A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experi... | NCT02696798 | Trialant
NCT02696798
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Jun 17, 2020Actual
Enrollment
316Actual
Phase
Phase 3
Conditions
Spondyloarthritis
Interventions
Ixekizumab
Placebo
Countries
United States
Argentina
Brazil
Canada
Finland
France
Germany
Israel
Italy
Japan
Mexico
Netherlands
Poland
Puerto Rico
South Korea
Spain
United Kingdom
Protocol Section
Identification Module
NCT ID
NCT02696798
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16179
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBW
Other Identifier
Eli Lilly and Company
2015-003937-84
EudraCT Number
Brief Title
A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis
Official Title
A Multicenter, Randomized, Double-Blind, Placebo- Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in TNFi-Experienced Patients With Radiographic Axial Spondyloarthritis
Acronym
COAST-W
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Jun 2020
Overall Recruitment Status or Expanded Access Status
Completed
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Not provided
Expanded Access Info
No
Start Date
Apr 12, 2016Actual
Primary Completion Date
May 18, 2018Actual
Completion Date
May 3, 2019Actual
First Submitted Date
Feb 26, 2016
First Submission Date that Met QC Criteria
Feb 26, 2016
First Posted Date
Mar 2, 2016Estimated
Results Waived
Not provided
Results First Submitted Date
Sep 24, 2019
Results First Submitted that Met QC Criteria
Oct 25, 2019
Results First Posted Date
Oct 30, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 5, 2018
Certification/Extension First Submitted that Passed QC Review
Jun 5, 2018
Certification/Extension First Posted Date
Jun 8, 2018Actual
Last Update Submitted Date
Jun 10, 2020
Last Update Posted Date
Jun 17, 2020Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).
Detailed Description
Not provided
Conditions Module
Conditions
Spondyloarthritis
Keywords
Ankylosing Spondylitis
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
316Actual
Arms/Interventions Module
Arm Groups
Label
Type
Description
Intervention Names
Q2W Ixekizumab
Experimental
Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Drug: Ixekizumab
Q4W Ixekizumab
Experimental
Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Drug: Ixekizumab
Placebo
Placebo Comparator
Double Blind Period: Placebo given SC Q2W to week 14.
Extended Treatment Period: Starting dose of 160 mg ixekizumab given SC at week 16 followed by 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.
Drug: Ixekizumab
Drug: Placebo
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Placebo
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 improvement from baseline of greater than or equal to (>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain.
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Week 16
Secondary Outcomes
Measure
Description
Time Frame
Percentage of Participants Achieving an ASAS20 Response
ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
Other Outcomes
Not provided
Eligibility Module
Eligibility Criteria
Inclusion Criteria:
Are ambulatory.
Have an established diagnosis of radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
Participants have a history of back pain ≥3 months with age at onset <45 years.
Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.
Exclusion Criteria:
Have total ankylosis of the spine.
Have never taken a TNF inhibitor medication or have taken more than 2.
Have recently 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.
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.
Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Types
Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame
Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
Participants who completed study were eligible to enroll into a long-term study (I1F-MC-RHBY [NCT03129100]) for up to 2 additional years. Participants who terminate study RHBW early or who do not enroll into Study RHBY will complete the Post-Treatment Follow-Up (PTFU) Period in study RHBW.
Recruitment Details
Blinded Treatment Dosing Period (Week 0 to Week 16), Extended Treatment Period (Week 16 to Week 52) followed by post-treatment follow-up period occurring from last treatment visit (week 52), or Early Termination Visit (ETV) up to a minimum of 12 weeks following that visit.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PBO/IXE
Blinded Treatment Dosing Period: Participants received placebo (PBO) every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab (IXE) 80 mg every four weeks (Q4W) or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Periods
Title
Milestones
Reasons Not Completed
Blinded Treatment Dosing Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
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
Jun 2, 2017
Aug 26, 2019
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
Week 16
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in AS. 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 scores indicated higher disease activity. Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with treatment, geographic region, baseline CRP status, number of prior tumor necrosis factor inhibitor (TNFi), baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-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. BASDAI50 represents an improvement of ≥50% of the BASDAI score from 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 radiographic axial spondyloarthritis (rad-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. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, 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 Functional Index (BASFI)
The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Participants respond to each question using an NRS scale (range 0 to 10). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Percentage of Participants Achieving ASDAS Inactive Disease
ASDAS is a composite index to assess disease activity in AS. ASDAS Inactive Disease is defined as a score of <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 16
Percentage of Participants Achieving ASDAS <2.1
ASDAS is a composite index to assess disease activity in AS. ASDAS <2.1 defines moderate disease activity.
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
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a 36-item participant 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 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in ASAS Health Index (ASAS HI)
The ASAS Health Index (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 1 question that the patient needs to respond to with either "I agree" (score 1) or "I do not agree (score 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 determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)
The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of the 23 disco-vertebral units (DVU) of the spine (from C2 to S1), capturing bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease.LS mean was determined by analysis of covariance (ANCOVA) with treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value as fixed factors.
Baseline, Week 16
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Scoring was performed by central readers. LS mean was determined by ANCOVA with factors for treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value.
Baseline, Week 16
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA).
Lateral Spinal Flexion
Tragus-to-wall distance
Lumbar Flexion (modified Schober)
Maximal intermalleolar distance and
Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Chest Expansion
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While patients have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
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 determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The 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 include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Spondyloarthritis Research Consortium of Canada (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 determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.
Baseline, Week 16
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.
Baseline, Week 16
Percentage 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.
Week 16
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 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
The 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 determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
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 determined by ANCOVA with treatment, geographic region, baseline CRP status, number of prior TNFi and baseline value as fixed factors.
Baseline, Week 16
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, higher the score greated 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
Percentage of Participants With Anti-Ixekizumab Antibodies
A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
Week 16
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.
Week 16
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
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs
Colorado
80920
United States
Denver Arthritis Center
Denver
Colorado
80230
United States
Clinical Research Center of CT/NY
Danbury
Connecticut
06810
United States
Arthritis Rheumatic Disease Specialties
Aventura
Florida
33180
United States
Sarasota Arthritis Center
Sarasota
Florida
34239
United States
Marietta Rheumatology
Marietta
Georgia
30060
United States
St Luke's Clinic - Intermountain Orthopaedics
Boise
Idaho
83702
United States
Institute of Arthritis Research
Idaho Falls
Idaho
83404
United States
Center for Arthritis & Osteoporosis
Elizabethtown
Kentucky
42701
United States
Klein and Associates MD, PA
Cumberland
Maryland
21502
United States
Osteoporosis And Clinical Trial Center
Hagerstown
Maryland
21740
United States
Arthritis Consultants
St Louis
Missouri
63141
United States
The Center for Rheumatology
Albany
New York
12203
United States
Shanahan Rheumatology & Immunotherapy
Raleigh
North Carolina
27617
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
Low Country Research Center
North Charleston
South Carolina
29406
United States
Univ of Texas Health Science Center - Houston
Houston
Texas
77030
United States
Southwest Rheumatology, P.A.
Mesquite
Texas
75150
United States
Center for Arthritis and Rheumatic Diseases, PC
Chesapeake
Virginia
23320
United States
Arthritis Northwest Rheumatology
Spokane
Washington
99204
United States
Rheumatology and Immunotherapy Center
Franklin
Wisconsin
53132
United States
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician.
Rosario
S2000CFJ
Argentina
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Rosario
S2000DEJ
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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Curitiba
80440-080
Brazil
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Goiás
74043-110
Brazil
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Juiz de Fora
36010-570
Brazil
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Porto Alegre
90480-000
Brazil
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São Paulo
01244-030
Brazil
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St. John's
A1C 5B8
Canada
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Trois-Rivières
G8Z 1Y2
Canada
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Victoria
V8V 3M9
Canada
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Helsinki
00029
Finland
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Hyvinkää
05800
Finland
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Oulu
90029
Finland
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Clermont
63003
France
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Le Kremlin-Bicêtre
94270
France
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Montpellier
34295
France
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Orléans
45100
France
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Paris
75679
France
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Tours
37044
France
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Berlin
10117
Germany
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Ashkelon
7830604
Israel
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Haifa
3525408
Israel
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Petah Tikva
4941492
Israel
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Tel Aviv
6423906
Israel
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Milan
20157
Italy
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Reggio Emilia
42123
Italy
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Roma
00168
Italy
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Siena
53100
Italy
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Hyōgo
663-8501
Japan
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Yamagata
990-9585
Japan
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Chihuahua City
31000
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
64020
Mexico
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San Luis Potosí City
78213
Mexico
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Amsterdam
1105 AZ
Netherlands
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Sneek
8601 ZK
Netherlands
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Bydgoszcz
85-168
Poland
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Elblag
82-300
Poland
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Lodz
90-558
Poland
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Poznan
61-397
Poland
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Świdnik
21-040
Poland
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Warsaw
01-518
Poland
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Warsaw
02-691
Poland
Office: Perez-De Jesus, Amarilis
Caguas
PR
00725
Puerto Rico
GCM Medical Group PSC
San Juan
PR
00909
Puerto Rico
Mindful Medical Research
San Juan
PR
00918
Puerto Rico
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Santurce
00909
Puerto Rico
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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
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Seoul
06591
South Korea
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Seoul
07061
South Korea
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Córdoba
14004
Spain
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Elche
03202
Spain
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Madrid
28007
Spain
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Sabadell
08208
Spain
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Seville
41010
Spain
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Basingstoke
RG24 9NA
United Kingdom
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Norwich
NR4 7UY
United Kingdom
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Solihull
B91 3JL
United Kingdom
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Stoke-on-Trent
ST6 7AG
United Kingdom
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Wolverhampton
WV10 0QP
United Kingdom
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Wythenshawe
M23 9LT
United Kingdom
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.
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.
Maksymowych WP, Bolce R, Gallo G, Seem E, Geneus VJ, Sandoval DM, Ostergaard M, Tada K, Baraliakos X, Deodhar A, Gensler LS. Ixekizumab in radiographic axial spondyloarthritis with and without elevated C-reactive protein or positive magnetic resonance imaging. Rheumatology (Oxford). 2022 Nov 2;61(11):4324-4334. doi: 10.1093/rheumatology/keac104.
van der Heijde D, Ostergaard M, Reveille JD, Baraliakos X, Kronbergs A, Sandoval DM, Li X, Carlier H, Adams DH, Maksymowych WP. Spinal Radiographic Progression and Predictors of Progression in Patients With Radiographic Axial Spondyloarthritis Receiving Ixekizumab Over 2 Years. J Rheumatol. 2022 Mar;49(3):265-273. doi: 10.3899/jrheum.210471. Epub 2021 Dec 1.
Dougados M, Wei JC, Landewe R, Sieper J, Baraliakos X, Van den Bosch F, Maksymowych WP, Ermann J, Walsh JA, Tomita T, Deodhar A, van der Heijde D, Li X, Zhao F, Bertram CC, Gallo G, Carlier H, Gensler LS; COAST-V and COAST-W Study Groups. Efficacy and safety of ixekizumab through 52 weeks in two phase 3, randomised, controlled clinical trials in patients with active radiographic axial spondyloarthritis (COAST-V and COAST-W). Ann Rheum Dis. 2020 Feb;79(2):176-185. doi: 10.1136/annrheumdis-2019-216118. Epub 2019 Nov 4.
Deodhar A, Poddubnyy D, Pacheco-Tena C, Salvarani C, Lespessailles E, Rahman P, Jarvinen P, Sanchez-Burson J, Gaffney K, Lee EB, Krishnan E, Santisteban S, Li X, Zhao F, Carlier H, Reveille JD; COAST-W Study Group. Efficacy and Safety of Ixekizumab in the Treatment of Radiographic Axial Spondyloarthritis: Sixteen-Week Results From a Phase III Randomized, Double-Blind, Placebo-Controlled Trial in Patients With Prior Inadequate Response to or Intolerance of Tumor Necrosis Factor Inhibitors. Arthritis Rheumatol. 2019 Apr;71(4):599-611. doi: 10.1002/art.40753. Epub 2019 Mar 8.
FG001
IXE80Q4W/IXE80Q4W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
FG002
IXE80Q2W/IXE80Q2W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
FG000104 subjects
FG001114 subjects
FG00298 subjects
COMPLETED
FG00093 subjects
FG00199 subjects
FG00290 subjects
NOT COMPLETED
FG00011 subjects
FG00115 subjects
FG0028 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0019 subjects
FG0022 subjects
Death
FG0000 subjects
FG0010 subjects
FG0021 subjects
Lack of Efficacy
FG0002 subjects
FG0011 subjects
FG0021 subjects
Lost to Follow-up
FG0000 subjects
FG0011 subjects
FG0020 subjects
Physician Decision
FG0000 subjects
FG0011 subjects
FG0020 subjects
Withdrawal by Subject
FG0007 subjects
FG0013 subjects
FG0024 subjects
Extended Treatment Period
Type
Comment
Milestone Data
STARTED
FG00093 subjects
FG00198 subjects1 participant completed blinded treatment period and entered post-treatment followup period directly
FG00290 subjects
COMPLETED
FG00081 subjects
FG00189 subjects
FG00280 subjects
NOT COMPLETED
FG00012 subjects
FG0019 subjects
FG00210 subjects
Type
Comment
Reasons
Adverse Event
FG0001 subjects
FG0014 subjects
FG0025 subjects
Lack of Efficacy
FG000
Post-treatment Follow-up Period
Type
Comment
Milestone Data
STARTED
FG0005 subjectsParticipants who terminate RHBW early or who didn't enroll into RHBY entered Follow-Up Period.
FG00134 subjectsParticipants who terminate RHBW early or who didn't enroll into RHBY entered Follow-Up Period.
FG00222 subjectsParticipants who terminate RHBW early or who didn't enroll into RHBY entered Follow-Up Period.
COMPLETED
FG0000 subjects
FG0018 subjects
FG0023 subjects
NOT COMPLETED
FG0005 subjects
FG00126 subjects
FG00219 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG00112 subjects
FG0026 subjects
Lost to Follow-up
FG000
All randomized participants
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PBO/IXE
Blinded Treatment Dosing Period: Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab 80 mg Q4W or 80 mg Q2W at a 1:1 ratio with starting dose of 160 mg.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Participants did not receive any intervention during Follow-up period
BG001
IXE80Q4W/IXE80Q4W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Participants did not receive any intervention during Follow-up period
BG002
IXE80Q2W/IXE80Q2W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
Post-treatment Follow-up Period: Participants did not receive any intervention during Follow-up period
Participants did not receive any intervention during Follow-up period
BG003
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG000104
BG001114
BG00298
BG003316
Baseline Measures
Title
Description
Population Description
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Denominator Units Selected
Denominators
Classes
Age, Continuous
Mean
Standard Deviation
Years
Title
Denominators
Categories
Title
Measurements
BG00046.6± 12.72
BG00147.4± 13.36
BG00244.2± 10.79
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00017
BG00123
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00033
BG00132
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0004
BG0014
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
Puerto Rico
Title
Measurements
BG0001
BG0012
BG002
Type
Title
Description
Population Description
Reporting Status
Anticipated Posting Date
Parameter Type
Dispersion Type
Unit of Measure
Calculate Percentage
Time Frame
Units Analyzed
Denominator Units Selected
Arm/Group Information
Denominators
Classes
Analyses
Primary
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
ASAS40 is defined as improvement from baseline of greater than or equal to (>=) 40 % and absolute improvement from baseline of at least 2 units (range of 0 to 10) in at least 3 of the following 4 domains without any worsening in the remaining domain.
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
All randomized participants.
Posted
Number
Percentage of participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks (Q2W) by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG00012.5
OG00125.4
OG00230.6
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.017
Odds Ratio (OR)
2.41
2-Sided
95
1.17
4.95
Superiority
OG000
OG002
Regression, Logistic
0.003
Secondary
Percentage of Participants Achieving an ASAS20 Response
ASAS20 response is defined as a ≥20% improvement and an absolute improvement from baseline of ≥1 units (range 0 to 10) in ≥3 of 4 domains, and no worsening of ≥20% and ≥1 unit (range 0 to 10) in the remaining domain.
Patient Global: How active was your spondylitis on average during the last week? score ranges 0 (not active) to 10 (very active).
Spinal Pain: How much Pain of your spine due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain).
Bath Ankylosing Spondylitis Functional Index (BASFI): Participant asked to rate the difficulty associated with 10 individual basic functional activities. Participant response was captured using Numeric Rating Scale (NRS) (range 0 to 10) with a higher score indicating worse function.
Inflammation based on Q5 & Q6 mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) (mean of intensity & duration of stiffness): Score ranges from "0" (none) and "10" (very severe).
All randomized participants.
Posted
Number
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
Secondary
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in AS. 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 scores indicated higher disease activity. Least Square (LS) mean was determined by mixed-model repeated measures (MMRM) with treatment, geographic region, baseline CRP status, number of prior tumor necrosis factor inhibitor (TNFi), baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
Secondary
Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to radiographic axial spondyloarthritis (rad-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. BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
All randomized participants.
Posted
Number
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
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 radiographic axial spondyloarthritis (rad-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. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. The BASFI is composed with 10 questions to assess the disease severity, including the first 8 questions regarding to functional anatomy related activities and the remaining 2 questions related to daily activities of AS participants. Participants respond to each question using an NRS scale (range 0 to 10). The BASFI score is the average of the 10 responses and has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS mean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
Secondary
Percentage of Participants Achieving ASDAS Inactive Disease
ASDAS is a composite index to assess disease activity in AS. ASDAS Inactive Disease is defined as a score of <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.
Posted
Number
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Secondary
Percentage of Participants Achieving ASDAS <2.1
ASDAS is a composite index to assess disease activity in AS. ASDAS <2.1 defines moderate disease activity.
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.
Posted
Number
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Secondary
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores
The SF-36 is a 36-item participant 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 2 overarching domains of mental well- being and physical well-being are captured by the Mental Component Summary and Physical Component Summary scores. T-scores are used for analysis. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LSmean was determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
Secondary
Change From Baseline in ASAS Health Index (ASAS HI)
The ASAS Health Index (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 1 question that the patient needs to respond to with either "I agree" (score 1) or "I do not agree (score 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 determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Secondary
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)
The study used MRI with fat-saturating techniques such as short tau inversion recovery (STIR) to look for the presence of bone marrow edema. The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of the 23 disco-vertebral units (DVU) of the spine (from C2 to S1), capturing bone marrow edema. Scores for each DVU range from 0-3 (0=normal; 1=minor bone marrow edema [less than or equal to 25% of DVU; 3=severe bone marrow edema (more that 50% of DVU)]. The composite score ranges from 0 to 69, with higher scores reflecting worse disease.LS mean was determined by analysis of covariance (ANCOVA) with treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value as fixed factors.
All randomized participants with baseline and week 16 ASSpiMRI score.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
Secondary
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) were scored for bone marrow edema. A single DVU has 18 scoring units, and each has score of 0 or 1, bringing the maximum total score to 414, the sum ranges from 0 to 414 with higher scores reflecting worse disease. Scoring was performed by central readers. LS mean was determined by ANCOVA with factors for treatment, geographic region, baseline CRP status, number of prior TNF inhibitors used and baseline value.
All randomized participants with baseline and week 16 SPARCC MRI score.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High sensitivity CRP is the measure of acute phase reactant. It was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. High sensitivity CRP is a sensitive laboratory assay for serum levels of C-Reactive Protein, which is a biomarker of inflammation. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
milligram per liter (mg/L)
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
BASMI is a combined index comprising of 5 clinical measurements of spinal mobility in patients with radiographic axial spondyloarthritis (rad-axSpA).
Lateral Spinal Flexion
Tragus-to-wall distance
Lumbar Flexion (modified Schober)
Maximal intermalleolar distance and
Cervical rotation. The BASMI linear result is the average of the 5 assessments and ranges from 0 to 10. The higher the BASMI score the more severe the patient's limitation of movement due to their AS. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Secondary
Change From Baseline in Chest Expansion
Chest expansion is the difference, in centimeter (cm), between the circumference of the chest in maximal inspiration and maximal expiration. While patients have their hands resting on or behind the head, the assessor will measure the chest encircled length by centimeter (cm) at the fourth intercostal level anteriorly. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
centimeter(cm)
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
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 determined by MMRM with factors for treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
cm
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
The 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 include costochondral 1 (right/left), costochondral 7 (right/left), spinal iliaca anterior superior (right/left), crista iliaca (right/left), spina iliaca posterior (right/left), processus spinosus L5, and Achilles tendon proximal insertion (right/left). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline MASES score > 0.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Secondary
Change From Baseline in Spondyloarthritis Research Consortium of Canada (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 determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline SPARCC Enthesitis score > 0.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Tender Joint Count (TJC) Scores
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the body). The 46 joints were assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which was multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.
All randomized participants with baseline TJC > 0.
Posted
Least Squares Mean
Standard Error
Tender Joint Count
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC) Scores
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the body). The 44 joints were assessed and classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which was multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen). LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction.
All randomized participants with baseline SJC > 0.
Posted
Least Squares Mean
Standard Error
Swollen Joint Count
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Percentage 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.
Posted
Number
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
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 1 number that describes their worst level of fatigue during the previous 24 hours. LS mean was determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
The 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 determined by MMRM with treatment, geographic region, baseline CRP status, number of prior TNFi, baseline value, visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
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 determined by ANCOVA with treatment, geographic region, baseline CRP status, number of prior TNFi and baseline value as fixed factors.
All randomized participants with baseline and week 16 WPAI-SpA score.
Posted
Least Squares Mean
Standard Error
Units on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (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, higher the score greated the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
Participants from extended treatment period who had NSAID Intake at baseline.
Posted
Mean
Standard Deviation
Units on a scale
Baseline, Week 52
ID
Title
Description
OG000
PBO/IXE
Blinded Treatment Dosing Period: Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
Extended Treatment Period: Participants who received Placebo in blinded treatment period were re-randomized to receive ixekizumab 80 mg Q4W or 80 mg Q2W at a 1:1 ratio.
OG001
IXE80Q4W/IXE80Q4W
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
OG002
IXE80Q2W/IXE80Q2W
Secondary
Percentage of Participants With Anti-Ixekizumab Antibodies
A treatment emergent - antidrug antibody (TE-ADA) positive patient is defined as: a) a patient with a >= 4-fold increase over a positive baseline antibody titer; or b) for a negative baseline titer, a patient with an increase from the baseline to a level of >= 1:10. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants * 100%.
All randomized participants.
Posted
Number
Percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every 2 weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab by SC injection at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W).
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Secondary
Pharmacokinetics (PK): Trough Ixekizumab Concentration at Steady State (Ctrough ss)
Pharmacokinetics (PK): Steady-state trough serum concentration of Ixekizumab at week 16.
All randomized participants who received study drug and have evaluable PK data.
Posted
Geometric Mean
Geometric Coefficient of Variation
Microgram per milliliters (µg/mL)
Week 16
ID
Title
Description
OG000
80 mg Q4W Ixekizumab (Starting Dose 80 mg)
Participants received 80 mg of Ixekizumab every four weeks by subcutaneous injection.
OG001
80 mg Q4W Ixekizumab (Starting Dose 160 mg)
Participants received 160 mg ixekizumab at baseline followed by 80 mg ixekizumab given SC every four weeks by subcutaneous injection.
OG002
80 mg Q2W Ixekizumab (Starting Dose 80 mg)
Participants received 80 mg ixekizumab every two weeks by subcutaneous injection.
OG003
80 mg Q2W Ixekizumab (Starting Dose 160 mg)
Participants received starting dose of 160 mg ixekizumab at baseline followed by 80 mg ixekizumab every two weeks by subcutaneous injection.
Time Frame
Up To 76 Weeks
Description
All randomized participants. There are gender specific adverse events, only occurring in male or female participants. The number of participants exposed has been 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
80 mg Q2W Ixekizumab-Blinded Treatment Period
Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
1
98
3
98
25
98
EG001
80 mg Q4W Ixekizumab-Blinded Treatment Period
Participants received starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) up to week 16.
0
114
4
114
25
114
EG002
PBO-Blinded Treatment Period
Participants received placebo every two weeks (Q2W) by subcutaneous (SC) injection during Week 0 to 16.
0
104
5
104
12
104
EG003
IXE80Q2W/IXE80Q2W-Extended Treatment Period
Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.
0
90
1
90
26
90
EG004
IXE80Q4W/IXE80Q4W-Extended Treatment Period
Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
0
98
2
98
19
98
EG005
PBO/IXE-Extended Treatment Period
Participants received 80 mg ixekizumab given SC Q4W from week 16 to week 52.
0
93
6
93
19
93
EG006
IXE80Q2W-Follow-up Period
Participants did not receive any intervention during post-treatment follow-up period.
0
22
1
22
1
22
EG007
IXE80Q4W-Follow-up Period
Participants did not receive any intervention during post-treatment follow-up period.
0
34
2
34
3
34
EG008
PBO-Follow-up Period
Participants did not receive any intervention during post-treatment follow-up period.
0
5
0
5
1
5
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Acute myocardial infarction
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG0030 events0 affected90 at risk
EG0040 events0 affected98 at risk
EG0051 events1 affected93 at risk
EG0060 events0 affected22 at risk
EG0070 events0 affected34 at risk
EG0080 events0 affected5 at risk
Atrial tachycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Bradycardia
Cardiac disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Colitis ulcerative
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0021 events1 affected104 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Inguinal hernia
Gastrointestinal disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0021 events1 affected104 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Peritonitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Pharyngitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Pneumonia
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Sinusitis
Infections and infestations
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Femur fracture
Injury, poisoning and procedural complications
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0021 events1 affected104 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 22.0
Systematic Assessment
EG0001 events1 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Hyperkalaemia
Metabolism and nutrition disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0022 events1 affected104 at risk
EG003
Fracture pain
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0011 events1 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Acute promyelocytic leukaemia
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 22.0
Systematic Assessment
EG0000 events0 affected98 at risk
EG0010 events0 affected114 at risk
EG0020 events0 affected104 at risk
EG003
Lung adenocarcinoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG00029.8
OG00148.2
OG00246.9
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.006
Odds Ratio (OR)
2.20
2-Sided
95
1.26
3.84
Superiority
OG000
OG002
Regression, Logistic
0.013
Odds Ratio (OR)
2.08
2-Sided
95
1.16
3.73
Superiority
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-0.11± 0.099
OG001-1.16± 0.094
OG002-1.13± 0.103
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 (Final Values)
-1.05
Standard Error of the Mean
0.135
2-Sided
95
-1.32
-0.79
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference (Final Values)
-1.03
Standard Error of the Mean
0.140
2-Sided
95
-1.30
-0.75
Superiority
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0009.6
OG00121.9
OG00223.5
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
0.015
Odds Ratio (OR)
2.65
2-Sided
95
1.21
5.84
Superiority
OG000
OG002
Regression, Logistic
0.010
Odds Ratio (OR)
2.90
2-Sided
95
1.29
6.49
Superiority
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-0.92± 0.212
OG001-2.17± 0.202
OG002-2.09± 0.221
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 (Final Values)
-1.24
Standard Error of the Mean
0.291
2-Sided
95
-1.81
-0.67
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference (Final Values)
-1.16
Standard Error of the Mean
0.301
2-Sided
95
-1.76
-0.57
Superiority
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-0.64± 0.215
OG001-1.69± 0.205
OG002-1.92± 0.225
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 (Final Values)
-1.05
Standard Error of the Mean
0.295
2-Sided
95
-1.63
-0.47
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference (Final Values)
-1.28
Standard Error of the Mean
0.307
2-Sided
95
-1.89
-0.68
Superiority
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0001.0
OG0013.5
OG0025.1
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
0.242
Odds Ratio (OR)
3.73
2-Sided
95
0.41
33.98
Superiority
OG000
OG002
Regression, Logistic
0.127
Odds Ratio (OR)
5.42
2-Sided
95
0.62
47.54
Superiority
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0004.8
OG00117.5
OG00216.3
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
0.006
Odds Ratio (OR)
4.22
2-Sided
95
1.50
11.86
Superiority
OG000
OG002
Regression, Logistic
0.006
Odds Ratio (OR)
4.52
2-Sided
95
1.55
13.18
Superiority
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
SF-36 MCS
Title
Measurements
OG0002.7410± 0.9452
OG0013.5099± 0.9074
OG0023.6514± 0.9921
SF-36 PCS
Title
Measurements
OG0001.3638± 0.8146
OG0016.5785± 0.7763
OG0026.1223± 0.8465
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
MCS
Mixed Models Analysis
0.550
LS Mean Difference (Final Values)
0.7689
Standard Error of the Mean
1.2863
2-Sided
95
-1.7629
3.3007
Superiority
OG000
OG002
MCS
Mixed Models Analysis
0.495
LS Mean Difference (Final Values)
0.9104
Standard Error of the Mean
1.3338
2-Sided
95
-1.7151
3.5360
Superiority
OG000
OG001
PCS
Mixed Models Analysis
<0.001
LS Mean Difference (Final Values)
5.2147
Standard Error of the Mean
1.1149
2-Sided
95
3.0204
7.4090
Superiority
OG000
OG002
PCS
Mixed Models Analysis
<0.001
LS Mean Difference (Final Values)
4.7585
Standard Error of the Mean
1.1505
2-Sided
95
2.4940
7.0230
Superiority
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-0.89± 0.338
OG001-1.92± 0.322
OG002-1.58± 0.352
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
0.026
LS Mean Difference (Final Values)
-1.03
Standard Error of the Mean
0.460
2-Sided
95
-1.94
-0.13
Superiority
OG000
OG002
Mixed Models Analysis
0.149
LS Mean Difference (Final Values)
-0.69
Standard Error of the Mean
0.477
2-Sided
95
-1.63
0.25
Superiority
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG00046
OG00149
OG00245
Title
Denominators
Categories
Title
Measurements
OG0001.03± 0.379
OG001-0.92± 0.373
OG002-1.14± 0.414
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 (Final Values)
-1.95
Standard Error of the Mean
0.512
2-Sided
95
-3.0
-0.9
Superiority
OG000
OG002
ANCOVA
<0.001
LS Mean Difference (Final Values)
-2.17
Standard Error of the Mean
0.534
2-Sided
95
-3.2
-1.1
Superiority
Units
Counts
Participants
OG00046
OG00149
OG00245
Title
Denominators
Categories
Title
Measurements
OG0003.29± 1.402
OG001-2.99± 1.384
OG002-3.97± 1.534
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 (Final Values)
-6.29
Standard Error of the Mean
1.896
2-Sided
95
-10.0
-2.5
Superiority
OG000
OG002
ANCOVA
<0.001
LS Mean Difference (Final Values)
-7.27
Standard Error of the Mean
1.978
2-Sided
95
-11.2
-3.4
Superiority
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0009.719± 2.7383
OG001-11.096± 2.6190
OG002-8.121± 2.8829
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 (Final Values)
-20.816
Standard Error of the Mean
3.7463
2-Sided
95
-28.187
-13.444
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LS Mean Difference (Final Values)
-17.841
Standard Error of the Mean
3.9018
2-Sided
95
-25.518
-10.163
Superiority
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-0.046± 0.0939
OG001-0.349± 0.0897
OG002-0.217± 0.0981
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 (Final Values)
-0.304
Standard Error of the Mean
0.1275
2-Sided
95
-0.555
-0.053
Superiority
OG000
OG002
Mixed Models Analysis
0.194
LS Mean Difference (Final Values)
-0.172
Standard Error of the Mean
0.1319
2-Sided
95
-0.431
0.088
Superiority
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0000.04± 0.644
OG0011.27± 0.618
OG0020.27± 0.655
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
0.170
LS Mean Difference (Final Values)
1.23
Standard Error of the Mean
0.893
2-Sided
95
-0.53
2.99
Superiority
OG000
OG002
Mixed Models Analysis
0.800
LS Mean Difference (Final Values)
0.23
Standard Error of the Mean
0.916
2-Sided
95
-1.57
2.04
Superiority
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0000.35± 0.384
OG0010.03± 0.365
OG002-0.65± 0.399
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
0.547
LS Mean Difference (Final Values)
-0.31
Standard Error of the Mean
0.521
2-Sided
95
-1.34
0.71
Superiority
OG000
OG002
Mixed Models Analysis
0.064
LS Mean Difference (Final Values)
-1.00
Standard Error of the Mean
0.538
2-Sided
95
-2.06
0.06
Superiority
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG00069
OG00182
OG00274
Title
Denominators
Categories
Title
Measurements
OG000-1.9± 0.43
OG001-1.8± 0.40
OG002-2.2± 0.42
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
0.861
LS Mean Difference (Final Values)
0.1
Standard Error of the Mean
0.58
2-Sided
95
-1.0
1.3
Superiority
OG000
OG002
Mixed Models Analysis
0.626
LS Mean Difference (Final Values)
-0.3
Standard Error of the Mean
0.59
2-Sided
95
-1.4
0.9
Superiority
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG00060
OG00178
OG00264
Title
Denominators
Categories
Title
Measurements
OG000-1.9± 0.44
OG001-2.3± 0.40
OG002-1.8± 0.45
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
0.504
LS Mean Difference (Final Values)
-0.4
Standard Error of the Mean
0.59
2-Sided
95
-1.6
0.8
Superiority
OG000
OG002
Mixed Models Analysis
0.860
LS Mean Difference (Final Values)
0.1
Standard Error of the Mean
0.62
2-Sided
95
-1.1
1.3
Superiority
Units
Counts
Participants
OG00065
OG00185
OG00269
Title
Denominators
Categories
Title
Measurements
OG000-3.9± 0.79
OG001-4.8± 0.69
OG002-5.0± 0.79
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
0.362
LS Mean Difference (Final Values)
-0.9
Standard Error of the Mean
1.03
2-Sided
95
-3.0
1.1
Superiority
OG000
OG002
Mixed Models Analysis
0.303
LS Mean Difference (Final Values)
-1.1
Standard Error of the Mean
1.08
2-Sided
95
-3.3
1.0
Superiority
Units
Counts
Participants
OG00045
OG00148
OG00244
Title
Denominators
Categories
Title
Measurements
OG000-2.4± 0.51
OG001-2.6± 0.49
OG002-3.0± 0.54
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
0.813
LS Mean Difference (Final Values)
-0.2
Standard Error of the Mean
0.70
2-Sided
95
-1.5
1.2
Superiority
OG000
OG002
Mixed Models Analysis
0.410
LS Mean Difference (Final Values)
-0.6
Standard Error of the Mean
0.71
2-Sided
95
-2.0
0.8
Superiority
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG0000
OG0011.8
OG0023.1
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-0.7± 0.24
OG001-2.0± 0.23
OG002-1.7± 0.25
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 (Final Values)
-1.2
Standard Error of the Mean
0.33
2-Sided
95
-1.9
-0.6
Superiority
OG000
OG002
Mixed Models Analysis
0.005
LS Mean Difference (Final Values)
-1.0
Standard Error of the Mean
0.34
2-Sided
95
-1.6
-0.3
Superiority
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG000104
OG001114
OG00298
Title
Denominators
Categories
Title
Measurements
OG000-1.8± 0.50
OG001-3.0± 0.48
OG002-2.4± 0.52
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
0.088
LS Mean Difference (Final Values)
-1.2
Standard Error of the Mean
0.68
2-Sided
95
-2.5
0.2
Superiority
OG000
OG002
Mixed Models Analysis
0.366
LS Mean Difference (Final Values)
-0.6
Standard Error of the Mean
0.70
2-Sided
95
-2.0
0.7
Superiority
OG002
80 mg Q2W Ixekizumab
Participants received starting dose of 80 or 160 mg ixekizumab given SC injection at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 16.
Units
Counts
Participants
OG00099
OG001112
OG00296
Title
Denominators
Categories
Overall Work Impairment Score
ParticipantsOG00054
ParticipantsOG00144
ParticipantsOG00243
Title
Measurements
OG000-9.84± 3.733
OG001-20.97± 4.016
OG002-23.50± 4.225
Percentage of Activity Impairment
ParticipantsOG00099
ParticipantsOG001112
ParticipantsOG00296
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
Overall Work Impairment Score
ANCOVA
0.038
LS Mean Difference (Final Values)
-11.13
Standard Error of the Mean
5.323
2-Sided
95
-21.65
-0.60
Superiority
OG000
OG002
Overall Work Impairment Score
ANCOVA
0.012
LS Mean Difference (Final Values)
-13.66
Standard Error of the Mean
5.341
2-Sided
95
-24.23
-3.10
Superiority
OG000
OG001
Percentage of Activity Impairment
ANCOVA
0.071
LS Mean Difference (Final Values)
-6.3
Standard Error of the Mean
3.50
2-Sided
95
-13.2
0.5
Superiority
OG000
OG002
Percentage of Activity Impairment
ANCOVA
0.024
LS Mean Difference (Final Values)
-8.3
Standard Error of the Mean
3.65
2-Sided
95
-15.5
-1.1
Superiority
Blinded Treatment Dosing Period: Participants received starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) up to week 16.
Extended Treatment Period: Participants received 80 mg ixekizumab given SC Q2W from week 16 to week 52.