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COAST-X: A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Sponsor
Eli Lilly and Company (Industry)
Overall Status
Completed
CT.gov ID
NCT02757352
Collaborator
(none)
303
Enrollment
109
Locations
3
Arms
33.1
Actual Duration (Months)
2.8
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the safety and efficacy of the study drug known as ixekizumab in biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
303 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis
Actual Study Start Date :
Aug 2, 2016
Actual Primary Completion Date :
Mar 1, 2019
Actual Study Completion Date :
May 7, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Q2W Ixekizumab

Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52 during the double-blind period. Inadequate responders (IR) as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.

Drug: Ixekizumab
Administered SC
Other Names:
  • LY2439821

    		•
    Experimental: Q4W Ixekizumab

    Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52 during the double-blind period. Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label week 16 and 44.

    Drug: Ixekizumab
    Administered SC
    Other Names:
  • LY2439821

    		•
    Placebo Comparator: Placebo

    Participants received placebo as 2 SC injections Q2W to week 52 during double-blind period. Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44.

    Drug: Placebo
    Administered SC

    Outcome Measures

    Primary Outcome Measures

    1. Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response [Week 16]

      ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).

    2. Percentage of Participants Achieving an ASAS40 Response [Week 52]

      ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).

    Secondary Outcome Measures

    1. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [Baseline, Week 16]

      ASDAS is a composite index to assess disease activity in axial spondyloarthritis (axSpA). ASDAS parameters used with (C-reactive protein [CRP] as acute phase reactant) are: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling, duration of morning stiffness 4) CRP in mg/L: ASDAScrp is calculated with the equation: 0.121 × total back pain + 0.110×patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least squares mean (LS Mean) was derived from mixed models repeated measure analysis (MMRM) with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    2. Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [Baseline, Week 52]

      ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters used (with CRP as acute phase reactant) are: 1 )Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    3. Number of Participants Without Clinically Meaningful Changes in Background Therapy [Baseline through Week 52]

      Number of participants without changes in background therapy while on originally randomized treatment.

    4. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [Baseline, Week 16]

      The SF-36 is a 36-item patient-administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The Physical Component Summary score ranges from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    5. Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score [Baseline, Week 52]

      The medical outcomes study 36-item short-form health survey (SF-36) SF-36 PCS are summarized using the t-scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    6. Percentage of Participants Achieving ASDAS Low Disease Activity [Week 16]

      ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

    7. Percentage of Participants Achieving ASDAS Low Disease Activity [Week 52]

      ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

    8. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Baseline, Week 16]

      The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    9. Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [Baseline, Week 52]

      The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    10. Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score [Baseline, Week 16]

      Both left and right SIJ are scored for bone marrow edema. Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LS Mean was derived from ANCOVA model with treatment, geographic region, screening MRI/CRP status and baseline value as fixed factors.

    11. Change From Baseline in SPARCC Enthesitis Score [Baseline, Week 52]

      The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.

    12. Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [Baseline, Week 52]

      BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. Participants were asked to rate the difficulty associated with 10 individual basic functional activities. Participant responded to each question using a NRS scale (range 0 to 10), with a higher score indicating worse functioning. The participant's final BASFI score is the mean of the 10 item scores with the minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    13. Percentage of Participants Achieving ASDAS Inactive Disease [Week 52]

      ASDAS is a composite index to assess disease activity in axSpA. ASDAS Inactive Disease is defined as a score of less than (<)1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.

    14. Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) [Baseline, Week 52]

      High-sensitivity C-reactive protein (hs-CRP) was the measure of acute phase reactant and was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    15. Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [Baseline, Week 52]

      Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with axSpA: 1) Lateral spinal flexion 2) Tragus-to-wall distance 3) Lumbar flexion (modified Schrober) 4) Maximal intermalleolar distance, and 5) Cervical rotation. The BASMI includes these 5 measurements that were each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    16. Change From Baseline in Chest Expansion [Baseline, Week 52]

      While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    17. Change From Baseline in Occiput to Wall Distance [Baseline, Week 52]

      The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    18. Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [Baseline, Week 52]

      Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed included costochondral 1 (right/left [R/L]), costochondral 7 (R/L), spinal iliaca anterior superior (R/L), crista iliaca (R/L), spina iliaca posterior (R/L), processus spinosus L5, and achilles tendon proximal insertion (R/L). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    19. Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints [Baseline, Week 52]

      The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body). The 46 joints are assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). Swollen joint count SJC was determined by examination of 44 joints (22 joints on each side of the participants body). The joints are classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which is multiplied by 44 to obtain SJC score. Score ranges from 0 (not swollen) to 44 (all joints swollen). LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status and baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    20. Number of Participants With Anterior Uveitis [Baseline through Week 52]

      Number of participants with anterior uveitis. Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.

    21. Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score [Baseline, Week 52]

      The Fatigue Severity NRS is a participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    22. Change From Baseline in ASAS Health Index (ASAS HI) [Baseline, Week 52]

      ASAS-HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS Mean was derived MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    23. Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) [Baseline, Week 52]

      Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS Mean was derived from using MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.

    24. Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores [Baseline, Week 52]

      The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS Mean was derived from ANCOVA with treatment, geographic region, screening MRI/CRP status and baseline value.

    25. Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score [Baseline, Week 52]

      ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, the higher the score, the greater the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).

    26. Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies [Week 52]

      A treatment-emergent positive anti-drug antibody (TE-ADA+) participant will be defined as a 4-fold increase over a positive baseline antibody titer (Tier 3); or for a negative baseline titer, a participant with an increase from the baseline to a level of ≥ 1:10.

    27. Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) [Week 52]

      PK trough serum concentration samples were collected at steady state (Ctrough ss)

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Are ambulatory.

    • Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria.

    • Have a history of back pain ≥3 months with age at onset <45 years.

    • Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline.

    • Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP).

    • In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS.

    • If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization.

    • Have a history of prior therapy for axSpA for at least 12 weeks prior to screening.

    Exclusion Criteria:

    • Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria.

    • Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.

    • Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.

    • Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.

    • Have a compromised immune system.

    • Have any other serious and/or uncontrolled diseases.

    • Have either a current diagnosis or a recent history of malignant disease.

    • Have had major surgery within 8 weeks of baseline, or will require surgery during the study.

    • Are pregnant or breastfeeding.

    • Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Arizona Arthritis Research, PLC Phoenix Arizona United States 85032
    2 TriWest Research Assocaites El Cajon California United States 92020
    3 Rheumatology Center of San Diego Escondido California United States 92025
    4 Care Access Research - Huntington Beach Huntington Beach California United States 92648
    5 Desert Medical Advances Palm Desert California United States 92260
    6 Inlande Rheumatology Clinical Trials Upland California United States 91786
    7 Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC Colorado Springs Colorado United States 80920
    8 Clinical Research Center of CT/NY Danbury Connecticut United States 06810
    9 Sarasota Arthritis Center Sarasota Florida United States 34239
    10 West Broward Rheumatology Associates, Inc Tamarac Florida United States 33321
    11 Marietta Rheumatology Marietta Georgia United States 30060
    12 Institute of Arthritis Research Idaho Falls Idaho United States 83404
    13 The Arthritis & Diabetes Clinic Inc. Monroe Louisiana United States 71203
    14 Osteoporosis And Clinical Trial Center Cumberland Maryland United States 21502
    15 Osteoporosis And Clinical Trial Center Hagerstown Maryland United States 21740
    16 Glacier View Research Institute Kalispell Montana United States 59901
    17 Physician Research Collaboration, LLC Lincoln Nebraska United States 68516
    18 Weill Cornell Physicians at Brooklyn Heights Brooklyn New York United States 11201
    19 Shanahan Rheumatology & Immunotherapy Raleigh North Carolina United States 27617
    20 Carolina Arthritis Associates Wilmington North Carolina United States 28401
    21 Oregon Health and Science University Portland Oregon United States 97239
    22 Altoona Center for Clinical Research Duncansville Pennsylvania United States 16635
    23 Articularis Healthcare Group, INC dba Columbia Arthritis Ctr Columbia South Carolina United States 29204
    24 Seattle Rheumatology Associates, P.L.L.C. Seattle Washington United States 98122
    25 Arthritis Northwest Rheumatology Spokane Washington United States 99204
    26 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 Capital Federal Argentina C1430EGF
    27 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 Ciudad Autonoma de Buenos Aire Argentina C1428DZF
    28 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 Quilmes Argentina B1878DVC
    29 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician Rosario Argentina S2000CFJ
    30 For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Rosario Argentina S2000DEJ
    31 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 San Juan Argentina J5402DIL
    32 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 San Miguel de Tucuman Argentina T4000AXL
    33 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. San Miguel De Tucumán Argentina T4000BRD
    34 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 Wien Austria 1060
    35 "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." Wien Austria 1090
    36 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. Goiás Brazil 74043-110
    37 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 Juiz de Fora Brazil 36010-570
    38 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. Rio de Janeiro Brazil 21941-913
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    97 Office: Perez-De Jesus, Amarilis Caguas Puerto Rico 00725
    98 Ponce School of Medicine CAIMED Center Ponce Puerto Rico 00716
    99 Mindful Medical Research San Juan Puerto Rico 00918
    100 Latin Clinical Trial Center Santurce Puerto Rico 00909
    101 "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." Bucuresti Romania 011025
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    104 V.A. Nasonova Research Institute of Rheumatology Moscow Russian Federation 115522
    105 City Clinical Hospital #1 Moscow Russian Federation 119049
    106 Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary Ryazan Russian Federation 390026
    107 Saratov Regional Clinical Hospital Saratov Russian Federation 410053
    108 Clinical Rheumatology Hospital # 25 St. Petersburg Russian Federation 190068
    109 Clinical Hospital for Emergency Care Yaroslavl Russian Federation 150003

    Sponsors and Collaborators

    • Eli Lilly and Company

    Investigators

    • Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

    Study Documents (Full-Text)

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02757352
    Other Study ID Numbers:
    • 16180
    • I1F-MC-RHBX
    • 2015-003938-27
    First Posted:
    May 2, 2016
    Last Update Posted:
    Mar 13, 2020
    Last Verified:
    Aug 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Keywords provided by Eli Lilly and Company
    ankylosing
    nonradiographic spondyloarthritis
    Additional relevant MeSH terms:
    Spondylitis
    Spondylarthritis
    Ixekizumab

    Study Results

    Participant Flow

    Recruitment Details This study has 3 periods: Period 1 - Screening; Period 2 - A Double-Blind Treatment Period (Weeks 0 Up to 52); (Inadequate Responders [IR] Week 16-52) followed by a Follow-Up Period (Up to 24 Weeks after last visit)
    Pre-assignment Detail 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.
    Arm/Group Title Placebo Double-Blind Period Ixekizumab 80 mg Q4W (IxeQ4W) Double-Blind Period Ixekizumab 80 mg Q2W (IxeQ2W) Double-Blind Period PBO IR/Ixe80Q2W-Open Label Ixekizumab 80 mg Q4W IR (Ixe80Q4WIR)/Ixe80Q2W-Open Label Ixekizumab 80 mg Q2W IR (Ixe80Q2WIR)/Ixe80Q2W-Open Label Placebo Post Treatment Follow-Up Period Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period Other Biologic Treatment Group
    Arm/Group Description Participants received placebo (PBO) as 2 subcutaneous (SC) injections every two weeks (Q2W) to week 52. Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC (Q2W) to week 52. Participants who received placebo in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label. Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label. Participants who received ixekizumab 80 mg Q2W in double blind period and were inadequate responders as determined by investigators continued on the same regimen of ixekizumab 80 mg Q2W open label. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period Participants who discontinued study treatment and were on other biologic therapy prior to entering follow-up period.
    Period Title: Double-Blind Period (Week 0 - Week 16)
    STARTED 105 96 102 0 0 0 0 0 0 0
    Received at Least One Dose of Study Drug 104 96 102 0 0 0 0 0 0 0
    COMPLETED 97 95 98 0 0 0 0 0 0 0
    NOT COMPLETED 8 1 4 0 0 0 0 0 0 0
    Period Title: Double-Blind Period (Week 0 - Week 16)
    STARTED 97 95 98 0 0 0 0 0 0 0
    COMPLETED 34 52 52 0 0 0 0 0 0 0
    NOT COMPLETED 63 43 46 0 0 0 0 0 0 0
    Period Title: Double-Blind Period (Week 0 - Week 16)
    STARTED 0 0 0 62 40 42 0 0 0 0
    Initiated Other Biologic Rescue 0 0 0 2 0 3 0 0 0 0
    COMPLETED 0 0 0 55 37 35 0 0 0 0
    NOT COMPLETED 0 0 0 7 3 7 0 0 0 0
    Period Title: Double-Blind Period (Week 0 - Week 16)
    STARTED 0 0 0 0 0 0 3 5 28 5
    COMPLETED 0 0 0 0 0 0 2 4 18 2
    NOT COMPLETED 0 0 0 0 0 0 1 1 10 3

    Baseline Characteristics

    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W Total
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52. Total of all reporting groups
    Overall Participants 105 96 102 303
    Age (years) [Mean (Standard Deviation) ]
    Mean (Standard Deviation) [years]
    39.9
    (12.36)
    40.9
    (14.47)
    40.0
    (12.01)
    40.3
    (12.92)
    Sex: Female, Male (Count of Participants)
    Female
    61
    58.1%
    46
    47.9%
    53
    52%
    160
    52.8%
    Male
    44
    41.9%
    50
    52.1%
    49
    48%
    143
    47.2%
    Ethnicity (NIH/OMB) (Count of Participants)
    Hispanic or Latino
    25
    23.8%
    24
    25%
    31
    30.4%
    80
    26.4%
    Not Hispanic or Latino
    68
    64.8%
    57
    59.4%
    63
    61.8%
    188
    62%
    Unknown or Not Reported
    12
    11.4%
    15
    15.6%
    8
    7.8%
    35
    11.6%
    Race (NIH/OMB) (Count of Participants)
    American Indian or Alaska Native
    8
    7.6%
    2
    2.1%
    3
    2.9%
    13
    4.3%
    Asian
    17
    16.2%
    13
    13.5%
    11
    10.8%
    41
    13.5%
    Native Hawaiian or Other Pacific Islander
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    Black or African American
    0
    0%
    0
    0%
    0
    0%
    0
    0%
    White
    76
    72.4%
    80
    83.3%
    83
    81.4%
    239
    78.9%
    More than one race
    3
    2.9%
    1
    1%
    5
    4.9%
    9
    3%
    Unknown or Not Reported
    1
    1%
    0
    0%
    0
    0%
    1
    0.3%
    Region of Enrollment (Count of Participants)
    Argentina
    8
    7.6%
    6
    6.3%
    9
    8.8%
    23
    7.6%
    Romania
    5
    4.8%
    1
    1%
    4
    3.9%
    10
    3.3%
    United States
    10
    9.5%
    9
    9.4%
    9
    8.8%
    28
    9.2%
    Czechia
    15
    14.3%
    16
    16.7%
    13
    12.7%
    44
    14.5%
    Japan
    6
    5.7%
    5
    5.2%
    5
    4.9%
    16
    5.3%
    Russia
    12
    11.4%
    7
    7.3%
    8
    7.8%
    27
    8.9%
    Canada
    1
    1%
    3
    3.1%
    2
    2%
    6
    2%
    Austria
    0
    0%
    1
    1%
    2
    2%
    3
    1%
    South Korea
    9
    8.6%
    7
    7.3%
    6
    5.9%
    22
    7.3%
    Netherlands
    0
    0%
    0
    0%
    1
    1%
    1
    0.3%
    Finland
    4
    3.8%
    3
    3.1%
    3
    2.9%
    10
    3.3%
    Brazil
    0
    0%
    1
    1%
    2
    2%
    3
    1%
    Poland
    19
    18.1%
    18
    18.8%
    20
    19.6%
    57
    18.8%
    Mexico
    14
    13.3%
    13
    13.5%
    15
    14.7%
    42
    13.9%
    Germany
    2
    1.9%
    6
    6.3%
    3
    2.9%
    11
    3.6%

    Outcome Measures

    1. Primary Outcome
    Title Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
    Description ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the nonresponder imputation (NRI) method.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Number [percentage of participants]
    19.0
    18.1%
    35.4
    36.9%
    40.2
    39.4%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.36
    Confidence Interval (2-Sided) 95%
    1.23 to 4.51
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.78
    Confidence Interval (2-Sided) 95%
    1.48 to 5.25
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    2. Primary Outcome
    Title Percentage of Participants Achieving an ASAS40 Response
    Description ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the nonresponder imputation (NRI) method.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Number [percentage of participants]
    13.3
    12.7%
    30.2
    31.5%
    31.4
    30.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.82
    Confidence Interval (2-Sided) 95%
    1.38 to 5.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.85
    Confidence Interval (2-Sided) 95%
    1.40 to 5.77
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    3. Secondary Outcome
    Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
    Description ASDAS is a composite index to assess disease activity in axial spondyloarthritis (axSpA). ASDAS parameters used with (C-reactive protein [CRP] as acute phase reactant) are: 1) Total back pain 2) Patient global 3) Peripheral pain/swelling, duration of morning stiffness 4) CRP in mg/L: ASDAScrp is calculated with the equation: 0.121 × total back pain + 0.110×patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. Least squares mean (LS Mean) was derived from mixed models repeated measure analysis (MMRM) with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -0.58
    (0.095)
    -1.12
    (0.097)
    -1.26
    (0.095)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.54
    Confidence Interval (2-Sided) 95%
    -0.81 to -0.28
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.136
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.68
    Confidence Interval (2-Sided) 95%
    -0.94 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.134
    Estimation Comments
    4. Secondary Outcome
    Title Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
    Description ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters used (with CRP as acute phase reactant) are: 1 )Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -0.78
    (0.136)
    -1.39
    (0.116)
    -1.47
    (0.116)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.61
    Confidence Interval (2-Sided) 95%
    -0.96 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.179
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.69
    Confidence Interval (2-Sided) 95%
    -1.05 to -0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.178
    Estimation Comments
    5. Secondary Outcome
    Title Number of Participants Without Clinically Meaningful Changes in Background Therapy
    Description Number of participants without changes in background therapy while on originally randomized treatment.
    Time Frame Baseline through Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. Additional analysis not performed due to small number of participants with changes in background therapy and complete overlap with switch to open-label ixekizumab.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Count of Participants [Participants]
    98
    93.3%
    90
    93.8%
    100
    98%
    6. Secondary Outcome
    Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
    Description The SF-36 is a 36-item patient-administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The Physical Component Summary score ranges from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52.. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    5.2103
    (0.7999)
    8.0612
    (0.8129)
    7.9600
    (0.8023)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.8509
    Confidence Interval (2-Sided) 95%
    0.6092 to 5.0926
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.1390
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.015
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 2.7497
    Confidence Interval (2-Sided) 95%
    0.5299 to 4.9694
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.1278
    Estimation Comments
    7. Secondary Outcome
    Title Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
    Description The medical outcomes study 36-item short-form health survey (SF-36) SF-36 PCS are summarized using the t-scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    4.7210
    (1.2459)
    8.9211
    (1.0783)
    9.3291
    (1.0810)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.012
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.2001
    Confidence Interval (2-Sided) 95%
    0.9525 to 7.4477
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6467
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 4.6081
    Confidence Interval (2-Sided) 95%
    1.3629 to 7.8533
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.6455
    Estimation Comments
    8. Secondary Outcome
    Title Percentage of Participants Achieving ASDAS Low Disease Activity
    Description ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
    Time Frame Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline ASDAS <2.1. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 94 102
    Number [percentage of participants]
    12.4
    11.8%
    27.7
    28.9%
    32.4
    31.8%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 2.73
    Confidence Interval (2-Sided) 95%
    1.30 to 5.76
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.43
    Confidence Interval (2-Sided) 95%
    1.66 to 7.08
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    9. Secondary Outcome
    Title Percentage of Participants Achieving ASDAS Low Disease Activity
    Description ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline ASDAS <2.1. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 94 102
    Number [percentage of participants]
    8.6
    8.2%
    29.8
    31%
    27.5
    27%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.58
    Confidence Interval (2-Sided) 95%
    2.02 to 10.41
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 3.99
    Confidence Interval (2-Sided) 95%
    1.76 to 9.05
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    10. Secondary Outcome
    Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    Description The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -1.51
    (0.216)
    -2.18
    (0.220)
    -2.52
    (0.217)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.031
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Means Square Difference
    Estimated Value -0.67
    Confidence Interval (2-Sided) 95%
    -1.28 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.308
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.001
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.01
    Confidence Interval (2-Sided) 95%
    -1.61 to -0.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.305
    Estimation Comments
    11. Secondary Outcome
    Title Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
    Description The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -1.76
    (0.305)
    -2.89
    (0.266)
    -3.04
    (0.266)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.13
    Confidence Interval (2-Sided) 95%
    -1.92 to -0.33
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.404
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.002
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.29
    Confidence Interval (2-Sided) 95%
    -2.08 to -0.49
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.404
    Estimation Comments
    12. Secondary Outcome
    Title Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
    Description Both left and right SIJ are scored for bone marrow edema. Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LS Mean was derived from ANCOVA model with treatment, geographic region, screening MRI/CRP status and baseline value as fixed factors.
    Time Frame Baseline, Week 16

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline and Week 16 SPARCC score. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 90 85 92
    Least Squares Mean (Standard Error) [score on a scale]
    -0.31
    (0.539)
    -3.38
    (0.549)
    -4.52
    (0.530)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.07
    Confidence Interval (2-Sided) 95%
    -4.58 to -1.57
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.764
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value <0.001
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -4.20
    Confidence Interval (2-Sided) 95%
    -5.68 to -2.72
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.751
    Estimation Comments
    13. Secondary Outcome
    Title Change From Baseline in SPARCC Enthesitis Score
    Description The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with a baseline SPARCC score >0. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 86 65 74
    Least Squares Mean (Standard Error) [score on a scale]
    -2.87
    (0.447)
    -2.99
    (0.427)
    -3.14
    (0.407)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.849
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.12
    Confidence Interval (2-Sided) 95%
    -1.35 to 1.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.621
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.648
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.28
    Confidence Interval (2-Sided) 95%
    -1.48 to 0.93
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.608
    Estimation Comments
    14. Secondary Outcome
    Title Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
    Description BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. Participants were asked to rate the difficulty associated with 10 individual basic functional activities. Participant responded to each question using a NRS scale (range 0 to 10), with a higher score indicating worse functioning. The participant's final BASFI score is the mean of the 10 item scores with the minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -1.57
    (0.333)
    -2.63
    (0.292)
    -2.75
    (0.291)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.018
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.06
    Confidence Interval (2-Sided) 95%
    -1.93 to -0.18
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.443
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.18
    Confidence Interval (2-Sided) 95%
    -2.05 to -0.31
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.442
    Estimation Comments
    15. Secondary Outcome
    Title Percentage of Participants Achieving ASDAS Inactive Disease
    Description ASDAS is a composite index to assess disease activity in axSpA. ASDAS Inactive Disease is defined as a score of less than (<)1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data was imputed using the NRI method.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Number [percentage of participants]
    2.9
    2.8%
    13.5
    14.1%
    10.8
    10.6%
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.0011
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 5.33
    Confidence Interval (2-Sided) 96%
    1.47 to 19.40
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.031
    Comments
    Method Regression, Logistic
    Comments
    Method of Estimation Estimation Parameter Odds Ratio (OR)
    Estimated Value 4.22
    Confidence Interval (2-Sided) 95%
    1.14 to 15.66
    Parameter Dispersion Type:
    Value:
    Estimation Comments
    16. Secondary Outcome
    Title Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
    Description High-sensitivity C-reactive protein (hs-CRP) was the measure of acute phase reactant and was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [milligram/liter (mg/L)]
    -4.804
    (2.0370)
    -8.611
    (2.0028)
    -7.547
    (1.9654)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.183
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.807
    Confidence Interval (2-Sided) 95%
    -9.418 to 1.804
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.8507
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.331
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -2.743
    Confidence Interval (2-Sided) 95%
    -8.294 to 2.807
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 2.8202
    Estimation Comments
    17. Secondary Outcome
    Title Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
    Description Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with axSpA: 1) Lateral spinal flexion 2) Tragus-to-wall distance 3) Lumbar flexion (modified Schrober) 4) Maximal intermalleolar distance, and 5) Cervical rotation. The BASMI includes these 5 measurements that were each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -0.17
    (0.112)
    -0.56
    (0.097)
    -0.48
    (0.097)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.008
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.40
    Confidence Interval (2-Sided) 95%
    -0.69 to -0.10
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.148
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.038
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.31
    Confidence Interval (2-Sided) 95%
    -0.60 to -0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.148
    Estimation Comments
    18. Secondary Outcome
    Title Change From Baseline in Chest Expansion
    Description While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [centimeter (cm)]
    0.57
    (0.253)
    0.62
    (0.206)
    0.91
    (0.209)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.871
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.05
    Confidence Interval (2-Sided) 95%
    -0.59 to 0.70
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.325
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.295
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value 0.34
    Confidence Interval (2-Sided) 95%
    -0.30 to 0.99
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.327
    Estimation Comments
    19. Secondary Outcome
    Title Change From Baseline in Occiput to Wall Distance
    Description The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [cm]
    0.04
    (0.312)
    -0.42
    (0.257)
    -0.73
    (0.259)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.257
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.46
    Confidence Interval (2-Sided) 95%
    -1.26 to 0.34
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.406
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.057
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.77
    Confidence Interval (2-Sided) 95%
    -1.56 to 0.02
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.402
    Estimation Comments
    20. Secondary Outcome
    Title Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
    Description Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed included costochondral 1 (right/left [R/L]), costochondral 7 (R/L), spinal iliaca anterior superior (R/L), crista iliaca (R/L), spina iliaca posterior (R/L), processus spinosus L5, and achilles tendon proximal insertion (R/L). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline Mases score > 0. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -2.34
    (0.361)
    -3.21
    (0.342)
    -3.19
    (0.336)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.082
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.87
    Confidence Interval (2-Sided) 95%
    -1.85 to 0.11
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.496
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.088
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.85
    Confidence Interval (2-Sided) 95%
    -1.82 to 0.13
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.493
    Estimation Comments
    21. Secondary Outcome
    Title Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints
    Description The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body). The 46 joints are assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). Swollen joint count SJC was determined by examination of 44 joints (22 joints on each side of the participants body). The joints are classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which is multiplied by 44 to obtain SJC score. Score ranges from 0 (not swollen) to 44 (all joints swollen). LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status and baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants with baseline TJC>0 for the TJC analysis. All randomized participants with baseline SJC>0 for the SJC analysis. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    TJC
    -0.59
    (1.039)
    -2.38
    (0.993)
    -4.12
    (0.916)
    SJC
    -3.66
    (0.261)
    -4.63
    (0.237)
    -4.41
    (0.228)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments TJC
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.219
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -1.79
    Confidence Interval (2-Sided) 95%
    -4.66 to 1.09
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.442
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments TJC
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.013
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -3.53
    Confidence Interval (2-Sided) 95%
    -6.30 to -0.76
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 1.388
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments SJC
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.009
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -1.68 to -0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.355
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments SJC
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.034
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.76
    Confidence Interval (2-Sided) 95%
    -1.46 to -0.06
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.348
    Estimation Comments
    22. Secondary Outcome
    Title Number of Participants With Anterior Uveitis
    Description Number of participants with anterior uveitis. Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
    Time Frame Baseline through Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants regardless of history of anterior uveitis. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Count of Participants [Participants]
    2
    1.9%
    1
    1%
    2
    2%
    23. Secondary Outcome
    Title Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
    Description The Fatigue Severity NRS is a participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -2.1
    (0.38)
    -2.6
    (0.32)
    -2.7
    (0.32)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.325
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.5
    Confidence Interval (2-Sided) 95%
    -1.5 to 0.5
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.206
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.6
    Confidence Interval (2-Sided) 95%
    -1.6 to 0.4
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.50
    Estimation Comments
    24. Secondary Outcome
    Title Change From Baseline in ASAS Health Index (ASAS HI)
    Description ASAS-HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS Mean was derived MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [score on a scale]
    -2.57
    (0.455)
    -3.16
    (0.395)
    -3.54
    (0.396)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.330
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.59
    Confidence Interval (2-Sided) 95%
    -1.77 to 0.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.601
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.110
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.97
    Confidence Interval (2-Sided) 95%
    -2.15 to 0.22
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.602
    Estimation Comments
    25. Secondary Outcome
    Title Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
    Description Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS Mean was derived from using MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Least Squares Mean (Standard Error) [units on a scale]
    -2.9
    (0.63)
    -3.6
    (0.52)
    -3.6
    (0.53)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.348
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.8
    Confidence Interval (2-Sided) 95%
    -2.4 to 0.8
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.81
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.386
    Comments
    Method Mixed Models Analysis
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -0.7
    Confidence Interval (2-Sided) 95%
    -2.3 to 0.9
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 0.82
    Estimation Comments
    26. Secondary Outcome
    Title Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
    Description The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS Mean was derived from ANCOVA with treatment, geographic region, screening MRI/CRP status and baseline value.
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included. Missing data were imputed using the modified baseline observation carried forward (mBOCF).
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 105 96 102
    Overall Impairment Score
    -13.20
    (3.386)
    -26.96
    (3.439)
    -19.49
    (3.221)
    Percentage of absenteeism
    -3.11
    (2.215)
    -9.01
    (2.257)
    -7.26
    (2.151)
    Percentage of presenteeism
    -12.40
    (3.200)
    -26.01
    (3.245)
    -18.61
    (3.047)
    Percentage of impairment in activities
    -14.42
    (2.584)
    -25.05
    (2.617)
    -24.41
    (2.567)
    Statistical Analysis 1
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments Overall Impairment Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.005
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -13.76
    Confidence Interval (2-Sided) 95%
    -23.32 to -4.20
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.835
    Estimation Comments
    Statistical Analysis 2
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments Overall Impairment Score
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.183
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -6.29
    Confidence Interval (2-Sided) 95%
    -15.58 to 3.00
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.697
    Estimation Comments
    Statistical Analysis 3
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments Percentage of absenteeism
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.060
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -5.90
    Confidence Interval (2-Sided) 95%
    -12.05 to 0.26
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.114
    Estimation Comments
    Statistical Analysis 4
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments Percentage of absenteeism
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.182
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -4.15
    Confidence Interval (2-Sided) 95%
    -10.27 to 1.97
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.098
    Estimation Comments
    Statistical Analysis 5
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments Percentage of presentism
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.003
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -13.61
    Confidence Interval (2-Sided) 95%
    -22.62 to -4.60
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.558
    Estimation Comments
    Statistical Analysis 6
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments Percentage of presentism
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.164
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -6.21
    Confidence Interval (2-Sided) 95%
    -15.00 to 2.58
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 4.446
    Estimation Comments
    Statistical Analysis 7
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q4W
    Comments Percentage of Impairment in Activities Performed Outside of Work
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.004
    Comments
    Method LS Mean Difference
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -10.63
    Confidence Interval (2-Sided) 95%
    -17.85 to -3.41
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.669
    Estimation Comments
    Statistical Analysis 8
    Statistical Analysis Overview Comparison Group Selection Placebo, Ixekizumab 80 mg Q2W
    Comments Percentage of Impairment in Activities Performed Outside of Work
    Type of Statistical Test Superiority
    Comments
    Statistical Test of Hypothesis p-Value 0.006
    Comments
    Method ANCOVA
    Comments
    Method of Estimation Estimation Parameter LS Mean Difference
    Estimated Value -9.99
    Confidence Interval (2-Sided) 95%
    -17.12 to -2.86
    Parameter Dispersion Type: Standard Error of the Mean
    Value: 3.621
    Estimation Comments
    27. Secondary Outcome
    Title Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
    Description ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, & the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, the higher the score, the greater the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
    Time Frame Baseline, Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had NSAID (including COX-2 Inhibitor) intake at Baseline. For inadequate responders who were treated with open label ixekizumab 80 mg Q2W, only data up to the time of initiation of open label of ixekizumab 80 mg Q2W were included.
    Arm/Group Title Placebo Ixekizumab 80 mg Q4W Ixekizumab 80 mg Q2W
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 and placebo followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52.
    Measure Participants 96 81 95
    Mean (Standard Deviation) [score on a scale]
    -8.89
    (29.986)
    -7.91
    (34.257)
    -5.33
    (20.935)
    28. Secondary Outcome
    Title Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies
    Description A treatment-emergent positive anti-drug antibody (TE-ADA+) participant will be defined as a 4-fold increase over a positive baseline antibody titer (Tier 3); or for a negative baseline titer, a participant with an increase from the baseline to a level of ≥ 1:10.
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participant who received at least one dose of ixekizumab during the study and had an evaluable baseline sample and at least 1 evaluable post baseline sample.
    Arm/Group Title Ixe80Q2W-Q2W Ixe80Q4W-Q4W PBO-Ixe80Q2W Ixe80Q4W-Q2W
    Arm/Group Description Participants received a starting dose of 80 ixekizumab as an SC injection at week 0 followed by 80 mg of ixe every two weeks (Q2W) week 2 to week 52. Participants received a starting dose of 80 ixekizumab as an SC injection followed by 80 mg of ixekizumab Q4W week 4 to week 52. Participants who received placebo in double blind period and were inadequate responders switched to ixekizumab 80 mg Q2W open-label. Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders switched to ixekizumab 80 mg Q2W open label.
    Measure Participants 102 56 62 40
    Count of Participants [Participants]
    14
    13.3%
    5
    5.2%
    8
    7.8%
    2
    0.7%
    29. Secondary Outcome
    Title Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
    Description PK trough serum concentration samples were collected at steady state (Ctrough ss)
    Time Frame Week 52

    Outcome Measure Data

    Analysis Population Description
    All randomized participants who had evaluable PK data.
    Arm/Group Title IxeQ2W (80S)/IxeQ2W IxeQ2W (80S)/IxeQ2W Open Label IxeQ2W (160S)/IxeQ2W IxeQ2W (160s)/IxeQ2W Open Label IxeQ4W (80S) IxeQ4W IxeQ4W (80S)/IxeQ2W Open Label IxeQ4W(160S)/IxeQ4W IxeQ4W (160S) IxeQ2W Open Label PBO/IxeQ2W Open Label
    Arm/Group Description Ixekizumab was administered subcutaneously every 2 weeks with an 80 mg starting dose at week 0. Ixekizumab was administered every 2 weeks with an 80 mg starting dose at Week 0, then ixekizumab 80 mg Q2W open label between Week 16 and Week 52. Ixekizumab was administered subcutaneously every 2 weeks with an 160 mg starting dose at week 0. Ixekizumab was administered subcutaneously every 2 weeks with an 160 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52. Ixekizumab was administered subcutaneously every 4 weeks with an 80 mg starting dose at week 0. Ixekizumab was administered subcutaneously every 4 weeks with an 80 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52. Ixekizumab was administered subcutaneously every 4 weeks with an 160 mg starting dose at week 0. Ixekizumab was administered subcutaneously every 4 weeks with an 160 mg starting dose at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52. Placebo was administered at week 0 then ixekizumab 80 mg Q2W open label between Week 16 and Week 52.
    Measure Participants 32 18 28 24 28 19 28 21 55
    Geometric Mean (Geometric Coefficient of Variation) [microgram/milliliter (μg/mL)]
    7.88
    (73)
    9.56
    (60)
    10.3
    (61)
    10.4
    (72)
    2.88
    (49)
    6.45
    (124)
    3.54
    (79)
    11.5
    (53)
    9.25
    (66)

    Adverse Events

    Time Frame Up to 76 Weeks
    Adverse Event Reporting Description All randomized participants who received at least one dose of study drug during the study. Gender specific events only occurring in male or female participants have had the number of participants at risk adjusted accordingly.
    Arm/Group Title Placebo Double-Blind Period Ixekizumab 80 mg Q4W Double-Blind Period Ixekizumab 80 mg Q2W Double-Blind Period PBO IR/IxeQ2W Open Label Ixe80Q4WIR/Ixe80Q2W Open Label Ixe80Q2WIR/Ixe80Q2W Open Label Other Biologic Open Label Placebo Post Treatment Follow-Up Period Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period Other Biologic Post Treatment Follow-Up Period
    Arm/Group Description Participants received placebo as 2 SC injections Q2W to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52. Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52. Participants who received placebo in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label. Participants who received ixekizumab 80 mg Q4W in double blind period and were inadequate responders as determined by investigators switched to ixekizumab 80 mg Q2W open label. Participants who received ixekizumab 80 mg Q2W in double blind period and were inadequate responders as determined by investigators continued on the same regimen of ixekizumab 80 mg Q2W open label. Participants who discontinued study treatment and were on other biologic therapy prior to entering Follow-up period Participants discontinued the study early and entered the post-treatment follow-up period. Participants received placebo immediately prior to entering the post-treatment follow-up period. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q4W immediately prior to entering the post-treatment follow-up period. Participants discontinued the study early and entered the post-treatment follow-up period. Participants received ixekizumab 80 mg Q2W immediately prior to entering the post-treatment follow-up period. Participants who discontinued study treatment and were on other biologic therapy prior to entering follow-up period.
    All Cause Mortality
    Placebo Double-Blind Period Ixekizumab 80 mg Q4W Double-Blind Period Ixekizumab 80 mg Q2W Double-Blind Period PBO IR/IxeQ2W Open Label Ixe80Q4WIR/Ixe80Q2W Open Label Ixe80Q2WIR/Ixe80Q2W Open Label Other Biologic Open Label Placebo Post Treatment Follow-Up Period Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period Other Biologic Post Treatment Follow-Up Period
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 0/104 (0%) 0/96 (0%) 0/102 (0%) 0/42 (0%) 0/40 (0%) 0/62 (0%) 0/5 (0%) 0/3 (0%) 0/5 (0%) 0/28 (0%) 0/5 (0%)
    Serious Adverse Events
    Placebo Double-Blind Period Ixekizumab 80 mg Q4W Double-Blind Period Ixekizumab 80 mg Q2W Double-Blind Period PBO IR/IxeQ2W Open Label Ixe80Q4WIR/Ixe80Q2W Open Label Ixe80Q2WIR/Ixe80Q2W Open Label Other Biologic Open Label Placebo Post Treatment Follow-Up Period Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period Other Biologic Post Treatment Follow-Up Period
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 1/104 (1%) 2/96 (2.1%) 1/102 (1%) 1/42 (2.4%) 0/40 (0%) 2/62 (3.2%) 0/5 (0%) 0/3 (0%) 0/5 (0%) 1/28 (3.6%) 0/5 (0%)
    Gastrointestinal disorders
    Abdominal pain 0/104 (0%) 0 1/96 (1%) 1 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Immune system disorders
    Anaphylactoid reaction 1/104 (1%) 1 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Infections and infestations
    Erysipelas 0/104 (0%) 0 1/96 (1%) 2 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Sinusitis 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 1/62 (1.6%) 1 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Musculoskeletal and connective tissue disorders
    Axial spondyloarthritis 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/28 (3.6%) 1 0/5 (0%) 0
    Intervertebral disc protrusion 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 1/62 (1.6%) 1 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Osteoarthritis 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 1/62 (1.6%) 1 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Nervous system disorders
    Focal dyscognitive seizures 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 1/28 (3.6%) 1 0/5 (0%) 0
    Psychiatric disorders
    Major depression 0/104 (0%) 0 0/96 (0%) 0 1/102 (1%) 2 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Somatic symptom disorder 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 1/42 (2.4%) 1 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Other (Not Including Serious) Adverse Events
    Placebo Double-Blind Period Ixekizumab 80 mg Q4W Double-Blind Period Ixekizumab 80 mg Q2W Double-Blind Period PBO IR/IxeQ2W Open Label Ixe80Q4WIR/Ixe80Q2W Open Label Ixe80Q2WIR/Ixe80Q2W Open Label Other Biologic Open Label Placebo Post Treatment Follow-Up Period Ixekizumab 80 mg Q4W Post Treatment Follow-Up Period Ixekizumab 80 mg Q2W Post Treatment Follow-Up Period Other Biologic Post Treatment Follow-Up Period
    Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
    Total 31/104 (29.8%) 43/96 (44.8%) 47/102 (46.1%) 13/42 (31%) 15/40 (37.5%) 26/62 (41.9%) 3/5 (60%) 1/3 (33.3%) 1/5 (20%) 1/28 (3.6%) 0/5 (0%)
    Eye disorders
    Iritis 0/104 (0%) 0 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 1/5 (20%) 1 0/28 (0%) 0 0/5 (0%) 0
    Gastrointestinal disorders
    Abdominal pain upper 1/104 (1%) 1 1/96 (1%) 1 1/102 (1%) 1 0/42 (0%) 0 3/40 (7.5%) 3 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Nausea 1/104 (1%) 1 1/96 (1%) 1 1/102 (1%) 1 4/42 (9.5%) 4 2/40 (5%) 2 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    General disorders
    Influenza like illness 2/104 (1.9%) 4 0/96 (0%) 0 0/102 (0%) 0 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 0/5 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Injection site erythema 1/104 (1%) 3 3/96 (3.1%) 7 4/102 (3.9%) 11 2/42 (4.8%) 5 0/40 (0%) 0 5/62 (8.1%) 6 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Injection site reaction 4/104 (3.8%) 7 11/96 (11.5%) 24 17/102 (16.7%) 56 3/42 (7.1%) 11 3/40 (7.5%) 28 11/62 (17.7%) 63 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Infections and infestations
    Bacterial vaginosis 0/61 (0%) 0 1/46 (2.2%) 1 0/53 (0%) 0 0/28 (0%) 0 1/15 (6.7%) 1 2/41 (4.9%) 2 0/4 (0%) 0 0/1 (0%) 0 0/3 (0%) 0 0/19 (0%) 0 0/4 (0%) 0
    Bronchitis 3/104 (2.9%) 4 7/96 (7.3%) 7 2/102 (2%) 2 1/42 (2.4%) 1 1/40 (2.5%) 1 5/62 (8.1%) 5 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Nasopharyngitis 8/104 (7.7%) 11 18/96 (18.8%) 26 16/102 (15.7%) 27 2/42 (4.8%) 3 7/40 (17.5%) 10 6/62 (9.7%) 8 1/5 (20%) 1 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Pharyngitis 4/104 (3.8%) 4 4/96 (4.2%) 5 2/102 (2%) 2 2/42 (4.8%) 2 3/40 (7.5%) 3 3/62 (4.8%) 3 0/5 (0%) 0 1/3 (33.3%) 1 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Sinusitis 1/104 (1%) 1 2/96 (2.1%) 2 2/102 (2%) 2 3/42 (7.1%) 3 1/40 (2.5%) 1 1/62 (1.6%) 1 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Upper respiratory tract infection 4/104 (3.8%) 4 4/96 (4.2%) 4 6/102 (5.9%) 7 2/42 (4.8%) 2 3/40 (7.5%) 4 4/62 (6.5%) 5 1/5 (20%) 1 0/3 (0%) 0 0/5 (0%) 0 1/28 (3.6%) 1 0/5 (0%) 0
    Vulvovaginal mycotic infection 0/61 (0%) 0 1/46 (2.2%) 1 0/53 (0%) 0 0/28 (0%) 0 1/15 (6.7%) 1 0/41 (0%) 0 0/4 (0%) 0 0/1 (0%) 0 0/3 (0%) 0 0/19 (0%) 0 0/4 (0%) 0
    Musculoskeletal and connective tissue disorders
    Back pain 2/104 (1.9%) 2 3/96 (3.1%) 3 2/102 (2%) 2 0/42 (0%) 0 0/40 (0%) 0 0/62 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Nervous system disorders
    Headache 4/104 (3.8%) 4 7/96 (7.3%) 7 5/102 (4.9%) 5 1/42 (2.4%) 1 1/40 (2.5%) 1 1/62 (1.6%) 1 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Respiratory, thoracic and mediastinal disorders
    Oropharyngeal pain 0/104 (0%) 0 1/96 (1%) 1 5/102 (4.9%) 7 1/42 (2.4%) 1 0/40 (0%) 0 0/62 (0%) 0 1/5 (20%) 1 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0
    Vascular disorders
    Hypertension 3/104 (2.9%) 3 6/96 (6.3%) 7 4/102 (3.9%) 4 1/42 (2.4%) 1 1/40 (2.5%) 1 0/62 (0%) 0 0/5 (0%) 0 0/3 (0%) 0 0/5 (0%) 0 0/28 (0%) 0 0/5 (0%) 0

    Limitations/Caveats

    [Not Specified]

    More Information

    Certain Agreements

    Principal Investigators are NOT employed by the organization sponsoring the study.

    The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.

    Results Point of Contact

    Name/Title Chief Medical Officer
    Organization Eli Lilly and Company
    Phone 800-545-5979
    Email ClinicalTrials.gov@lilly.com
    Responsible Party:
    Eli Lilly and Company
    ClinicalTrials.gov Identifier:
    NCT02757352
    Other Study ID Numbers:
    • 16180
    • I1F-MC-RHBX
    • 2015-003938-27
    First Posted:
    May 2, 2016
    Last Update Posted:
    Mar 13, 2020
    Last Verified:
    Aug 1, 2019