1 (present); the results from each site were then added to produce a total score (range 0 to 6). So, "0" indicates good score here.
All randomized participants who had baseline enthesitis, baseline LEI score and post baseline LEI score data. NRI is applied for inadequate responders at Week 16 and participants who had missing data at Week 24 for any reason including discontinuation.
Posted
Number
Percentage of Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Change From Baseline in Itch Numeric Rating Scale (NRS)
The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no itch" and 10 representing "worst itch imaginable." Overall severity of a participants itching from psoriasis was indicated by circling the number that best described the worst level of itching in the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants who had baseline psoriatic lesion(s) involving >=3% BSA, baseline itch NRS score and post baseline itch NRS score data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 12
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Secondary
Change From Baseline in Tender Joint Count (TJC)
TJC is the number of tender and painful joints determined for each participant by examination of 68 joints. Joints were assessed by pressure and joint manipulation on physical examination. Participants were asked for pain sensations on these manipulations and watched for spontaneous pain reactions. Any positive response on pressure, movement, or both was translated into a single tender-versus-nontender dichotomy. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants with baseline and post baseline TJC data.
Posted
Least Squares Mean
Standard Error
Tender Joint Count
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Secondary
Change From Baseline in Swollen Joint Count (SJC)
SJC is the number of swollen joints determined for each participant by examination of 66 joints. Joints were classified as either swollen or not swollen. Swelling was defined as palpable fluctuating synovitis of the joint. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants with baseline and post baseline SJC data.
Posted
Least Squares Mean
Standard Error
Swollen Joint Count
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Change From Baseline in Participants Assessment of Pain Visual Analog Scale (VAS)
The pain VAS is a participant-administered single-item scale designed to measure current joint pain from Psoriatic arthritis (PsA) using a 100-millimeter(mm) horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by marking a vertical tick on the horizontal 100-mm scale, where the left end from 0 mm (no pain) to right end 100 mm (worst possible joint pain). LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants with baseline and post baseline TJC and SJC data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Secondary
Change From Baseline in Patients Global Assessment of Disease Activity VAS
The patient's overall assessment of his or her PsA activity will be recorded using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants with baseline and post baseline Patients Global Assessment of Disease Activity VAS score.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Change From Baseline in Physicians Global Assessment of Disease Activity VAS
The investigator will be asked to give an overall assessment of the severity of the participant's current PsA activity using a 100-mm horizontal VAS, where 0 represents no disease activity and 100 represents extremely active disease. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants with baseline and post baseline Physicians Global Assessment of Disease Activity VAS score.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Change From Baseline in C-Reactive Protein (CRP)
C-reactive protein (CRP) is a disease related biomarker and measured in milligrams per liter. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants with baseline and post baseline CRP data.
Posted
Least Squares Mean
Standard Error
milligram per liter (mg/L)
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Change From Baseline in Disease Activity Score-CRP (DAS28-CRP)
The DAS28-CRP is a measure of disease activity in 28 joints that consists of a composite numerical score with the following variables: TJC28, SJC28, hs-CRP (measured in mg/L), and Participant's Global Assessment of Disease Activity recorded by participants on a 0 to 100 millimeter (mm) VAS. For DAS28-CRP, the Tender Joint Count 28 (TJC28) and Swollen Joint Count (SJC28) are a subset of TJC and SJC, and include 14 joints on each side of the body: 2 shoulders, 2 elbows, 2 wrists, 10 metacarpophalangeal joints, the 2 interphalangeal joints of the thumb, the 8 proximal interphalangeal joints, and the 2 knees. DAS28 values range from 0 to 9.4. Higher values indicate more severe symptoms and greater functional impairment. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants who had baseline and post baseline DAS28-CRP data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Secondary
Change From Baseline in the Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) Score
The BASDAI is a self-administered measure used to answer 6 questions with a 0 to 10 centimeter (cm) VAS pertaining to the 5 major symptoms of axial activity. To give each symptom equal weighting, the mean of the 2 scores relating to morning stiffness was taken. The resulting 0 to 50 score was divided by 5 to give a final 0 to 10 BASDAI Score. BASDAI ranges from 0-10. Higher scores represent greater disease activity. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants who had baseline axial involvement defined as baseline BASDAI score >4, baseline BASDAI score and post baseline BASDAI score data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Secondary
Change From Baseline in Fatigue Severity Numeric Rating Scale (NRS) Score
The Fatigue Severity NRS is a participant-administered single-item 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine." Participants rated their fatigue (feeling tired or worn out) by circling the 1 number that described their worst level of fatigue during the past 24 hours. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants who had baseline and post baseline fatigue NRS data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Physical Component Summary (PCS)
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants who had baseline and post baseline PCS data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Secondary
Change From Baseline in 36-Item Short-Form Health Survey (SF-36) Scores: Mental Component Summary (MCS)
The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. In this study, the SF-36 acute version was used, which has a 1 week recall period. LS mean was calculated using MMRM analysis with treatment, baseline score, geographic region, TNFi experience, visit, treatment-by-visit interaction, geographic region-by-visit interaction, TNFi experience-by-visit interaction, and baseline score-by-visit interaction.
All randomized participants who had baseline and post baseline MCS data.
Posted
Least Squares Mean
Standard Error
Units on a Scale
Baseline, Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Secondary
Number of Participants With Treatment Emergent Anti-Drug Antibodies (TE-ADA)
Number of participants with positive treatment emergent 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.
Posted
Number
Participants
Week 24
ID
Title
Description
OG000
Placebo
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy and re-randomized (1:1) to either ixekizumab group, receiving a starting dose of 160 mg at Week 16 given as 2 SC injections followed by 80 mg given as 1 injection according to ixekizumab regimen: Q2W or Q4W (with placebo every other dose). All other participants continue placebo as 1 injection Q2W given on Weeks 16, 18, 20 and 22
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
Secondary
Pharmacokinetics (PK):Minimum Observed Serum Concentration at Steady State (Ctrough,ss) of Ixekizumab
The Ctrough is the minimum observed serum concentration at steady state of Ixekizumab. The Ctrough at Week 24 was reported.
The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
micograms per milliliter (mcg/mL)
All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
ID
Title
Description
OG000
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG001
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Secondary
Pharmacokinetics: Area Under the Concentration-Time Curve for Dosing Interval (Tau) at Steady State [AUC(Tau,Steady State)] of Ixekizumab
The AUC(Tau,Steady State) is the area under the concentration-time curve for dosing interval (Tau) at steady state of ixekizumab (Tau is 28 days for 80 mg Q4W cohort, and is 14 days for 80mg Q2W cohort, respectively).
The PK Population included all enrolled participants who received at least one dose of the study drug and had evaluable ixekizumab PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
mcg*day/mL
All immunogenicity samples post the first Ixekizumab dose (Week 4, 12, 24, 36, and 52) and PK samples collected per dedicated sparse sampling plan (4-5 samples per patient) across Weeks 1 through 24 and Early termination visit (ETV)
ID
Title
Description
OG000
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG001
Ixekizumab 80 mg Q2W
Secondary
Percentage of Participants Achieving ACR 20
ACR20 response is defined as a ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.
Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
OG002
Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Secondary
Percentage of Participants Achieving ACR 50
ACR50 response is defined as a ≥50% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.
Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
OG002
Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Secondary
Percentage of Participants Achieving ACR 70
ACR70 response is defined as a ≥70% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: Participant's assessment of Joint Pain VAS, Participant's Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, Participant's Assessment of Physical Function using the HAQ-DI, or hs-CRP.
All randomized participants. Non-responder Imputation (NRI) is applied for inadequate responders at week 16 and participants who discontinued on or prior to week 24.
Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
OG002
Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Time Frame
Baseline Up To 2.55 Years
Description
All randomized participants who received at least one dose of study drug. The gender specific events only occurring in male or female participants were adjusted accordingly.
Participants received a starting dose of 160 mg of ixekizumab given as 2 subcutaneous (SC) injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab every 2 Weeks (Q2W) given on Weeks 2, 4, 6, 8, 10, 12,14, 16, 18, 20, 22, and 24.
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14, 18, and 22.
3
122
58
122
EG002
Placebo (PBO) - Blinded Treatment Period
Participants received placebo for ixekizumab as 2 SC injections followed by 1 SC injection Q2W given on Weeks 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, and 24.
4
118
40
118
EG003
Ixe 80 mg Q2W - Blinded Treatment Period IR
Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q2W and IR from ixekizumab 80 mg Q2W who continued on ixekizumab 80 mg Q2W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20, 22, and 24.
0
17
5
17
EG004
Ixe 80 mg Q4W - Blinded Treatment Period IR
Week 16 inadequate responders from the placebo treatment group who were re-randomized (1:1) to ixekizumab 80 mg Q4W and IR from ixekizumab 80 mg Q4W who continued on ixekizumab 80 mg Q4W. Patients receive rescue therapy while receiving ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22.
0
15
8
15
EG005
PBO IR / Ixe 80 mg Q2W - Blinded Treatment Period IR
Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q2W for the remainder of the current period and following period.
0
16
11
16
EG006
PBO IR / Ixe 80 mg Q4W - Blinded Treatment Period IR
Participants initially randomized to placebo treatment group in the double blind treatment period who were flagged as inadequate responders as week 16 were re-randomized to ixekizumab 80 mg Q4W for the remainder of the current period and following period.
Participants who were randomized to ixekizumab 80 mg Q4W at week 0 and continued on ixekizumab 80 mg Q4W during the Extension Period.
13
111
65
111
EG009
Placebo/ Ixe 80 mg Q2W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q2W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
6
46
20
46
EG010
Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
3
46
32
46
EG011
Ixe 80 mg Q2W - Post Treatment Follow-Up Period
Participants who received ixekizumab 80 mg Q2W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
1
142
16
142
EG012
Ixe 80 mg Q4W - Post Treatment Follow-Up Period
Participants who received ixekizumab 80 mg Q4W prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
2
145
13
145
EG013
PBO - Post Treatment Follow-Up Period
Participants who received PBO prior to entering the post-treatment follow-up period, who were either completed the study or discontinued the study early entered the post-treatment follow-up period (a 12-24 week period after their last scheduled treatment visit).
2
17
2
17
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Iron deficiency anaemia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG0030 events0 affected17 at risk
EG004
Acute coronary syndrome
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Arteriosclerosis coronary artery
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Cardio-respiratory arrest
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Coronary artery thrombosis
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Myocardial ischaemia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Vertigo
Ear and labyrinth disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Basedow's disease
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Retinal detachment
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Abdominal pain
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Anal fistula
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Colitis ischaemic
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Gastrooesophageal reflux disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Nausea
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Vomiting
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Cholelithiasis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Hepatic cirrhosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Abscess jaw
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Anal abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Diverticulitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Latent tuberculosis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Lower respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Oesophageal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Oral candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Osteomyelitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Perirectal abscess
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Postoperative wound infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Fall
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Femoral neck fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Foot fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Postoperative wound complication
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Tendon rupture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Diabetes mellitus
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Myofascial pain syndrome
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Gastrointestinal stromal tumour
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Malignant melanoma in situ
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Metastatic renal cell carcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Papillary thyroid cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Prostate cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected50 at risk
EG0011 events1 affected63 at risk
EG0020 events0 affected56 at risk
EG003
Cerebrovascular accident
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Cervicobrachial syndrome
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Haemorrhagic stroke
Nervous system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Abortion spontaneous
Pregnancy, puerperium and perinatal conditions
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected59 at risk
EG0020 events0 affected62 at risk
EG003
Depression
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Adnexa uteri cyst
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected73 at risk
EG0010 events0 affected59 at risk
EG0021 events1 affected62 at risk
EG003
Uterine prolapse
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected73 at risk
EG0010 events0 affected59 at risk
EG0020 events0 affected62 at risk
EG003
Asthma
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Bronchospasm
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Dyspnoea
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Psoriasis
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Coronary arterial stent insertion
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Knee arthroplasty
Surgical and medical procedures
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Peripheral arterial occlusive disease
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenopathy
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG0030 events0 affected17 at risk
EG0040 events0 affected15 at risk
EG0051 events1 affected16 at risk
EG0060 events0 affected16 at risk
EG0072 events2 affected107 at risk
EG0080 events0 affected111 at risk
EG0090 events0 affected46 at risk
EG0101 events1 affected46 at risk
EG0110 events0 affected142 at risk
EG0120 events0 affected145 at risk
EG0130 events0 affected17 at risk
Thrombocytopenia
Blood and lymphatic system disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Goitre
Endocrine disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Entropion
Eye disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Dental caries
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Gastritis
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Haemorrhoids
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Mouth ulceration
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Rectal haemorrhage
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Asthenia
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Influenza like illness
General disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Injection site erythema
General disorders
MedDRA 22.0
Systematic Assessment
EG00020 events4 affected123 at risk
EG0014 events3 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Injection site induration
General disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Injection site pain
General disorders
MedDRA 22.0
Systematic Assessment
EG0006 events2 affected123 at risk
EG0011 events1 affected122 at risk
EG0024 events2 affected118 at risk
EG003
Injection site reaction
General disorders
MedDRA 22.0
Systematic Assessment
EG00047 events15 affected123 at risk
EG00120 events6 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Injection site swelling
General disorders
MedDRA 22.0
Systematic Assessment
EG00015 events2 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Hepatic steatosis
Hepatobiliary disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Bronchitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected123 at risk
EG0012 events1 affected122 at risk
EG0024 events4 affected118 at risk
EG003
Cystitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Ear infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Influenza
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0012 events2 affected122 at risk
EG0022 events1 affected118 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected123 at risk
EG00111 events9 affected122 at risk
EG0024 events4 affected118 at risk
EG003
Otitis externa
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0012 events2 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Otitis media
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected123 at risk
EG0011 events1 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0012 events2 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0007 events5 affected123 at risk
EG0017 events7 affected122 at risk
EG0022 events2 affected118 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0014 events4 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG00012 events12 affected123 at risk
EG00114 events12 affected122 at risk
EG00212 events9 affected118 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0004 events4 affected123 at risk
EG00111 events6 affected122 at risk
EG0023 events3 affected118 at risk
EG003
Vulvovaginal candidiasis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected73 at risk
EG0010 events0 affected59 at risk
EG0020 events0 affected62 at risk
EG003
Vulvovaginal mycotic infection
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected73 at risk
EG0011 events1 affected59 at risk
EG0021 events1 affected62 at risk
EG003
Exposure to toxic agent
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Alanine aminotransferase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0002 events2 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Blood bilirubin increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Hepatic enzyme increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Hyperuricaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0015 events5 affected122 at risk
EG0022 events2 affected118 at risk
EG003
Muscle spasms
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0010 events0 affected122 at risk
EG0022 events2 affected118 at risk
EG003
Psoriatic arthropathy
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected123 at risk
EG0013 events3 affected122 at risk
EG0028 events8 affected118 at risk
EG003
Sleep terror
Psychiatric disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Benign prostatic hyperplasia
Reproductive system and breast disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected50 at risk
EG0010 events0 affected63 at risk
EG0020 events0 affected56 at risk
EG003
Cough
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0005 events4 affected123 at risk
EG0015 events4 affected122 at risk
EG0023 events3 affected118 at risk
EG003
Oropharyngeal pain
Respiratory, thoracic and mediastinal disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0017 events7 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Alopecia
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0003 events3 affected123 at risk
EG0010 events0 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Erythema
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected123 at risk
EG0013 events3 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Night sweats
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0020 events0 affected118 at risk
EG003
Pruritus generalised
Skin and subcutaneous tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected123 at risk
EG0011 events1 affected122 at risk
EG0021 events1 affected118 at risk
EG003
Hypertension
Vascular disorders
MedDRA 22.0
Systematic Assessment
EG0006 events6 affected123 at risk
EG0013 events2 affected122 at risk
EG0023 events3 affected118 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
ClinicalTrials.gov@lilly.com
ID
Term
D015535
Arthritis, Psoriatic
Ancestor Terms
ID
Term
D025242
Spondylarthropathies
D025241
Spondylarthritis
D013166
Spondylitis
D013122
Spinal Diseases
D001847
Bone Diseases
D009140
Musculoskeletal Diseases
D001168
Arthritis
D007592
Joint Diseases
D011565
Psoriasis
D017444
Skin Diseases, Papulosquamous
D012871
Skin Diseases
D017437
Skin and Connective Tissue Diseases
Browse Leaves
Not provided
Browse Branches
Not provided
ID
Term
C549079
ixekizumab
Ancestor Terms
Not provided
Browse Leaves
Not provided
Browse Branches
Not provided
0 subjects
FG0050 subjects
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0 subjects
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0 subjects
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0 subjects
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15 subjects
FG00516 subjects
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FG0070 subjects
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0 subjects
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1 subjects
FG0040 subjects
FG0050 subjects
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0 subjects
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FG00755 subjects
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0 subjects
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FG00752 subjects
FG00841 subjects
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0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG00732 subjects
FG00825 subjects
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FG01018 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
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FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0079 subjects
FG0089 subjects
FG0092 subjects
FG0102 subjects
FG0110 subjects
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Unknown/Missing
FG0000 subjects
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FG0030 subjects
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FG0060 subjects
FG0072 subjects
FG0080 subjects
FG0093 subjects
FG0100 subjects
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Death
FG0000 subjects
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FG0071 subjects
FG0081 subjects
FG0091 subjects
FG0100 subjects
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Withdrawal by Subject
FG0000 subjects
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FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0074 subjects
FG0082 subjects
FG0091 subjects
FG0103 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0072 subjects
FG0082 subjects
FG0090 subjects
FG0100 subjects
FG0110 subjects
FG0120 subjects
FG0130 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG011133 subjects
FG012137 subjects
FG01316 subjects
0 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0119 subjects
FG0128 subjects
FG0131 subjects
0 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0125 subjects
FG0131 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0122 subjects
FG0130 subjects
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0111 subjects
FG0121 subjects
FG0130 subjects
Physician Decision
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0112 subjects
FG0120 subjects
FG0130 subjects
Unknown/Missing
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
FG0100 subjects
FG0114 subjects
FG0120 subjects
FG0130 subjects
51.9
± 12.00
73
BG003194
Male
BG00056
BG00163
BG00250
BG003169
13
BG00335
Not Hispanic or Latino
BG000106
BG001109
BG002109
BG003324
Unknown or Not Reported
BG0001
BG0012
BG0021
BG0034
0
BG0030
Asian
BG0007
BG0017
BG0027
BG00321
Native Hawaiian or Other Pacific Islander
BG0000
BG0011
BG0020
BG0031
Black or African American
BG0001
BG0011
BG0021
BG0033
White
BG000108
BG001111
BG002113
BG003332
More than one race
BG0002
BG0012
BG0021
BG0035
Unknown or Not Reported
BG0000
BG0010
BG0021
BG0031
8
BG00320
United States
Title
Measurements
BG00060
BG00165
BG00263
BG003188
Taiwan
Title
Measurements
BG0006
BG0016
BG0027
BG00319
Poland
Title
Measurements
BG0005
BG0014
BG0025
BG00314
Italy
Title
Measurements
BG0000
BG0010
BG0021
BG0031
United Kingdom
Title
Measurements
BG0005
BG0016
BG0025
BG00316
Australia
Title
Measurements
BG0002
BG0012
BG0023
BG0037
France
Title
Measurements
BG0006
BG0016
BG0025
BG00317
Germany
Title
Measurements
BG00011
BG00113
BG00212
BG00336
Spain
Title
Measurements
BG00015
BG00116
BG00214
BG00345
OG000
OG002
model includes: treatment, geographic region, and TNFi experience (inadequate responder to 1 TNFi, inadequate responder to 2 TNFi, or intolerance to a TNFi)
Regression, Logistic
<0.001
Odds Ratio (OR)
3.79
2-Sided
95
2.12
6.78
Other
1) uses a Wald's test , 2) Non-responder imputation (NRI) was used to calculate the response rates.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-0.2± 0.08
OG001-0.6± 0.07
OG002-0.4± 0.07
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG00022.0
OG00150.0
OG00248.0
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG0005.1
OG00135.2
OG00233.3
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG0000
OG00122.1
OG00212.2
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG00067
OG00168
OG00268
Title
Denominators
Categories
Title
Measurements
OG00010.4
OG00157.4
OG00261.8
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG0003.4
OG00127.9
OG00223.6
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG00069
OG00168
OG00284
Title
Denominators
Categories
Title
Measurements
OG00021.7
OG00135.3
OG00231.0
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-0.7± 0.40
OG001-3.4± 0.39
OG002-3.3± 0.39
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-6.2± 1.96
OG001-12.7± 1.87
OG002-12.5± 1.77
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-5.0± 1.05
OG001-8.5± 0.99
OG002-7.4± 0.94
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-21.4± 3.97
OG001-36.9± 3.74
OG002-33.5± 3.58
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-19.0± 3.91
OG001-40.7± 3.68
OG002-37.3± 3.53
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-18.3± 3.98
OG001-40.0± 3.85
OG002-37.9± 3.75
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-3.6± 1.87
OG001-11.8± 1.76
OG002-9.8± 1.68
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-0.8± 0.20
OG001-2.1± 0.19
OG002-1.8± 0.18
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.38
OG001-3.7± 0.36
OG002-3.6± 0.35
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG000-0.7± 0.37
OG001-2.0± 0.35
OG002-2.1± 0.34
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG0003.3± 1.36
OG0018.9± 1.29
OG0028.2± 1.23
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q4W given on Weeks 4, 8 and 12 alternating with placebo for ixekizumab injections Q4W given on Weeks 2, 6, 10 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q4W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16 and 20 alternating with placebo for ixekizumab injections Q4W given on Weeks 18 and 22
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000118
OG001122
OG002123
Title
Denominators
Categories
Title
Measurements
OG0000.9± 1.32
OG0013.6± 1.24
OG0024.0± 1.18
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000112
OG001117
OG002120
Title
Denominators
Categories
Title
Measurements
OG0001
OG0018
OG0024
Units
Counts
Participants
OG000102
OG001101
Title
Denominators
Categories
Title
Measurements
OG0002.46± 79.1
OG0017.96± 71.1
Participants received a starting dose of 160 mg of ixekizumab given as 2 SC injections at Week 0 followed by 1 SC injection of 80 mg of ixekizumab Q2W given on Weeks 2, 4, 6, 8, 10, 12 and 14. Inadequate responders at Week 16 receive rescue therapy while continuing ixekizumab given as 1 injection of 80 mg Q2W given on Weeks 16, 18, 20 and 22. All other participants continue 80 mg given as 1 injection Q2W given on Weeks 16, 18, 20 and 22
Units
Counts
Participants
OG000105
OG001100
Title
Denominators
Categories
Title
Measurements
OG000141± 59.3
OG001143± 57.5
OG003
Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Units
Counts
Participants
OG000107
OG001111
OG00246
OG00346
Title
Denominators
Categories
Week 52
Title
Measurements
OG00058.9
OG00167.6
OG00250.0
OG00360.9
Week 156
Title
Measurements
OG00042.1
OG00150.5
OG00239.1
OG003
OG003
Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.
Units
Counts
Participants
OG000107
OG001111
OG00246
OG00346
Title
Denominators
Categories
Week 52
Title
Measurements
OG00038.3
OG00145.9
OG00234.8
OG00343.5
Week 156
Title
Measurements
OG00029.0
OG00135.1
OG00226.1
OG003
OG003
Placebo/ Ixe 80 mg Q4W - Extended Treatment Period
Participants who were randomized to placebo at Week 0 then randomized to ixekizumab 80 mg Q4W during the Extension Period.
Participants who remained on placebo at the completion of the double blind treatment period received the first dose of ixekizumab (160 mg starting dose) at Week 24.
Participants who were IRs at Week 16 and were re-randomized to ixekizumab at Week 16 received the first dose of ixekizumab (160 mg starting dose) at Week 16.