A Study of Ixekizumab (LY2439821) in Participants With No... | NCT02757352 | Trialant
NCT02757352
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Mar 13, 2020Actual
Enrollment
303Actual
Phase
Phase 3
Conditions
Axial Spondyloarthritis
Interventions
Ixekizumab
Placebo
Countries
United States
Argentina
Austria
Brazil
Canada
Czechia
Finland
Germany
Japan
Mexico
Netherlands
Poland
Puerto Rico
Romania
Russia
South Korea
Protocol Section
Identification Module
NCT ID
NCT02757352
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16180
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBX
Other Identifier
Eli Lilly and Company
2015-003938-27
EudraCT Number
Brief Title
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
Official Title
A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis
Acronym
COAST-X
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Aug 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
Aug 2, 2016Actual
Primary Completion Date
Mar 1, 2019Actual
Completion Date
May 7, 2019Actual
First Submitted Date
Apr 28, 2016
First Submission Date that Met QC Criteria
Apr 28, 2016
First Posted Date
May 2, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Feb 28, 2020
Results First Submitted that Met QC Criteria
Feb 28, 2020
Results First Posted Date
Mar 13, 2020Actual
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
Feb 28, 2020
Last Update Posted Date
Mar 13, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).
Detailed Description
Not provided
Conditions Module
Conditions
Axial Spondyloarthritis
Keywords
ankylosing
nonradiographic spondyloarthritis
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
303Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Q2W Ixekizumab
Experimental
Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52 during the double-blind period.
Inadequate responders (IR) as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.
Drug: Ixekizumab
Q4W Ixekizumab
Experimental
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52 during the double-blind period.
Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label week 16 and 44.
Drug: Ixekizumab
Placebo
Placebo Comparator
Participants received placebo as 2 SC injections Q2W to week 52 during double-blind period.
Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Q2W Ixekizumab
Q4W Ixekizumab
Outcomes Module
Primary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
Week 16
Percentage of Participants Achieving an ASAS40 Response
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
Week 52
Secondary Outcomes
Measure
Description
Time Frame
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in axial spondyloarthritis (axSpA). ASDAS parameters used with (C-reactive protein [CRP] as acute phase reactant) are: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling, duration of morning stiffness 4) CRP in mg/L: ASDAScrp is calculated with the equation: 0.121 × total back pain + 0.110×patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least squares mean (LS Mean) was derived from mixed models repeated measure analysis (MMRM) with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Are ambulatory.
Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.
Have a history of back pain ≥3 months with age at onset <45 years.
Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.
Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).
In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.
If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.
Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.
Exclusion Criteria:
Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.
Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
Have a compromised immune system.
Have any other serious and/or uncontrolled diseases.
Have either a current diagnosis or a recent history of malignant disease.
Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
Are pregnant or breastfeeding.
Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.
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)
Reveille JD, Rudwaleit M, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Ng KJ, Gibble TH, Lisse J, Park SY, Kronbergs A, Navarro-Compan V. Does HLA-B27 Status Influence Ixekizumab Efficacy in Axial Spondyloarthritis? Results From the COAST-V, COAST-W, and COAST-X Trials. Rheumatol Ther. 2026 Feb;13(1):279-291. doi: 10.1007/s40744-025-00810-5. Epub 2025 Dec 19.
Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)
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 who completed study were eligible to enroll into a long-term study (Study I1F-MC-RHBY [RHBY]) for up to 2 additional years. Participants that do not enroll into study RHBY will complete the Post-Treatment Follow-Up Period.
Recruitment Details
This study has 3 periods: Period 1 - Screening; Period 2 - A Double-Blind Treatment Period (Weeks 0 Up to 52); (Inadequate Responders [IR] Week 16-52) followed by a Follow-Up Period (Up to 24 Weeks after last visit)
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
Placebo Double-Blind Period
Participants received placebo (PBO) as 2 subcutaneous (SC) injections every two weeks (Q2W) to week 52.
FG001
Ixekizumab 80 mg Q4W (IxeQ4W) Double-Blind Period
Periods
Title
Milestones
Reasons Not Completed
Double-Blind Period (Week 0 - Week 16)
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
Large Document Module
Document Has No Statistical Analysis Plan (SAP)
Not provided
Uploaded Document Information
Type
Includes Protocol
Includes SAP
Includes ICF
Document Label
Document Date
Document Uploaded Date
Document File Name
Prot
Yes
No
No
Study Protocol
Oct 5, 2018
Jan 16, 2020
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Not provided
Submission Tracking
No data available
No data is available for this block.
Condition Browse Module
MeSH Terms
Intervention Browse Module
MeSH Terms
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
Not provided
Primary Purpose
Treatment
Observational Model
Not provided
Time Perspective
Not provided
Masking Info
Masking
Double
Masking Description
Not provided
Who Masked
ParticipantInvestigator
LY2439821
Placebo
Drug
Administered SC
Placebo
Baseline, Week 16
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters used (with CRP as acute phase reactant) are: 1 )Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Number of Participants Without Clinically Meaningful Changes in Background Therapy
Number of participants without changes in background therapy while on originally randomized treatment.
Baseline through Week 52
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a 36-item patient-administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The Physical Component Summary score ranges from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The medical outcomes study 36-item short-form health survey (SF-36) SF-36 PCS are summarized using the t-scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Percentage of Participants Achieving ASDAS Low Disease Activity
ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 16
Percentage of Participants Achieving ASDAS Low Disease Activity
ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 52
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Both left and right SIJ are scored for bone marrow edema. Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LS Mean was derived from ANCOVA model with treatment, geographic region, screening MRI/CRP status and baseline value as fixed factors.
Baseline, Week 16
Change From Baseline in SPARCC Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. Participants were asked to rate the difficulty associated with 10 individual basic functional activities. Participant responded to each question using a NRS scale (range 0 to 10), with a higher score indicating worse functioning. The participant's final BASFI score is the mean of the 10 item scores with the minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Percentage of Participants Achieving ASDAS Inactive Disease
ASDAS is a composite index to assess disease activity in axSpA. ASDAS Inactive Disease is defined as a score of less than (<)1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Week 52
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High-sensitivity C-reactive protein (hs-CRP) was the measure of acute phase reactant and was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with axSpA: 1) Lateral spinal flexion 2) Tragus-to-wall distance 3) Lumbar flexion (modified Schrober) 4) Maximal intermalleolar distance, and 5) Cervical rotation. The BASMI includes these 5 measurements that were each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Chest Expansion
While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Occiput to Wall Distance
The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed included costochondral 1 (right/left [R/L]), costochondral 7 (R/L), spinal iliaca anterior superior (R/L), crista iliaca (R/L), spina iliaca posterior (R/L), processus spinosus L5, and achilles tendon proximal insertion (R/L). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body). The 46 joints are assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). Swollen joint count SJC was determined by examination of 44 joints (22 joints on each side of the participants body). The joints are classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which is multiplied by 44 to obtain SJC score. Score ranges from 0 (not swollen) to 44 (all joints swollen). LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status and baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Number of Participants With Anterior Uveitis
Number of participants with anterior uveitis. Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Baseline through Week 52
Change From Baseline in the Fatigue 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 rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in ASAS Health Index (ASAS HI)
ASAS-HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS Mean was derived MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS Mean was derived from using MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 52
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS Mean was derived from ANCOVA with treatment, geographic region, screening MRI/CRP status and baseline value.
Baseline, Week 52
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, the higher the score, the greater the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
Baseline, Week 52
Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies
A treatment-emergent positive anti-drug antibody (TE-ADA+) participant will be defined as a 4-fold increase over a positive baseline antibody titer (Tier 3); or for a negative baseline titer, a participant with an increase from the baseline to a level of ≥ 1:10.
Week 52
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
PK trough serum concentration samples were collected at steady state (Ctrough ss)
Week 52
El Cajon
California
92020
United States
Rheumatology Center of San Diego
Escondido
California
92025
United States
Care Access Research - Huntington Beach
Huntington Beach
California
92648
United States
Desert Medical Advances
Palm Desert
California
92260
United States
Inlande Rheumatology Clinical Trials
Upland
California
91786
United States
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs
Colorado
80920
United States
Clinical Research Center of CT/NY
Danbury
Connecticut
06810
United States
Sarasota Arthritis Center
Sarasota
Florida
34239
United States
West Broward Rheumatology Associates, Inc
Tamarac
Florida
33321
United States
Marietta Rheumatology
Marietta
Georgia
30060
United States
Institute of Arthritis Research
Idaho Falls
Idaho
83404
United States
The Arthritis & Diabetes Clinic Inc.
Monroe
Louisiana
71203
United States
Osteoporosis And Clinical Trial Center
Cumberland
Maryland
21502
United States
Osteoporosis And Clinical Trial Center
Hagerstown
Maryland
21740
United States
Glacier View Research Institute
Kalispell
Montana
59901
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Weill Cornell Physicians at Brooklyn Heights
Brooklyn
New York
11201
United States
Shanahan Rheumatology & Immunotherapy
Raleigh
North Carolina
27617
United States
Carolina Arthritis Associates
Wilmington
North Carolina
28401
United States
Oregon Health and Science University
Portland
Oregon
97239
United States
Altoona Center for Clinical Research
Duncansville
Pennsylvania
16635
United States
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia
South Carolina
29204
United States
Seattle Rheumatology Associates, P.L.L.C.
Seattle
Washington
98122
United States
Arthritis Northwest Rheumatology
Spokane
Washington
99204
United States
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Capital Federal
C1430EGF
Argentina
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Ciudad Autonoma de Buenos Aire
C1428DZF
Argentina
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Quilmes
B1878DVC
Argentina
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Rosario
S2000CFJ
Argentina
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Rosario
S2000DEJ
Argentina
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San Juan
J5402DIL
Argentina
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San Miguel de Tucumán
T4000AXL
Argentina
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San Miguel de Tucumán
T4000BRD
Argentina
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Vienna
1060
Austria
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Vienna
1090
Austria
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Goiás
74043-110
Brazil
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Juiz de Fora
36010-570
Brazil
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Rio de Janeiro
21941-913
Brazil
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Rio de Janeiro
22271-100
Brazil
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Québec
G1V 3M7
Canada
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St. John's
A1C 5B8
Canada
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Toronto
M5T 2S8
Canada
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Trois-Rivières
G8Z 1Y2
Canada
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Brno
611 41
Czechia
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Ostrava
703 00
Czechia
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Pardubice
530 02
Czechia
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Prague
128 50
Czechia
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Uherské Hradiště
686 01
Czechia
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Helsinki
00100
Finland
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Helsinki
00290
Finland
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Hyvinkää
05800
Finland
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Kuopio
70110
Finland
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Oulu
90029
Finland
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Halle
Saxony-Anhalt
06108
Germany
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Bad Doberan
18209
Germany
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Berlin
10117
Germany
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Hamburg
20095
Germany
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Hamburg
22081
Germany
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Herne
44649
Germany
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Bunkyō City
113-8431
Japan
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Chūōku
104-8560
Japan
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Kita-gun
761-0793
Japan
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Kuwana
511-0061
Japan
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Nankoku
783-8505
Japan
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Nishinomiya
663-8501
Japan
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Okayama
700-8607
Japan
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Osaka
534-0021
Japan
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Osaka
545-8586
Japan
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Ōsaka
5340021
Japan
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Sapporo
060-8648
Japan
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Sasebo
857-1195
Japan
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Suita-shi
565-0871
Japan
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Tenri
632-8552
Japan
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Yamagata
990-9585
Japan
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Chihuahua City
31000
Mexico
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Guadalajara
44620
Mexico
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Guadalajara
44650
Mexico
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Mexicali
21200
Mexico
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Mérida
97070
Mexico
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Monterrey
64460
Mexico
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San Luis Potosí City
78213
Mexico
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Amsterdam
1105 AZ
Netherlands
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Elblag
82-300
Poland
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Lodz
90-558
Poland
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Nadarzyn
05-830
Poland
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Poznan
61-397
Poland
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Świdnik
21-040
Poland
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Warsaw
03-291
Poland
Office: Perez-De Jesus, Amarilis
Caguas
PR
00725
Puerto Rico
Ponce School of Medicine CAIMED Center
Ponce
PR
00716
Puerto Rico
Mindful Medical Research
San Juan
PR
00918
Puerto Rico
Latin Clinical Trial Center
Santurce
00909
Puerto Rico
"For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician."
Bucharest
011025
Romania
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Bucharest
011172
Romania
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Constanța
900591
Romania
V.A. Nasonova Research Institute of Rheumatology
Moscow
115522
Russia
City Clinical Hospital #1
Moscow
119049
Russia
Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
Ryazan
390026
Russia
Clinical Rheumatology Hospital # 25
Saint Petersburg
190068
Russia
Saratov Regional Clinical Hospital
Saratov
410053
Russia
Clinical Hospital for Emergency Care
Yaroslavl
150003
Russia
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Daejeon
35015
South Korea
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Seoul
02447
South Korea
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Seoul
03080
South Korea
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Seoul
04763
South Korea
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Seoul
05030
South Korea
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Seoul
05278
South Korea
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Seoul
05505
South Korea
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Seoul
06273
South Korea
Derived
Navarro-Compan V, Reveille JD, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Panni T, Kronbergs A, Rudwaleit M. Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration. Adv Ther. 2025 Sep;42(9):4706-4716. doi: 10.1007/s12325-025-03305-5. Epub 2025 Jul 22.
Maksymowych WP, Baraliakos X, Lambert RG, Landewe R, Sandoval D, Carlier H, Lisse J, Li X, Hojnik M, Ostergaard M. Effects of ixekizumab treatment on structural changes in the sacroiliac joint: MRI assessments at 16 weeks in patients with non-radiographic axial spondyloarthritis. Lancet Rheumatol. 2022 Sep;4(9):e626-e634. doi: 10.1016/S2665-9913(22)00185-0. Epub 2022 Aug 9.
Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
Ortolan A, Ramiro S, Ramonda R, van der Heijde D. External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab. Rheumatology (Oxford). 2023 Jun 1;62(6):2257-2261. doi: 10.1093/rheumatology/keac618.
van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.
Deodhar A, Mease P, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Lauzon S, Leung A, Navarro-Compan V. Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks. BMC Rheumatol. 2021 Sep 25;5(1):50. doi: 10.1186/s41927-021-00218-y.
Deodhar A, Mease P, Rahman P, Navarro-Compan V, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Leon L, Shan M, Leung A, De Vlam K, Strand V. Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial. Rheumatol Ther. 2021 Mar;8(1):135-150. doi: 10.1007/s40744-020-00254-z. Epub 2020 Dec 7.
Walsh JA, Magrey MN, Baraliakos X, Inui K, Weng MY, Lubrano E, van der Heijde D, Boonen A, Gensler LS, Strand V, Braun J, Hunter T, Li X, Zhu B, Leon L, Calderon DMS, Kiltz U. Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial. Arthritis Care Res (Hoboken). 2022 Mar;74(3):451-460. doi: 10.1002/acr.24482. Epub 2022 Jan 26.
Deodhar A, van der Heijde D, Gensler LS, Kim TH, Maksymowych WP, Ostergaard M, Poddubnyy D, Marzo-Ortega H, Bessette L, Tomita T, Leung A, Hojnik M, Gallo G, Li X, Adams D, Carlier H, Sieper J; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020 Jan 4;395(10217):53-64. doi: 10.1016/S0140-6736(19)32971-X. Epub 2019 Dec 5.
Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
FG002
Ixekizumab 80 mg Q2W (IxeQ2W) Double-Blind Period
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC (Q2W) to week 52.
FG003
PBO IR/Ixe80Q2W-Open Label
Participants who received placebo in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
FG004
Ixekizumab 80 mg Q4W IR (Ixe80Q4WIR)/Ixe80Q2W-Open Label
Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
FG005
Ixekizumab 80 mg Q2W IR (Ixe80Q2WIR)/Ixe80Q2W-Open Label
Participants who received ixekizumab 80 mg Q2W in double blind period and were inadequate responders as determined by investigators continued on the same regimen of ixekizumab 80 mg Q2W open label.
FG006
Placebo Post Treatment Follow-Up Period
Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.
FG007
Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period
Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.
FG008
Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period
Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period
FG009
Other Biologic Treatment Group
Participants who discontinued study treatment and were on other biologic therapy prior to entering follow-up period.
FG000105 subjects
FG00196 subjects
FG002102 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Received at Least One Dose of Study Drug
FG000104 subjects
FG00196 subjects
FG002102 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00097 subjects
FG00195 subjects
FG00298 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
NOT COMPLETED
FG0008 subjects
FG0011 subjects
FG0024 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Lost to Follow-up
FG0000 subjects
FG0010 subjects
FG0021 subjects
FG0030 subjects
FG004
Withdrawal by Subject
FG0006 subjects
FG0011 subjects
FG0022 subjects
FG0030 subjects
FG004
Double-Blind Period (Week 16 - Week 52)
Type
Comment
Milestone Data
STARTED
FG00097 subjects
FG00195 subjects
FG00298 subjects
FG0030 subjects
FG0040 subjects
FG0050 subjects
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
COMPLETED
FG00034 subjects
FG00152 subjects
FG00252 subjects
FG0030 subjects
FG004
NOT COMPLETED
FG00063 subjects
FG00143 subjects
FG00246 subjects
FG0030 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
IR-Open Label Period (Week 16 - Week 52)
Type
Comment
Milestone Data
STARTED
FG0000 subjectsParticipants continued with original assigned treatment without switching to open label ixeQ2W.
FG0010 subjectsParticipants continued with original assigned treatment without switching to open label ixeQ2W.
FG0020 subjectsParticipants continued with original assigned treatment without switching to open label ixeQ2W.
FG00362 subjectsIR based on the investigator's opinion switched to ixekizumab open label 80 mg Q2W.
FG00440 subjectsIR based on the investigator's opinion switched to ixekizumab open label 80 mg Q2W.
FG00542 subjectsIR based on the investigator's opinion switched to ixekizumab open label 80 mg Q2W.
FG0060 subjects
FG0070 subjects
FG0080 subjects
FG0090 subjects
Initiated Other Biologic Rescue
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0032 subjects
FG004
COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG00355 subjects
FG004
NOT COMPLETED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0037 subjects
FG004
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG003
Follow-Up Period
Type
Comment
Milestone Data
STARTED
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjectsParticipants who completed the study were eligible to enroll in RHBY or enter follow up period.
FG0040 subjectsParticipants who completed the study were eligible to enroll in RHBY or enter follow up period.
FG0050 subjectsParticipants who completed the study were eligible to enroll in RHBY or enter follow up period.
FG0063 subjectsParticipants who completed the study were eligible to enroll in RHBY or enter follow up period.
FG0075 subjectsParticipants who completed the study were eligible to enroll in RHBY or enter follow up period.
FG00828 subjectsParticipants who completed the study were eligible to enroll in RHBY or enter follow up period.
FG0095 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
Adverse Event
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 as 2 SC injections Q2W to week 52.
BG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
BG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000105
BG00196
BG002102
BG003303
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Participants who had evaluable data for age were reported due to 1 participant that did not receive study drug.
Mean
Standard Deviation
years
Title
Denominators
Categories
ParticipantsBG000104
ParticipantsBG00196
ParticipantsBG002102
ParticipantsBG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000105
ParticipantsBG00196
ParticipantsBG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000105
ParticipantsBG00196
ParticipantsBG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
ParticipantsBG000105
ParticipantsBG00196
ParticipantsBG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Argentina
ParticipantsBG000105
ParticipantsBG00196
ParticipantsBG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG00019.0
OG00135.4
OG00240.2
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.009
Odds Ratio (OR)
2.36
2-Sided
95
1.23
4.51
Superiority
OG000
OG002
Regression, Logistic
0.002
Primary
Percentage of Participants Achieving an ASAS40 Response
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the nonresponder imputation (NRI) method.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Secondary
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in axial spondyloarthritis (axSpA). ASDAS parameters used with (C-reactive protein [CRP] as acute phase reactant) are: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling, duration of morning stiffness 4) CRP in mg/L: ASDAScrp is calculated with the equation: 0.121 × total back pain + 0.110×patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least squares mean (LS Mean) was derived from mixed models repeated measure analysis (MMRM) with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Secondary
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters used (with CRP as acute phase reactant) are: 1 )Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Number of Participants Without Clinically Meaningful Changes in Background Therapy
Number of participants without changes in background therapy while on originally randomized treatment.
All randomized participants. Additional analysis not performed due to small number of participants with changes in background therapy and complete overlap with switch to open-label ixekizumab.
Posted
Count of Participants
Participants
No
Baseline through Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a 36-item patient-administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The Physical Component Summary score ranges from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52..
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The medical outcomes study 36-item short-form health survey (SF-36) SF-36 PCS are summarized using the t-scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Secondary
Percentage of Participants Achieving ASDAS Low Disease Activity
ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
All randomized participants with baseline ASDAS <2.1. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.
Posted
Number
percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Percentage of Participants Achieving ASDAS Low Disease Activity
ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
All randomized participants with baseline ASDAS <2.1. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Secondary
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Both left and right SIJ are scored for bone marrow edema. Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LS Mean was derived from ANCOVA model with treatment, geographic region, screening MRI/CRP status and baseline value as fixed factors.
All randomized participants with baseline and Week 16 SPARCC score. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Secondary
Change From Baseline in SPARCC Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
All randomized participants with a baseline SPARCC score >0. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. Participants were asked to rate the difficulty associated with 10 individual basic functional activities. Participant responded to each question using a NRS scale (range 0 to 10), with a higher score indicating worse functioning. The participant's final BASFI score is the mean of the 10 item scores with the minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Percentage of Participants Achieving ASDAS Inactive Disease
ASDAS is a composite index to assess disease activity in axSpA. ASDAS Inactive Disease is defined as a score of less than (<)1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.
Posted
Number
percentage of participants
Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High-sensitivity C-reactive protein (hs-CRP) was the measure of acute phase reactant and was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
milligram/liter (mg/L)
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with axSpA: 1) Lateral spinal flexion 2) Tragus-to-wall distance 3) Lumbar flexion (modified Schrober) 4) Maximal intermalleolar distance, and 5) Cervical rotation. The BASMI includes these 5 measurements that were each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Change From Baseline in Chest Expansion
While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
centimeter (cm)
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Secondary
Change From Baseline in Occiput to Wall Distance
The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
cm
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Secondary
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed included costochondral 1 (right/left [R/L]), costochondral 7 (R/L), spinal iliaca anterior superior (R/L), crista iliaca (R/L), spina iliaca posterior (R/L), processus spinosus L5, and achilles tendon proximal insertion (R/L). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline Mases score > 0. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body). The 46 joints are assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). Swollen joint count SJC was determined by examination of 44 joints (22 joints on each side of the participants body). The joints are classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which is multiplied by 44 to obtain SJC score. Score ranges from 0 (not swollen) to 44 (all joints swollen). LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status and baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline TJC>0 for the TJC analysis. All randomized participants with baseline SJC>0 for the SJC analysis. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
joint counts
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Secondary
Number of Participants With Anterior Uveitis
Number of participants with anterior uveitis. Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
All randomized participants regardless of history of anterior uveitis. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Count of Participants
Participants
No
Baseline through Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Secondary
Change From Baseline in the Fatigue 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 rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Secondary
Change From Baseline in ASAS Health Index (ASAS HI)
ASAS-HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS Mean was derived MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Secondary
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS Mean was derived from using MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Least Squares Mean
Standard Error
units on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
Secondary
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS Mean was derived from ANCOVA with treatment, geographic region, screening MRI/CRP status and baseline value.
All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data were imputed using the modified baseline observation carried forward (mBOCF).
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Secondary
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, the higher the score, the greater the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
All randomized participants who had NSAID (including COX-2 Inhibitor) intake at Baseline. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo
Participants received placebo as 2 SC injections Q2W to week 52.
OG001
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 and placebo followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Secondary
Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies
A treatment-emergent positive anti-drug antibody (TE-ADA+) participant will be defined as a 4-fold increase over a positive baseline antibody titer (Tier 3); or for a negative baseline titer, a participant with an increase from the baseline to a level of ≥ 1:10.
All randomized participant who received at least one dose of ixekizumab during the study and had an evaluable baseline sample and at least 1 evaluable post baseline sample.
Posted
Count of Participants
Participants
No
Week 52
ID
Title
Description
OG000
Ixe80Q2W-Q2W
Participants received a starting dose of 80 ixekizumab as an SC injection at week 0 followed by 80 mg of ixe every two weeks (Q2W) week 2 to week 52.
OG001
Ixe80Q4W-Q4W
Participants received a starting dose of 80 ixekizumab as an SC injection followed by 80 mg of ixekizumab Q4W week 4 to week 52.
OG002
PBO-Ixe80Q2W
Participants who received placebo in double blind period and were inadequate responders switched to ixekizumab 80 mg Q2W open-label.
OG003
Secondary
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
PK trough serum concentration samples were collected at steady state (Ctrough ss)
All randomized participants who had evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram/milliliter (μg/mL)
Week 52
ID
Title
Description
OG000
IxeQ2W (80S)/IxeQ2W
Ixekizumab was administered subcutaneously every 2 weeks with an 80 mg starting dose at week 0.
OG001
IxeQ2W (80S)/IxeQ2W Open Label
Ixekizumab was administered every 2 weeks with an 80 mg starting dose at Week 0, then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
OG002
IxeQ2W (160S)/IxeQ2W
Ixekizumab was administered subcutaneously every 2 weeks with an 160 mg starting dose at week 0.
OG003
IxeQ2W (160s)/IxeQ2W Open Label
Ixekizumab was administered subcutaneously every 2 weeks with an 160 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
Time Frame
Up to 76 Weeks
Description
All randomized participants who received at least one dose of study drug during the study. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
All-Cause Mortality Comment
Not provided
Arm/Groups
ID
Title
Description
Deaths (Affected)
Deaths (At Risk)
Serious Events (Affected)
Serious Events (At Risk)
Other Events (Affected)
Other Events (At Risk)
EG000
Placebo Double-Blind Period
Participants received placebo as 2 SC injections Q2W to week 52.
0
104
1
104
31
104
EG001
Ixekizumab 80 mg Q4W Double-Blind Period
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
0
96
2
96
43
96
EG002
Ixekizumab 80 mg Q2W Double-Blind Period
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
0
102
1
102
47
102
EG003
PBO IR/IxeQ2W Open Label
Participants who received placebo in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
0
42
1
42
13
42
EG004
Ixe80Q4WIR/Ixe80Q2W Open Label
Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label.
0
40
0
40
15
40
EG005
Ixe80Q2WIR/Ixe80Q2W Open Label
Participants who received ixekizumab 80 mg Q2W in double blind period and were inadequate responders as determined by investigators continued on the same regimen of ixekizumab 80 mg Q2W open label.
0
62
2
62
26
62
EG006
Other Biologic Open Label
Participants who discontinued study treatment and were on other biologic therapy prior to entering Follow-up period
0
5
0
5
3
5
EG007
Placebo Post Treatment Follow-Up Period
Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period.
0
3
0
3
1
3
EG008
Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period
Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period.
0
5
0
5
1
5
EG009
Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period
Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period.
0
28
1
28
1
28
EG010
Other Biologic Post Treatment Follow-Up Period
Participants who discontinued study treatment and were on other biologic therapy prior to entering follow-up period.
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG00013.3
OG00130.2
OG00231.4
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
0.004
Odds Ratio (OR)
2.82
2-Sided
95
1.38
5.77
Superiority
OG000
OG002
Regression, Logistic
0.004
Odds Ratio (OR)
2.85
2-Sided
95
1.40
5.77
Superiority
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-0.58± 0.095
OG001-1.12± 0.097
OG002-1.26± 0.095
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
Mixed Models Analysis
<0.001
LS Mean Difference
-0.54
Standard Error of the Mean
0.136
2-Sided
95
-0.81
-0.28
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference
-0.68
Standard Error of the Mean
0.134
2-Sided
95
-0.94
-0.41
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-0.78± 0.136
OG001-1.39± 0.116
OG002-1.47± 0.116
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
Mixed Models Analysis
<0.001
LS Mean Difference
-0.61
Standard Error of the Mean
0.179
2-Sided
95
-0.96
-0.26
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference
-0.69
Standard Error of the Mean
0.178
2-Sided
95
-1.05
-0.34
Superiority
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG00098
OG00190
OG002100
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG0005.2103± 0.7999
OG0018.0612± 0.8129
OG0027.9600± 0.8023
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
Mixed Models Analysis
0.013
LS Mean Difference
2.8509
Standard Error of the Mean
1.1390
2-Sided
95
0.6092
5.0926
Superiority
OG000
OG002
Mixed Models Analysis
0.015
LS Mean Difference
2.7497
Standard Error of the Mean
1.1278
2-Sided
95
0.5299
4.9694
Superiority
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG0004.7210± 1.2459
OG0018.9211± 1.0783
OG0029.3291± 1.0810
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
Mixed Models Analysis
0.012
LS Mean Difference
4.2001
Standard Error of the Mean
1.6467
2-Sided
95
0.9525
7.4477
Superiority
OG000
OG002
Mixed Models Analysis
0.006
LS Mean Difference
4.6081
Standard Error of the Mean
1.6455
2-Sided
95
1.3629
7.8533
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00194
OG002102
Title
Denominators
Categories
Title
Measurements
OG00012.4
OG00127.7
OG00232.4
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
0.008
Odds Ratio (OR)
2.73
2-Sided
95
1.30
5.76
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.43
2-Sided
95
1.66
7.08
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00194
OG002102
Title
Denominators
Categories
Title
Measurements
OG0008.6
OG00129.8
OG00227.5
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
<0.001
Odds Ratio (OR)
4.58
2-Sided
95
2.02
10.41
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.99
2-Sided
95
1.76
9.05
Superiority
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-1.51± 0.216
OG001-2.18± 0.220
OG002-2.52± 0.217
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
Mixed Models Analysis
0.031
LS Means Square Difference
-0.67
Standard Error of the Mean
0.308
2-Sided
95
-1.28
-0.06
Superiority
OG000
OG002
Mixed Models Analysis
0.001
LS Mean Difference
-1.01
Standard Error of the Mean
0.305
2-Sided
95
-1.61
-0.41
Superiority
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-1.76± 0.305
OG001-2.89± 0.266
OG002-3.04± 0.266
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
Mixed Models Analysis
0.006
LS Mean Difference
-1.13
Standard Error of the Mean
0.404
2-Sided
95
-1.92
-0.33
Superiority
OG000
OG002
Mixed Models Analysis
0.002
LS Mean Difference
-1.29
Standard Error of the Mean
0.404
2-Sided
95
-2.08
-0.49
Superiority
Units
Counts
Participants
OG00090
OG00185
OG00292
Title
Denominators
Categories
Title
Measurements
OG000-0.31± 0.539
OG001-3.38± 0.549
OG002-4.52± 0.530
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
ANCOVA
<0.001
LS Mean Difference
-3.07
Standard Error of the Mean
0.764
2-Sided
95
-4.58
-1.57
Superiority
OG000
OG002
ANCOVA
<0.001
LS Mean Difference
-4.20
Standard Error of the Mean
0.751
2-Sided
95
-5.68
-2.72
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG00086
OG00165
OG00274
Title
Denominators
Categories
Title
Measurements
OG000-2.87± 0.447
OG001-2.99± 0.427
OG002-3.14± 0.407
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
Mixed Models Analysis
0.849
LS Mean Difference
-0.12
Standard Error of the Mean
0.621
2-Sided
95
-1.35
1.11
Superiority
OG000
OG002
Mixed Models Analysis
0.648
LS Mean Difference
-0.28
Standard Error of the Mean
0.608
2-Sided
95
-1.48
0.93
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-1.57± 0.333
OG001-2.63± 0.292
OG002-2.75± 0.291
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
Mixed Models Analysis
0.018
LS Mean Difference
-1.06
Standard Error of the Mean
0.443
2-Sided
95
-1.93
-0.18
Superiority
OG000
OG002
Mixed Models Analysis
0.008
LS Mean Difference
-1.18
Standard Error of the Mean
0.442
2-Sided
95
-2.05
-0.31
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG0002.9
OG00113.5
OG00210.8
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
0.0011
Odds Ratio (OR)
5.33
2-Sided
96
1.47
19.40
Superiority
OG000
OG002
Regression, Logistic
0.031
Odds Ratio (OR)
4.22
2-Sided
95
1.14
15.66
Superiority
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-4.804± 2.0370
OG001-8.611± 2.0028
OG002-7.547± 1.9654
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
Mixed Models Analysis
0.183
LS Mean Difference
-3.807
Standard Error of the Mean
2.8507
2-Sided
95
-9.418
1.804
Superiority
OG000
OG002
Mixed Models Analysis
0.331
LS Mean Difference
-2.743
Standard Error of the Mean
2.8202
2-Sided
95
-8.294
2.807
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-0.17± 0.112
OG001-0.56± 0.097
OG002-0.48± 0.097
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
Mixed Models Analysis
0.008
LS Mean Difference
-0.40
Standard Error of the Mean
0.148
2-Sided
95
-0.69
-0.10
Superiority
OG000
OG002
Mixed Models Analysis
0.038
LS Mean Difference
-0.31
Standard Error of the Mean
0.148
2-Sided
95
-0.60
-0.02
Superiority
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG0000.57± 0.253
OG0010.62± 0.206
OG0020.91± 0.209
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
Mixed Models Analysis
0.871
LS Mean Difference
0.05
Standard Error of the Mean
0.325
2-Sided
95
-0.59
0.70
Superiority
OG000
OG002
Mixed Models Analysis
0.295
LS Mean Difference
0.34
Standard Error of the Mean
0.327
2-Sided
95
-0.30
0.99
Superiority
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG0000.04± 0.312
OG001-0.42± 0.257
OG002-0.73± 0.259
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
Mixed Models Analysis
0.257
LS Mean Difference
-0.46
Standard Error of the Mean
0.406
2-Sided
95
-1.26
0.34
Superiority
OG000
OG002
Mixed Models Analysis
0.057
LS Mean Difference
-0.77
Standard Error of the Mean
0.402
2-Sided
95
-1.56
0.02
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-2.34± 0.361
OG001-3.21± 0.342
OG002-3.19± 0.336
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
Mixed Models Analysis
0.082
LS Mean Difference
-0.87
Standard Error of the Mean
0.496
2-Sided
95
-1.85
0.11
Superiority
OG000
OG002
Mixed Models Analysis
0.088
LS Mean Difference
-0.85
Standard Error of the Mean
0.493
2-Sided
95
-1.82
0.13
Superiority
Ixekizumab 80 mg Q4W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
TJC
ParticipantsOG00083
ParticipantsOG00170
ParticipantsOG00286
Title
Measurements
OG000-0.59± 1.039
OG001-2.38± 0.993
OG002-4.12± 0.916
SJC
ParticipantsOG00050
ParticipantsOG00151
ParticipantsOG00257
Title
Measurements
OG000
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
TJC
Mixed Models Analysis
0.219
LS Mean Difference
-1.79
Standard Error of the Mean
1.442
2-Sided
95
-4.66
1.09
Superiority
OG000
OG002
TJC
Mixed Models Analysis
0.013
LS Mean Difference
-3.53
Standard Error of the Mean
1.388
2-Sided
95
-6.30
-0.76
Superiority
OG000
OG001
SJC
Mixed Models Analysis
0.009
LS Mean Difference
-0.97
Standard Error of the Mean
0.355
2-Sided
95
-1.68
-0.26
Superiority
OG000
OG002
SJC
Mixed Models Analysis
0.034
LS Mean Difference
-0.76
Standard Error of the Mean
0.348
2-Sided
95
-1.46
-0.06
Superiority
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG0002
OG0011
OG0022
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.38
OG001-2.6± 0.32
OG002-2.7± 0.32
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
Mixed Models Analysis
0.325
LS Mean Difference
-0.5
Standard Error of the Mean
0.50
2-Sided
95
-1.5
0.5
Superiority
OG000
OG002
Mixed Models Analysis
0.206
LS Mean Difference
-0.6
Standard Error of the Mean
0.50
2-Sided
95
-1.6
0.4
Superiority
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-2.57± 0.455
OG001-3.16± 0.395
OG002-3.54± 0.396
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
Mixed Models Analysis
0.330
LS Mean Difference
-0.59
Standard Error of the Mean
0.601
2-Sided
95
-1.77
0.60
Superiority
OG000
OG002
Mixed Models Analysis
0.110
LS Mean Difference
-0.97
Standard Error of the Mean
0.602
2-Sided
95
-2.15
0.22
Superiority
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Title
Measurements
OG000-2.9± 0.63
OG001-3.6± 0.52
OG002-3.6± 0.53
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
Mixed Models Analysis
0.348
LS Mean Difference
-0.8
Standard Error of the Mean
0.81
2-Sided
95
-2.4
0.8
Superiority
OG000
OG002
Mixed Models Analysis
0.386
LS Mean Difference
-0.7
Standard Error of the Mean
0.82
2-Sided
95
-2.3
0.9
Superiority
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52.
OG002
Ixekizumab 80 mg Q2W
Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
Units
Counts
Participants
OG000105
OG00196
OG002102
Title
Denominators
Categories
Overall Impairment Score
Title
Measurements
OG000-13.20± 3.386
OG001-26.96± 3.439
OG002-19.49± 3.221
Percentage of absenteeism
Title
Measurements
OG000-3.11± 2.215
OG001-9.01± 2.257
OG002-7.26± 2.151
Percentage of presenteeism
Title
Measurements
OG000-12.40± 3.200
OG001-26.01± 3.245
OG002-18.61± 3.047
Percentage of impairment in activities
Title
Measurements
OG000-14.42± 2.584
OG001-25.05± 2.617
OG002-24.41± 2.567
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
Overall Impairment Score
ANCOVA
0.005
LS Mean Difference
-13.76
Standard Error of the Mean
4.835
2-Sided
95
-23.32
-4.20
Superiority
OG000
OG002
Overall Impairment Score
ANCOVA
0.183
LS Mean Difference
-6.29
Standard Error of the Mean
4.697
2-Sided
95
-15.58
3.00
Superiority
OG000
OG001
Percentage of absenteeism
ANCOVA
0.060
LS Mean Difference
-5.90
Standard Error of the Mean
3.114
2-Sided
95
-12.05
0.26
Superiority
OG000
OG002
Percentage of absenteeism
ANCOVA
0.182
LS Mean Difference
-4.15
Standard Error of the Mean
3.098
2-Sided
95
-10.27
1.97
Superiority
OG000
OG001
Percentage of presentism
ANCOVA
0.003
LS Mean Difference
-13.61
Standard Error of the Mean
4.558
2-Sided
95
-22.62
-4.60
Superiority
OG000
OG002
Percentage of presentism
ANCOVA
0.164
LS Mean Difference
-6.21
Standard Error of the Mean
4.446
2-Sided
95
-15.00
2.58
Superiority
OG000
OG001
Percentage of Impairment in Activities Performed Outside of Work
LS Mean Difference
0.004
LS Mean Difference
-10.63
Standard Error of the Mean
3.669
2-Sided
95
-17.85
-3.41
Superiority
OG000
OG002
Percentage of Impairment in Activities Performed Outside of Work
ANCOVA
0.006
LS Mean Difference
-9.99
Standard Error of the Mean
3.621
2-Sided
95
-17.12
-2.86
Superiority
Units
Counts
Participants
OG00096
OG00181
OG00295
Title
Denominators
Categories
Title
Measurements
OG000-8.89± 29.986
OG001-7.91± 34.257
OG002-5.33± 20.935
Ixe80Q4W-Q2W
Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders switched to ixekizumab 80 mg Q2W open label.
Units
Counts
Participants
OG000102
OG00156
OG00262
OG00340
Title
Denominators
Categories
Title
Measurements
OG00014
OG0015
OG0028
OG0032
OG004
IxeQ4W (80S) IxeQ4W
Ixekizumab was administered subcutaneously every 4 weeks with an 80 mg starting dose at week 0.
OG005
IxeQ4W (80S)/IxeQ2W Open Label
Ixekizumab was administered subcutaneously every 4 weeks with an 80 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
OG006
IxeQ4W(160S)/IxeQ4W
Ixekizumab was administered subcutaneously every 4 weeks with an 160 mg starting dose at week 0.
OG007
IxeQ4W (160S) IxeQ2W Open Label
Ixekizumab was administered subcutaneously every 4 weeks with an 160 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
OG008
PBO/IxeQ2W Open Label
Placebo was administered at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.