A Study of Ixekizumab (LY2439821) in bDMARD-Naive Partici... | NCT02696785 | Trialant
NCT02696785
Sponsor
Eli Lilly and Company
Status
Completed
Last Update Posted
Nov 19, 2019Actual
Enrollment
341Actual
Phase
Phase 3
Conditions
Spondyloarthritis
Interventions
Ixekizumab
Placebo
Adalimumab
Countries
United States
Czechia
Germany
Japan
Netherlands
South Korea
Taiwan
Protocol Section
Identification Module
NCT ID
NCT02696785
Obsolete or Duplicate NCT IDs
Not provided
Organization Study
16178
Secondary IDs
ID
Type
Description
Link
I1F-MC-RHBV
Other Identifier
Eli Lilly and Company
2015-003932-11
EudraCT Number
Brief Title
A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
Official Title
A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis
Acronym
COAST-V
Organization
Eli Lilly and CompanyINDUSTRY
Status Module
Record Verification Date
Nov 2018
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
May 2, 2016Actual
Primary Completion Date
Dec 8, 2017Actual
Completion Date
Oct 17, 2018Actual
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 31, 2019
Results First Posted Date
Nov 19, 2019Actual
Certification/Extension (aka Delayed Results) First Submitted Date
Jun 4, 2018
Certification/Extension First Submitted that Passed QC Review
Jun 4, 2018
Certification/Extension First Posted Date
Jun 8, 2018Actual
Last Update Submitted Date
Oct 31, 2019
Last Update Posted Date
Nov 19, 2019Actual
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
Eli Lilly and CompanyINDUSTRY
Collaborators
Not provided
Oversight Module
Has Data Monitoring Committee (DMC)
No
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
Brief Summary
The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive 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
341Actual
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: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.
Drug: Ixekizumab
Drug: Placebo
Adalimumab
Active Comparator
Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14.
Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.
Drug: Ixekizumab
Drug: Adalimumab
Interventions
Name
Type
Description
Arm Group Labels
Other Names
Ixekizumab
Drug
Administered SC
Adalimumab
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 in at least 3 of the following 4 domains without any worsening in the remaining domains.
Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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 in ≥3 of 4 following 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 range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using NRS scale (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.
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.
In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.
Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.
Exclusion Criteria:
Have total ankylosis of the spine.
Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
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)
Sengupta R, Machado PM, Goupille P, Rudwaleit M, Sheesh M, Ng KJ, Ngantcha M, Yan Y, Russ H, Doridot G, Xue Y, Poddubnyy D, Baraliakos X, Navarro-Compan V. Efficacy of Ixekizumab in Radiographic Axial Spondyloarthritis by Baseline C-Reactive Protein Level: A Pooled Analysis of Phase III Trials. Rheumatol Ther. 2026 Jun 2. doi: 10.1007/s40744-026-00862-1. Online ahead of print.
Click here for more information about this study: A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis (COAST-V)
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 (Study I1F-MC-RHBY [RHBY]) for up to 2 additional years. Participants that do not enroll into study RHBY will complete the Post-Treatment Follow-Up Period.
Recruitment Details
Blinded treatment period (Week 0 to Week 16), followed by extended treatment period (Week 16 to Week 52), followed by post treatment period for a maximum of 24 weeks.
Washout period occurred for only Adalimumab group for 6 weeks (Week 14 to Week 20).
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
FG000
PBO/IXE
Blinded Treatment Period: Participants received placebo every two weeks by subcutaneous injection.
Extended Treatment Period: Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either every two weeks (Q2W) or every four weeks (Q4W) by subcutaneous (SC) injection during extended treatment period.
Participants did not receive any intervention during Follow-up period.
Periods
Title
Milestones
Reasons Not Completed
Blinded Treatment Period
Type
Comment
Milestone Data
STARTED
Baseline Characteristics Module
Baseline Analysis Population Description
Outcome Measures Module
Outcome Measures
Adverse Events Module
Frequency Threshold
5
More Info Module
Limitations and Caveats
Not provided
Annotation Section
No data available
No data is available for this block.
Document Section
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
Dec 23, 2016
Oct 24, 2019
Derived Section
Miscellaneous Info Module
Version Holder
Jul 10, 2026
Removed Countries
Canada
Hungary
Italy
Mexico
Poland
Russia
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
Adalimumab
Drug
Administered SC
Adalimumab
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 the following:
Total back pain
Patient global
Peripheral pain/swelling
Duration of morning stiffness
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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm.
Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) model with treatment, geographic region, baseline CRP status, 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 measuring discomfort, pain, and fatigue. 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).
BASDAI50 represents an improvement of ≥50% of the BASDAI score from baseline.
Week 16
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI is a participant-reported assessment that establishes a participants functional baseline and subsequent response to treatment. To complete the BASFI, a participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants respond to each question using an NRS scale (range 0 to 10) with a higher score indicating worse function. The participants final BASFI score is the mean of the 10 item scores has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following:
Total back pain
Patient global
Peripheral pain/swelling
Duration of morning stiffness
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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. ASDAS Inactive Disease is defined as a score of <1.3.
Week 16
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)
The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of 23 disco-vertebral units (DVU). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) are scored for 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.
Least Squares (LS) Mean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
Baseline, 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 calculated using MMRM model with treatment, geographic region, baseline CRP status, 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)
ASAS HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors
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 will be measured with a high sensitivity assay at the central laboratory to help assess the effect of Ixekizumab on disease activity.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, visit and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)
The BASMI is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with rad-axSpA.
Lateral spinal flexion
Tragus-to-wall distance
Lumbar flexion (modified Schrober)
Maximal intermalleolar distance
Cervical rotation. The BASMI includes these 5 measurements that are each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. The higher the BASMI score the more severe the participants limitation of movement due to their AS.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in Chest Expansion
While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Both left and right SIJ are scored for bone marrow edema.Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease.
LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value 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.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Change From Baseline in SPARCC Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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 (TJC)
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body. The 46 joints are assessed and classified as tender or not tender. sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful).
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Baseline, Week 16
Number of Participants With Anterior Uveitis or Uveitis Flares
Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Baseline through Week 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 one number that describes their worst level of fatigue during the previous 24 hours.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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 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. Participants report the number 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.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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. Greater scores indicate greater impairment and less productivity.
LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status 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).. ASAS-NSAID score=(equivalent NSAID score)x(days of intake during PI)x(days per week)/(PI in days). Higher scores indicate greater NSAIDs intake. 0= no intake, 100 = equivalent NSAID intake.
Baseline, Week 52
Number 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.
Week 16
Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss)
Week 16
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC)
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the participants body. The 44 joints are assessed and classified as swollen or not swollen. "sum of all joints checked to be swollen" divided by "number of evaluable joints" and then multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen).
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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 (Spondyloarthritis Research Consortium of Canada [SPARCC] Score)
MRI score of spine was assessed using SPARCC method. All 23 disco-vertebral units (DVUs) of the spine (from C2 to S1) are scored for bone marrow edema. A single DVU has a scoring range of 0 to 18, bringing the maximum total score to 414, with higher scores reflecting worse disease. Scoring was performed by central readers.
LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors
Baseline, Week 16
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
New England Research Associates
Trumbull
Connecticut
06611
United States
Sarasota Arthritis Center
Sarasota
Florida
34239
United States
Marietta Rheumatology
Marietta
Georgia
30060
United States
Center for Arthritis & Osteoporosis
Elizabethtown
Kentucky
42701
United States
Klein and Associates MD, PA
Cumberland
Maryland
21502
United States
Klein and Associates MD, PA
Hagerstown
Maryland
21740
United States
Arthritis Consultants
St Louis
Missouri
63141
United States
Glacier View Research Institute
Kalispell
Montana
59901
United States
Physician Research Collaboration, LLC
Lincoln
Nebraska
68516
United States
Shanahan Rheumatology & Immunotherapy
Raleigh
North Carolina
27617
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
Arthritis Northwest Rheumatology
Spokane
Washington
99204
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.
Brno
611 41
Czechia
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.
Berlin
12203
Germany
"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
Hyōgo
366 8501
Japan
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.
Warszawa
02-691
Netherlands
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.
Gwangjin-gu
05080
South Korea
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.
Seoul
04763
South Korea
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.
Taichung
40201
Taiwan
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.
Taichung
40447
Taiwan
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.
Taipei
10048
Taiwan
Derived
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.
Navarro-Compan V, Reveille JD, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Panni T, Kronbergs A, Rudwaleit M. Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration. Adv Ther. 2025 Sep;42(9):4706-4716. doi: 10.1007/s12325-025-03305-5. Epub 2025 Jul 22.
Maksymowych WP, Lambert RGW, Bolce RJ, Bello N, Zhu B, Lisse JR, Ostergaard M. The effect of ixekizumab treatment on MRI sacroiliac joint structural lesions in patients with radiographic axial spondyloarthritis: post-hoc analysis of a 52-week, randomised, placebo-controlled trial with an active reference arm. Lancet Rheumatol. 2025 May;7(5):e314-e322. doi: 10.1016/S2665-9913(24)00312-6. Epub 2025 Feb 18.
Ramiro S, Lukas C, Nissen MJ, Zhu B, Ng KJ, Sheesh M, Doridot G, Liu-Leage S, Chan A, Fang Y, Wei JC. Improvement in spinal pain at night and its impact on long-term outcomes in radiographic axial spondyloarthritis: Results from Ixekizumab COAST-V randomised trial. Semin Arthritis Rheum. 2024 Dec;69:152571. doi: 10.1016/j.semarthrit.2024.152571. Epub 2024 Oct 23.
de Vlam K, Maksymowych WP, Gallo G, Rahman P, Mease P, Krishnan V, McVeigh CJ, Lisse J, Zhu D, Bolce RJ, Conaghan PG. Exploring the Effects of Ixekizumab on Pain in Patients with Ankylosing Spondylitis Based on Objective Measures of Inflammation: Post Hoc Analysis from a Large Randomized Clinical Trial. Rheumatol Ther. 2024 Jun;11(3):691-707. doi: 10.1007/s40744-024-00660-7. Epub 2024 Apr 18.
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.
Mease P, Walsh JA, Baraliakos X, Inman R, de Vlam K, Wei JC, Hunter T, Gallo G, Sandoval D, Zhao F, Dong Y, Bolce R, Marzo-Ortega H. Translating Improvements with Ixekizumab in Clinical Trial Outcomes into Clinical Practice: ASAS40, Pain, Fatigue, and Sleep in Ankylosing Spondylitis. Rheumatol Ther. 2019 Sep;6(3):435-450. doi: 10.1007/s40744-019-0165-3. Epub 2019 Jun 28.
FG001
ADA/PBO/IXE
Blinded Treatment Period:Participants received 40mg Adalimumab every two weeks by SC injection.
Washout Period: Participants received placebo for 6 weeks. Extended Treatment Period:Participants received 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period.
Participants did not receive any intervention during Follow-up period.
FG002
IXE80Q2W/IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded & extension treatment period.
Participants did not receive any intervention during Follow-up period.
FG003
IXE80Q4W/IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded & extension treatment period.
Participants did not receive any intervention during Follow-up period.
FG00087 subjects
FG00190 subjects
FG00283 subjects
FG00381 subjects
Received at Least One Dose of Study Drug
FG00086 subjects
FG00190 subjects
FG00283 subjects
FG00381 subjects
COMPLETED
FG00086 subjects
FG00188 subjects
FG00279 subjects
FG00378 subjects
NOT COMPLETED
FG0001 subjects
FG0012 subjects
FG0024 subjects
FG0033 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0011 subjects
FG0023 subjects
FG0030 subjects
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0021 subjects
FG0032 subjects
Lack of Efficacy
FG0000 subjects
FG0010 subjects
FG0020 subjects
FG0031 subjects
Screen Failure
FG0001 subjects
FG0010 subjects
FG0020 subjects
FG0030 subjects
Washout Period
Type
Comment
Milestone Data
STARTED
FG0000 subjectsWashout period occurred only for Adalimumab group.
FG00188 subjects
FG0020 subjectsWashout period occurred only for Adalimumab group.
FG0030 subjectsWashout period occurred only for Adalimumab group.
COMPLETED
FG0000 subjects
FG00186 subjects
FG0020 subjects
FG0030 subjects
NOT COMPLETED
FG0000 subjects
FG0012 subjects
FG0020 subjects
FG0030 subjects
Type
Comment
Reasons
Withdrawal by Subject
FG0000 subjects
FG0011 subjects
FG0020 subjects
FG003
Extended Treatment Period
Type
Comment
Milestone Data
STARTED
FG00086 subjects
FG00186 subjects
FG00279 subjects
FG00378 subjects
COMPLETED
FG00083 subjects
FG00180 subjects
FG00274 subjects
FG00372 subjects
NOT COMPLETED
FG0003 subjects
FG0016 subjects
FG0025 subjects
FG0036 subjects
Type
Comment
Reasons
Adverse Event
FG0002 subjects
FG0013 subjects
FG0022 subjects
FG003
Follow-up Period
Type
Comment
Milestone Data
STARTED
FG0001 subjectsParticipants who completed study were eligible to enroll RHBY \& who didn't enroll entered Follow-Up.
FG0010 subjectsParticipants who completed study were eligible to enroll RHBY \& who didn't enroll entered Follow-Up.
FG00224 subjectsParticipants who completed study were eligible to enroll RHBY \& who didn't enroll entered Follow-Up.
FG00316 subjectsParticipants who completed study were eligible to enroll RHBY \& who didn't enroll entered Follow-Up.
COMPLETED
FG0000 subjects
FG0010 subjects
FG00211 subjects
FG0038 subjects
NOT COMPLETED
FG0001 subjects
FG0010 subjects
FG00213 subjects
FG0038 subjects
Type
Comment
Reasons
Adverse Event
FG0000 subjects
FG0010 subjects
FG0028 subjects
FG003
All randomized participants who received at least one dose of study drug.
Type of Units Analyzed
Not provided
Arm/Group Information
ID
Title
Description
BG000
PBO/IXE
Participants received placebo every two weeks by subcutaneous injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by subcutaneous injection during extension treatment period.
BG001
ADA/IXE
Participants received 40mg Adalimumab every two weeks by SC injection during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W by SC injection during extension treatment period.
BG002
IXE80Q2W/IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection during blinded & extension treatment period.
BG003
IXE80Q4W/IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection during blinded & extension treatment period.
BG004
Total
Total of all reporting groups
Denominators
Units
Counts
Participants
BG00086
BG00190
BG00283
BG00381
BG004340
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
BG00042.7± 12.01
BG00141.8± 11.44
BG00241.3± 11.17
BG003
Sex: Female, Male
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Female
BG00015
BG00117
BG002
Ethnicity (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
Hispanic or Latino
BG00011
BG0017
BG002
Race (NIH/OMB)
Count of Participants
Participants
No
Title
Denominators
Categories
Title
Measurements
American Indian or Alaska Native
BG0004
BG0012
BG002
Region of Enrollment
Count of Participants
Participants
No
Title
Denominators
Categories
South Korea
Title
Measurements
BG00010
BG00114
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 in at least 3 of the following 4 domains without any worsening in the remaining domains.
Patient Global: How active was your spondylitis on average during the last week? score range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using numeric rating scale (NRS) scale (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 two weeks by subcutaneous injection.
OG001
Adalimumab
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG003
Title
Denominators
Categories
Title
Measurements
OG00018.4
OG00135.6
OG00248.1
OG003
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
Regression, Logistic
0.005
Odds Ratio (OR)
2.73
2-Sided
95
1.35
5.52
Superiority
OG000
OG002
Overall Work Impairment Score.
Regression, Logistic
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 in ≥3 of 4 following 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 range 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: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants response is captured using NRS scale (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 two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
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 the following:
Total back pain
Patient global
Peripheral pain/swelling
Duration of morning stiffness
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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm.
Least Square (LS) Mean was calculated using mixed model repeated measures (MMRM) model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
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 measuring discomfort, pain, and fatigue. 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).
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 two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Secondary
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
The BASFI is a participant-reported assessment that establishes a participants functional baseline and subsequent response to treatment. To complete the BASFI, a participant is asked to rate the difficulty associated with 10 individual basic functional activities. Participants respond to each question using an NRS scale (range 0 to 10) with a higher score indicating worse function. The participants final BASFI score is the mean of the 10 item scores has a possible minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Secondary
Percentage of Participants Achieving ASDAS Inactive Disease
ASDAS is a composite index to assess disease activity in AS. The parameters used for the ASDAS (with CRP as acute phase reactant) are the following:
Total back pain
Patient global
Peripheral pain/swelling
Duration of morning stiffness
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 to 10.Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. ASDAS Inactive Disease is defined as a score of <1.3.
All randomized participants.
Posted
Number
percentage of Participants
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Secondary
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score)
The Berlin modification of Ankylosing Spondylitis spine MRI score for activity (ASspiMRI) scoring technique assesses inflammation in each of 23 disco-vertebral units (DVU). All 23 disco-vertebral units (DVU) of the spine (from C2 to S1) are scored for 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.
Least Squares (LS) Mean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
All randomized participants with baseline and week 16 Berlin score.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
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 calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Secondary
Change From Baseline in ASAS Health Index (ASAS HI)
ASAS HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
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 will be measured with a high sensitivity assay at the central laboratory to help assess the effect of Ixekizumab on disease activity.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, visit and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
Milliragm per Litre (mg/mL)
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Secondary
Change From Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI)
The BASMI is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with rad-axSpA.
Lateral spinal flexion
Tragus-to-wall distance
Lumbar flexion (modified Schrober)
Maximal intermalleolar distance
Cervical rotation. The BASMI includes these 5 measurements that are each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. The higher the BASMI score the more severe the participants limitation of movement due to their AS.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Secondary
Change From Baseline in Chest Expansion
While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All Randomized Participants.
Posted
Least Squares Mean
Standard Error
Centimeters (cm)
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
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.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, 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 two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
Secondary
Change From Baseline in MRI Sacroiliac Joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Both left and right SIJ are scored for bone marrow edema.Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease.
LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
All randomized participants with baseline and week 16 SPARCC score.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
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.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline MASES score > 0.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Secondary
Change From Baseline in SPARCC Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline SPARCC score > 0.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC)
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body. The 46 joints are assessed and classified as tender or not tender. sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful).
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline TJC > 0.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Secondary
Number of Participants With Anterior Uveitis or Uveitis Flares
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
Count of Participants
Baseline through Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Secondary
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
The Fatigue Severity NRS is a participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Secondary
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
The 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. Participants report the number 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.
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
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. Greater scores indicate greater impairment and less productivity.
LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors.
All randomized participants.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
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).. ASAS-NSAID score=(equivalent NSAID score)x(days of intake during PI)x(days per week)/(PI in days). Higher scores indicate greater NSAIDs intake. 0= no intake, 100 = equivalent NSAID intake.
Participants in Extended Treatment Period Population Who had NSAID Intake at Baseline.
Posted
Mean
Standard Deviation
score on a scale
Baseline, Week 52
ID
Title
Description
OG000
Placebo/Ixekizumab
Participants received placebo every two weeks during blinded treatment period and starting dose of 160mg Ixekizumab at week 16 followed by 80mg Ixekizumab either Q2W or Q4W extended treatment period by subcutaneous injection.
OG001
Adalimumab/Ixekizumab
Participants received 40mg Adalimumab every two weeks during blinded treatment period and 80mg Ixekizumab either Q2W or Q4W during extended treatment period by subcutaneous injection.
OG002
Ixekizumab Q4W/Ixekizumab Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks during blinded treatment and extension period by subcutaneous injection.
Secondary
Number 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.
All randomized participants.
Posted
Count of Participants
Participants
No
Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Secondary
Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss)
All randomized participants who received at least one dose of Ixekizumab.
Posted
Geometric Mean
Geometric Coefficient of Variation
microgram per millilitre (μg/mL)
Week 16
ID
Title
Description
OG000
IXE80Q4W
Participants received 80mg Ixekizumab every four weeks by subcutaneous injection.
OG001
IXE160/80Q4W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG002
IXE80Q2W
Participants received 80mg Ixekizumab every two weeks by subcutaneous injection.
OG003
IXE160/80Q2W
Participants received starting dose of 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Secondary
Change From Baseline in Severity of Peripheral Arthritis by Swollen Joint Count (SJC)
The number of swollen joints was determined by examination of 44 joints (22 joints on each side of the participants body. The 44 joints are assessed and classified as swollen or not swollen. "sum of all joints checked to be swollen" divided by "number of evaluable joints" and then multiplied by 44 to obtain SJC score. The SJC score ranges from 0 (no swollen joints) to 44 (all joints swollen).
LSMean was calculated using MMRM model with treatment, geographic region, baseline CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
All randomized participants with baseline SJC > 0.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab 40mg
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
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 (DVUs) of the spine (from C2 to S1) are scored for bone marrow edema. A single DVU has a scoring range of 0 to 18, bringing the maximum total score to 414, with higher scores reflecting worse disease. Scoring was performed by central readers.
LSMean was calculated using ANCOVA model with treatment, geographic region, baseline CRP status and baseline value as fixed factors
All randomized participants with baseline and week 16 SPARCC MRI score for spine.
Posted
Least Squares Mean
Standard Error
score on a scale
Baseline, Week 16
ID
Title
Description
OG000
Placebo
Participants received placebo every two weeks by subcutaneous injection.
OG001
Adalimumab
Participants received 40mg Adalimumab every two weeks by SC injection.
OG002
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
Time Frame
Upto 76 Weeks
Description
All randomized participants who received at least one dose of study drug. 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
Placebo - Blinded Treatment
Participants received placebo every two weeks by subcutaneous injection.
0
86
0
86
12
86
EG001
Adalimumab 40mg - Blinded Treatment
Participants received 40mg Adalimumab every two weeks by SC injection.
0
90
3
90
16
90
EG002
IXE80Q2W - Blinded Treatment
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
0
83
1
83
18
83
EG003
IXE80Q4W - Blinded Treatment
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
0
81
1
81
11
81
EG004
ADA/PBO - Washout Treatment Period
Participants received placebo by subcutaneous injection
0
88
0
88
8
88
EG005
PBO/IXE - Extended Treatment Period
Participants received starting dose of 160mg Ixekizumab at week 16 followed by 80mg Q2W or 80mg Q4W by subcutaneous injection.
0
86
4
86
26
86
EG006
ADA/PBO/IXE - Extended Treatment Period
Participants received 80mg Ixekizumab Q2W or 80mg Q4W by subcutaneous injection.
0
86
7
86
20
86
EG007
IXE80Q2W/IXE80Q2W - Extended Treatment
Participants received 80mg Ixekizumab every two weeks by subcutaneous injection.
0
79
3
79
21
79
EG008
IXE80Q4W/IXE80Q4W - Extended Treatment
Participants received 80mg Ixekizumab every four weeks by subcutaneous injection.
0
78
4
78
14
78
EG009
PBO-follow-up Period
Participants did not receive any intervention.
0
1
0
1
1
1
EG010
IXE80Q2W-follow-up Period
Participants did not receive any intervention.
0
24
0
24
2
24
EG011
IXE80Q4W-follow-up Period
Participants did not receive any intervention.
0
16
0
16
2
16
Serious Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Lymphadenitis
Blood and lymphatic system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected88 at risk
EG0051 events1 affected86 at risk
EG0060 events0 affected86 at risk
EG0070 events0 affected79 at risk
EG0080 events0 affected78 at risk
EG0090 events0 affected1 at risk
EG0100 events0 affected24 at risk
EG0110 events0 affected16 at risk
Atrioventricular block complete
Cardiac disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Crohn's disease
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected83 at risk
EG003
Dyspepsia
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected83 at risk
EG003
Appendicitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Cellulitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Gastroenteritis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected83 at risk
EG003
Pneumonia haemophilus
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Tonsillitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Urinary tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Ankle fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0011 events1 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Avulsion fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Cervical vertebral fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Post procedural haematoma
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Radius fracture
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Road traffic accident
Injury, poisoning and procedural complications
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Blood creatine phosphokinase increased
Investigations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Arthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Osteoarthritis
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Plica syndrome
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Bladder cancer
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Parathyroid tumour benign
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Skin papilloma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Cerebral haemorrhage
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Subarachnoid haemorrhage
Nervous system disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Nephrolithiasis
Renal and urinary disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG003
Adnexal torsion
Reproductive system and breast disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Erythema multiforme
Skin and subcutaneous tissue disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0021 events1 affected83 at risk
EG003
Other Adverse Events
Term
Organ System
Source Vocabulary
Assessment Type
Notes
Statistical Information
Ocular discomfort
Eye disorders
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected86 at risk
EG0010 events0 affected90 at risk
EG0020 events0 affected83 at risk
EG0030 events0 affected81 at risk
EG0040 events0 affected88 at risk
EG0050 events0 affected86 at risk
EG0060 events0 affected86 at risk
EG0070 events0 affected79 at risk
EG0080 events0 affected78 at risk
EG0091 events1 affected1 at risk
EG0100 events0 affected24 at risk
EG0110 events0 affected16 at risk
Diarrhoea
Gastrointestinal disorders
MedDRA 21.1
Systematic Assessment
EG0002 events2 affected86 at risk
EG0014 events4 affected90 at risk
EG0022 events2 affected83 at risk
EG003
Injection site reaction
General disorders
MedDRA 21.1
Systematic Assessment
EG00033 events2 affected86 at risk
EG0016 events3 affected90 at risk
EG00237 events7 affected83 at risk
EG003
Nasopharyngitis
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0006 events6 affected86 at risk
EG0017 events6 affected90 at risk
EG0026 events5 affected83 at risk
EG003
Upper respiratory tract infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0005 events4 affected86 at risk
EG0013 events2 affected90 at risk
EG0024 events4 affected83 at risk
EG003
Vaginal infection
Infections and infestations
MedDRA 21.1
Systematic Assessment
EG0000 events0 affected15 at risk
EG0011 events1 affected17 at risk
EG0020 events0 affected19 at risk
EG003
Back pain
Musculoskeletal and connective tissue disorders
MedDRA 21.1
Systematic Assessment
EG0001 events1 affected86 at risk
EG0011 events1 affected90 at risk
EG0021 events1 affected83 at risk
EG003
Uterine leiomyoma
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG00040.2
OG00158.9
OG00264.2
OG00368.7
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
0.007
Odds Ratio (OR)
2.30
2-Sided
95
1.25
4.23
Superiority
OG000
OG002
Regression, Logistic
0.001
Odds Ratio (OR)
2.78
2-Sided
95
1.48
5.24
Superiority
OG000
OG003
Regression, Logistic
<0.001
Odds Ratio (OR)
3.39
2-Sided
95
1.79
6.41
Superiority
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-0.46± 0.099
OG001-1.30± 0.096
OG002-1.43± 0.102
OG003-1.37± 0.101
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
LSMean Difference
-0.84
Standard Error of the Mean
0.137
2-Sided
95
-1.11
-0.57
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-0.97
Standard Error of the Mean
0.141
2-Sided
95
-1.25
-0.70
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LSMean Difference
-0.91
Standard Error of the Mean
0.140
2-Sided
95
-1.18
-0.63
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG00017.2
OG00132.2
OG00242.0
OG00343.4
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.012
Odds Ratio (OR)
2.53
2-Sided
95
1.23
5.21
Superiority
OG000
OG002
Regression, Logistic
<0.001
Odds Ratio (OR)
3.74
2-Sided
95
1.82
7.70
Superiority
OG000
OG003
Regression, Logistic
<0.001
Odds Ratio (OR)
3.90
2-Sided
95
1.91
7.98
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-1.16± 0.215
OG001-2.14± 0.209
OG002-2.39± 0.222
OG003-2.43± 0.219
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
LSMean Difference
-0.97
Standard Error of the Mean
0.299
2-Sided
95
-1.56
-0.39
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-1.22
Standard Error of the Mean
0.307
2-Sided
95
-1.83
-0.62
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LSMean Difference
-1.27
Standard Error of the Mean
0.304
2-Sided
95
-1.86
-0.67
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG0002.3
OG00115.6
OG00216.0
OG00310.8
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Regression, Logistic
0.009
LSMean Difference
7.62
2-Sided
95
1.67
34.68
Superiority
OG000
OG002
Regression, Logistic
0.007
Odds Ratio (OR)
8.03
2-Sided
95
1.75
36.83
Superiority
OG000
OG003
Regression, Logistic
0.041
Odds Ratio (OR)
5.13
2-Sided
95
1.07
24.49
Superiority
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00081
OG00182
OG00278
OG00376
Title
Denominators
Categories
Title
Measurements
OG000-0.15± 0.323
OG001-2.92± 0.314
OG002-2.77± 0.328
OG003-2.54± 0.330
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
LSMean Difference
-2.78
Standard Error of the Mean
0.447
2-Sided
95
-3.7
-1.9
Superiority
OG000
OG002
ANCOVA
<0.001
LSMean Difference
-2.62
Standard Error of the Mean
0.450
2-Sided
95
-3.5
-1.7
Superiority
OG000
OG003
ANCOVA
<0.001
LSMean Difference
-2.39
Standard Error of the Mean
0.452
2-Sided
95
-3.3
-1.5
Superiority
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
PCS
Title
Measurements
OG0003.6432± 0.7530
OG0016.9005± 0.7310
OG0027.6952± 0.7768
OG0037.9686± 0.7665
MCS
Title
Measurements
OG0002.1229± 0.8431
OG0012.5550± 0.8225
OG0022.7502± 0.8763
OG003
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
PCS
Mixed Models Analysis
0.002
LSMean Difference
3.2574
Standard Error of the Mean
1.0437
2-Sided
95
1.2041
5.3106
Superiority
OG000
OG002
PCS
Mixed Models Analysis
<0.001
LSMean Difference
4.0520
Standard Error of the Mean
1.0720
2-Sided
95
1.9432
6.1608
Superiority
OG000
OG003
PCS
Mixed Models Analysis
<0.001
LSMean Difference
4.3254
Standard Error of the Mean
1.0641
2-Sided
95
2.2321
6.4186
Superiority
OG000
OG001
MCS
Mixed Models Analysis
0.713
LSMean Difference
0.4321
Standard Error of the Mean
1.1718
2-Sided
95
-1.8732
2.7373
Superiority
OG000
OG002
MCS
Mixed Models Analysis
0.602
LSMean Difference
0.6273
Standard Error of the Mean
1.2028
2-Sided
95
-1.7387
2.9934
Superiority
OG000
OG003
MCS
Mixed Models Analysis
0.709
LSMean Difference
0.4467
Standard Error of the Mean
1.1978
2-Sided
95
-1.9097
2.8030
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-1.25± 0.300
OG001-2.30± 0.292
OG002-2.36± 0.311
OG003-2.74± 0.306
Group IDs
Group Description
Statistical Method
Statistical Comment
P-Value
P-Value Comment
Parameter Type
Parameter Value
Dispersion Type
Dispersion Value
Confidence Interval Sides
Confidence Interval %
CI Lower Limit
CI Upper Limit
CI Lower Limit Comment
CI Upper Limit Comment
Estimate Comment
Tested Non-Inferiority
Non-Inferiority Type
Non-Inferiority Comment
Other Analysis Description
OG000
OG001
Mixed Models Analysis
0.012
LSMean Difference
-1.05
Standard Error of the Mean
0.416
2-Sided
95
-1.87
-0.23
Superiority
OG000
OG002
Mixed Models Analysis
0.010
LSMean Difference
-1.11
Standard Error of the Mean
0.428
2-Sided
95
-1.95
-0.27
Superiority
OG000
OG003
Mixed Models Analysis
<0.001
LSMean Difference
-1.49
Standard Error of the Mean
0.423
2-Sided
95
-2.32
-0.66
Superiority
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG0001.426± 1.9244
OG001-7.202± 1.8688
OG002-5.209± 1.9803
OG003-6.565± 1.9582
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
LSMean Difference
-8.628
Standard Error of the Mean
2.6724
2-Sided
95
-13.885
-3.371
Superiority
OG000
OG002
Mixed Models Analysis
0.016
LSMean Difference
-6.635
Standard Error of the Mean
2.7438
2-Sided
95
-12.033
-1.238
Superiority
OG000
OG003
Mixed Models Analysis
0.004
LSMean Difference
-7.991
Standard Error of the Mean
2.7248
2-Sided
95
-13.351
-2.631
Superiority
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-0.080± 0.0826
OG001-0.447± 0.0800
OG002-0.502± 0.0858
OG003-0.408± 0.0840
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
LSMean Difference
-0.367
Standard Error of the Mean
0.1143
2-Sided
95
-0.592
-0.142
Superiority
OG000
OG002
Mixed Models Analysis
<0.001
LSMean Difference
-0.422
Standard Error of the Mean
0.1184
2-Sided
95
-0.655
-0.189
Superiority
OG000
OG003
Mixed Models Analysis
0.005
LSMean Difference
-0.329
Standard Error of the Mean
0.1167
2-Sided
95
-0.558
-0.099
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG0000.06± 0.152
OG0010.70± 0.148
OG0020.49± 0.158
OG0030.67± 0.155
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
0.003
LSMean Difference
0.63
Standard Error of the Mean
0.211
2-Sided
95
0.22
1.05
Superiority
OG000
OG002
Mixed Models Analysis
0.051
LSMean Difference
0.43
Standard Error of the Mean
0.219
2-Sided
95
-0.00
0.86
Superiority
OG000
OG003
Mixed Models Analysis
0.005
LSMean Difference
0.60
Standard Error of the Mean
0.215
2-Sided
95
0.18
1.03
Superiority
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-0.06± 0.232
OG001-0.72± 0.225
OG002-0.69± 0.240
OG003-0.73± 0.236
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
0.039
LSMean Difference
-0.67
Standard Error of the Mean
0.321
2-Sided
95
-1.30
-0.03
Superiority
OG000
OG002
Mixed Models Analysis
0.057
LSMean Difference
-0.63
Standard Error of the Mean
0.330
2-Sided
95
-1.28
0.02
Superiority
OG000
OG003
Mixed Models Analysis
0.042
LSMean Difference
-0.67
Standard Error of the Mean
0.327
2-Sided
95
-1.31
-0.03
Superiority
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00081
OG00182
OG00278
OG00377
Title
Denominators
Categories
Title
Measurements
OG0000.92± 0.582
OG001-4.21± 0.568
OG002-3.97± 0.590
OG003-4.25± 0.591
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
LSMean Difference
-5.13
Standard Error of the Mean
0.806
2-Sided
95
-6.7
-3.5
Superiority
OG000
OG002
ANCOVA
<0.001
LSMean Difference
-4.89
Standard Error of the Mean
0.812
2-Sided
95
-6.5
-3.3
Superiority
OG000
OG003
ANCOVA
<0.001
LSMean Difference
-5.17
Standard Error of the Mean
0.816
2-Sided
95
-6.8
-3.6
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00056
OG00151
OG00249
OG00350
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.34
OG001-2.6± 0.34
OG002-2.3± 0.36
OG003-2.4± 0.35
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
0.317
LSMean Difference
-0.5
Standard Error of the Mean
0.48
2-Sided
95
-1.4
0.5
Superiority
OG000
OG002
Mixed Models Analysis
0.683
LSMean Difference
-0.2
Standard Error of the Mean
0.48
2-Sided
95
-1.1
0.8
Superiority
OG000
OG003
Mixed Models Analysis
0.500
LSMean Difference
-0.3
Standard Error of the Mean
0.48
2-Sided
95
-1.3
0.6
Superiority
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00041
OG00140
OG00240
OG00335
Title
Denominators
Categories
Title
Measurements
OG000-2.1± 0.40
OG001-2.9± 0.40
OG002-2.7± 0.40
OG003-2.6± 0.43
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
0.154
LSMean Difference
-0.8
Standard Error of the Mean
0.56
2-Sided
95
-1.9
0.3
Superiority
OG000
OG002
Mixed Models Analysis
-0.6
LSMean Difference
0.255
Standard Error of the Mean
0.56
2-Sided
95
-1.8
0.5
Superiority
OG000
OG003
Mixed Models Analysis
0.398
LSMean Difference
-0.5
Standard Error of the Mean
0.58
2-Sided
95
-1.6
0.7
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00051
OG00149
OG00244
OG00345
Title
Denominators
Categories
Title
Measurements
OG000-2.0± 0.53
OG001-2.2± 0.55
OG002-2.5± 0.58
OG003-3.3± 0.58
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
0.783
LSMean Difference
-0.2
Standard Error of the Mean
0.76
2-Sided
95
-1.7
1.3
Superiority
OG000
OG002
Mixed Models Analysis
0.550
LSMean Difference
-0.5
Standard Error of the Mean
0.78
2-Sided
95
-2.0
1.1
Superiority
OG000
OG003
Mixed Models Analysis
0.091
LSMean Difference
-1.3
Standard Error of the Mean
0.77
2-Sided
95
-2.8
0.2
Superiority
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG0000
OG0010
OG0021
OG0030
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-1.4± 0.23
OG001-2.2± 0.23
OG002-2.5± 0.24
OG003-2.1± 0.24
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
0.027
LSMean Difference
-0.7
Standard Error of the Mean
0.32
2-Sided
95
-1.3
-0.1
Superiority
OG000
OG001
Mixed Models Analysis
0.002
LSMean Difference
-1.0
Standard Error of the Mean
0.33
2-Sided
95
-1.7
-0.4
Superiority
OG000
OG003
Mixed Models Analysis
0.035
LSMean Difference
-0.7
Standard Error of the Mean
0.33
2-Sided
95
-1.3
-0.0
Superiority
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG000-1.5± 0.41
OG001-2.7± 0.40
OG002-2.5± 0.43
OG003-3.0± 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
0.041
LSMean Difference
-1.2
Standard Error of the Mean
0.57
2-Sided
95
-2.3
-0.0
Superiority
OG000
OG002
Mixed Models Analysis
0.125
LSMean Difference
-0.9
Standard Error of the Mean
0.59
2-Sided
95
-2.1
0.3
Superiority
OG000
OG003
Mixed Models Analysis
0.013
LSMean Difference
-1.4
Standard Error of the Mean
0.58
2-Sided
95
-2.6
-0.3
Superiority
IXE80Q4W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks by subcutaneous injection.
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Overall Work Impairment Score
Title
Measurements
OG000-17.82± 3.254
OG001-21.44± 2.921
OG002-21.36± 3.061
OG003-24.06± 3.299
Percentage of Activity Impairment
Title
Measurements
OG000-14.1± 2.28
OG001-21.1± 2.22
OG002-23.0± 2.35
OG003
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
0.989
LSMean Difference
0.04
Standard Error of the Mean
3.082
2-Sided
95
-6.03
6.12
Superiority
OG000
OG002
Mixed Models Analysis
0.429
LSMean Difference
2.50
Standard Error of the Mean
3.146
2-Sided
95
-3.71
8.70
Superiority
OG000
OG003
Mixed Models Analysis
0.096
LSMean Difference
-5.47
Standard Error of the Mean
3.270
2-Sided
95
-11.92
0.98
Superiority
OG003
Ixekizumab 80mg Q2W/Ixekizumab 80mg Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every four weeks during blinded treatment and extension period by subcutaneous injection.
Units
Counts
Participants
OG00078
OG00180
OG00271
OG00376
Title
Denominators
Categories
Title
Measurements
OG000-10.28± 27.472
OG001-5.91± 20.861
OG002-7.62± 25.430
OG003-9.91± 27.940
Units
Counts
Participants
OG00087
OG00190
OG00281
OG00383
Title
Denominators
Categories
Title
Measurements
OG0002
OG0015
OG0022
OG0032
Units
Counts
Participants
OG00042
OG00139
OG00245
OG00338
Title
Denominators
Categories
Title
Measurements
OG0003.56± 56
OG0013.88± 55
OG00211.6± 54
OG00311.3± 43
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.
Units
Counts
Participants
OG00022
OG00123
OG00224
OG00322
Title
Denominators
Categories
Title
Measurements
OG000-1.7± 0.55
OG001-2.7± 0.53
OG002-3.6± 0.53
OG003-2.7± 0.57
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
0.166
LSMean Difference
-1.1
Standard Error of the Mean
0.76
2-Sided
95
-2.6
0.4
Superiority
OG000
OG002
Mixed Models Analysis
0.011
LSMean Difference
-1.9
Standard Error of the Mean
0.73
2-Sided
95
-3.4
-0.4
Superiority
OG000
OG003
Mixed Models Analysis
0.182
LSMean Difference
-1.0
Standard Error of the Mean
0.77
2-Sided
95
-2.6
0.5
Superiority
OG003
IXE80Q2W
Participants received starting dose of either 80 milligrams (mg) or 160mg Ixekizumab at week 0 followed by 80mg Ixekizumab every two weeks by subcutaneous injection.