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

Primary Purpose

Axial Spondyloarthritis

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ixekizumab

Placebo

About this trial

This is an interventional treatment trial for Axial Spondyloarthritis focused on measuring ankylosing, nonradiographic spondyloarthritis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arizona Arthritis Research, PLC
TriWest Research Assocaites
Rheumatology Center of San Diego
Care Access Research - Huntington Beach
Desert Medical Advances
Inlande Rheumatology Clinical Trials
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Clinical Research Center of CT/NY
Sarasota Arthritis Center
West Broward Rheumatology Associates, Inc
Marietta Rheumatology
Institute of Arthritis Research
The Arthritis & Diabetes Clinic Inc.
Osteoporosis And Clinical Trial Center
Osteoporosis And Clinical Trial Center
Glacier View Research Institute
Physician Research Collaboration, LLC
Weill Cornell Physicians at Brooklyn Heights
Shanahan Rheumatology & Immunotherapy
Carolina Arthritis Associates
Oregon Health and Science University
Altoona Center for Clinical Research
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Seattle Rheumatology Associates, P.L.L.C.
Arthritis Northwest Rheumatology
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Office: Perez-De Jesus, Amarilis
Ponce School of Medicine CAIMED Center
Mindful Medical Research
Latin Clinical Trial Center
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V.A. Nasonova Research Institute of Rheumatology
City Clinical Hospital #1
Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
Saratov Regional Clinical Hospital
Clinical Rheumatology Hospital # 25
Clinical Hospital for Emergency Care

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Arm Label

Q2W Ixekizumab

Q4W Ixekizumab

Placebo

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response

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

Percentage of Participants Achieving an ASAS40 Response

Secondary Outcome Measures

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

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

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

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

Number of Participants Without Clinically Meaningful Changes in Background Therapy

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

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

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

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

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

Percentage of Participants Achieving ASDAS Low Disease Activity

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

Percentage of Participants Achieving ASDAS Low Disease Activity

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

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

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score

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

Change From Baseline in SPARCC Enthesitis Score

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

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

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

Percentage of Participants Achieving ASDAS Inactive Disease

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

Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)

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

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

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

Change From Baseline in Chest Expansion

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

Change From Baseline in Occiput to Wall Distance

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

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

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

Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints

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

Number of Participants With Anterior Uveitis

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

Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score

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

Change From Baseline in ASAS Health Index (ASAS HI)

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

Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)

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

Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores

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

Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score

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

Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies

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

Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)

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

Full Information

NCT ID

NCT02757352

First Posted

April 28, 2016

Last Updated

February 28, 2020

Sponsor

Eli Lilly and Company

1. Study Identification

Unique Protocol Identification Number

NCT02757352

Brief Title

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

Acronym

COAST-X

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 1, 2019

Overall Recruitment Status

Completed

Study Start Date

August 2, 2016 (Actual)

Primary Completion Date

March 1, 2019 (Actual)

Study Completion Date

May 7, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

4. Oversight

Data Monitoring Committee

5. 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Axial Spondyloarthritis

Keywords

ankylosing, nonradiographic spondyloarthritis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

303 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Q2W Ixekizumab

Arm Type

Experimental

Arm Description

Arm Title

Q4W Ixekizumab

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ixekizumab

Other Intervention Name(s)

LY2439821

Intervention Description

Administered SC

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered SC

Primary Outcome Measure Information:

Title

Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving an ASAS40 Response

Description

Time Frame

Week 52

Secondary Outcome Measure Information:

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)

Description

Time Frame

Baseline, Week 52

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

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score

Description

Time Frame

Baseline, Week 52

Title

Percentage of Participants Achieving ASDAS Low Disease Activity

Description

Time Frame

Week 16

Title

Percentage of Participants Achieving ASDAS Low Disease Activity

Description

Time Frame

Week 52

Title

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score

Description

Time Frame

Baseline, Week 16

Title

Change From Baseline in SPARCC Enthesitis Score

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)

Description

Time Frame

Baseline, Week 52

Title

Percentage of Participants Achieving ASDAS Inactive Disease

Description

Time Frame

Week 52

Title

Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Chest Expansion

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Occiput to Wall Distance

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints

Description

Time Frame

Baseline, Week 52

Title

Number of Participants With Anterior Uveitis

Description

Time Frame

Baseline through Week 52

Title

Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in ASAS Health Index (ASAS HI)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores

Description

Time Frame

Baseline, Week 52

Title

Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score

Description

Time Frame

Baseline, Week 52

Title

Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies

Description

Time Frame

Week 52

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Are ambulatory. Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 Assessment of Spondyloarthritis International Society (ASAS) classification criteria. Have a history of back pain ≥3 months with age at onset <45 years. Have active nr-axSpA defined as BASDAI ≥4 and total back pain ≥4 on a numeric rating scale (NRS) at screening and baseline. Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated C-reactive protein (CRP). In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (NSAIDS) for duration of 4 weeks or cannot tolerate NSAIDS. If taking NSAIDS be on stable dose for at least 2 weeks prior to randomization. Have a history of prior therapy for axSpA for at least 12 weeks prior to screening. Exclusion Criteria: Have radiographic sacroiliitis fulfilling the 1984 modified New York criteria. Have received any prior, or are currently receiving treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents. Have received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year. Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis. Have a compromised immune system. Have any other serious and/or uncontrolled diseases. Have either a current diagnosis or a recent history of malignant disease. Have had major surgery within 8 weeks of baseline, or will require surgery during the study. Are pregnant or breastfeeding. Have evidence of active anterior uveitis (an acute episode) within the last 42 days prior to baseline randomization.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Arizona Arthritis Research, PLC

City

Phoenix

State/Province

Arizona

ZIP/Postal Code

85032

Country

United States

Facility Name

TriWest Research Assocaites

City

El Cajon

State/Province

California

ZIP/Postal Code

92020

Country

United States

Facility Name

Rheumatology Center of San Diego

City

Escondido

State/Province

California

ZIP/Postal Code

92025

Country

United States

Facility Name

Care Access Research - Huntington Beach

City

Huntington Beach

State/Province

California

ZIP/Postal Code

92648

Country

United States

Facility Name

Desert Medical Advances

City

Palm Desert

State/Province

California

ZIP/Postal Code

92260

Country

United States

Facility Name

Inlande Rheumatology Clinical Trials

City

Upland

State/Province

California

ZIP/Postal Code

91786

Country

United States

Facility Name

Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC

City

Colorado Springs

State/Province

Colorado

ZIP/Postal Code

80920

Country

United States

Facility Name

Clinical Research Center of CT/NY

City

Danbury

State/Province

Connecticut

ZIP/Postal Code

06810

Country

United States

Facility Name

Sarasota Arthritis Center

City

Sarasota

State/Province

Florida

ZIP/Postal Code

34239

Country

United States

Facility Name

West Broward Rheumatology Associates, Inc

City

Tamarac

State/Province

Florida

ZIP/Postal Code

33321

Country

United States

Facility Name

Marietta Rheumatology

City

Marietta

State/Province

Georgia

ZIP/Postal Code

30060

Country

United States

Facility Name

Institute of Arthritis Research

City

Idaho Falls

State/Province

Idaho

ZIP/Postal Code

83404

Country

United States

Facility Name

The Arthritis & Diabetes Clinic Inc.

City

Monroe

State/Province

Louisiana

ZIP/Postal Code

71203

Country

United States

Facility Name

Osteoporosis And Clinical Trial Center

City

Cumberland

State/Province

Maryland

ZIP/Postal Code

21502

Country

United States

Facility Name

Osteoporosis And Clinical Trial Center

City

Hagerstown

State/Province

Maryland

ZIP/Postal Code

21740

Country

United States

Facility Name

Glacier View Research Institute

City

Kalispell

State/Province

Montana

ZIP/Postal Code

59901

Country

United States

Facility Name

Physician Research Collaboration, LLC

City

Lincoln

State/Province

Nebraska

ZIP/Postal Code

68516

Country

United States

Facility Name

Weill Cornell Physicians at Brooklyn Heights

City

Brooklyn

State/Province

New York

ZIP/Postal Code

11201

Country

United States

Facility Name

Shanahan Rheumatology & Immunotherapy

City

Raleigh

State/Province

North Carolina

ZIP/Postal Code

27617

Country

United States

Facility Name

Carolina Arthritis Associates

City

Wilmington

State/Province

North Carolina

ZIP/Postal Code

28401

Country

United States

Facility Name

Oregon Health and Science University

City

Portland

State/Province

Oregon

ZIP/Postal Code

97239

Country

United States

Facility Name

Altoona Center for Clinical Research

City

Duncansville

State/Province

Pennsylvania

ZIP/Postal Code

16635

Country

United States

Facility Name

Articularis Healthcare Group, INC dba Columbia Arthritis Ctr

City

Columbia

State/Province

South Carolina

ZIP/Postal Code

29204

Country

United States

Facility Name

Seattle Rheumatology Associates, P.L.L.C.

City

Seattle

State/Province

Washington

ZIP/Postal Code

98122

Country

United States

Facility Name

Arthritis Northwest Rheumatology

City

Spokane

State/Province

Washington

ZIP/Postal Code

99204

Country

United States

Facility Name

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

City

Capital Federal

ZIP/Postal Code

C1430EGF

Country

Argentina

Facility Name

City

Ciudad Autonoma de Buenos Aire

ZIP/Postal Code

C1428DZF

Country

Argentina

Facility Name

City

Quilmes

ZIP/Postal Code

B1878DVC

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000CFJ

Country

Argentina

Facility Name

City

Rosario

ZIP/Postal Code

S2000DEJ

Country

Argentina

Facility Name

City

San Juan

ZIP/Postal Code

J5402DIL

Country

Argentina

Facility Name

City

San Miguel de Tucuman

ZIP/Postal Code

T4000AXL

Country

Argentina

Facility Name

City

San Miguel De Tucumán

ZIP/Postal Code

T4000BRD

Country

Argentina

Facility Name

City

Wien

ZIP/Postal Code

1060

Country

Austria

Facility Name

"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."

City

Wien

ZIP/Postal Code

1090

Country

Austria

Facility Name

City

Goiás

ZIP/Postal Code

74043-110

Country

Brazil

Facility Name

City

Juiz de Fora

ZIP/Postal Code

36010-570

Country

Brazil

Facility Name

City

Rio de Janeiro

ZIP/Postal Code

21941-913

Country

Brazil

Facility Name

City

Rio de Janeiro

ZIP/Postal Code

22271-100

Country

Brazil

Facility Name

City

Quebec

ZIP/Postal Code

G1V 3M7

Country

Canada

Facility Name

City

St. John's

ZIP/Postal Code

A1C 5B8

Country

Canada

Facility Name

City

Toronto

ZIP/Postal Code

M5T 2S8

Country

Canada

Facility Name

For additional information regarding investigative sites for this trial, contact 1-888-545-5972 Mon - Fri, 9 AM to 4 PM or 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri, 9 AM to 5 PM Eastern Time or speak with your personal physician.

City

Trois-Rivieres

ZIP/Postal Code

G8Z 1Y2

Country

Canada

Facility Name

City

Brno

ZIP/Postal Code

611 41

Country

Czechia

Facility Name

City

Ostrava

ZIP/Postal Code

703 00

Country

Czechia

Facility Name

City

Pardubice

ZIP/Postal Code

530 02

Country

Czechia

Facility Name

City

Praha 2

ZIP/Postal Code

128 50

Country

Czechia

Facility Name

City

Uherske Hradiste

ZIP/Postal Code

686 01

Country

Czechia

Facility Name

City

Helsinki

ZIP/Postal Code

00100

Country

Finland

Facility Name

City

Helsinki

ZIP/Postal Code

00290

Country

Finland

Facility Name

City

Hyvinkaa

ZIP/Postal Code

05800

Country

Finland

Facility Name

City

Kuopio

ZIP/Postal Code

70110

Country

Finland

Facility Name

City

Oulu

ZIP/Postal Code

90029

Country

Finland

Facility Name

City

Halle (Saale)

State/Province

Sachsen-Anhalt

ZIP/Postal Code

06108

Country

Germany

Facility Name

City

Bad Doberan

ZIP/Postal Code

18209

Country

Germany

Facility Name

City

Berlin

ZIP/Postal Code

10117

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

20095

Country

Germany

Facility Name

City

Hamburg

ZIP/Postal Code

22081

Country

Germany

Facility Name

City

Herne

ZIP/Postal Code

44649

Country

Germany

Facility Name

City

Bunkyo-ku

ZIP/Postal Code

113-8431

Country

Japan

Facility Name

City

Chuo-Ku

ZIP/Postal Code

104-8560

Country

Japan

Facility Name

City

Kita-gun

ZIP/Postal Code

761-0793

Country

Japan

Facility Name

City

Kuwana

ZIP/Postal Code

511-0061

Country

Japan

Facility Name

City

Nankoku

ZIP/Postal Code

783-8505

Country

Japan

Facility Name

City

Nishinomiya

ZIP/Postal Code

663-8501

Country

Japan

Facility Name

City

Okayama

ZIP/Postal Code

700-8607

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

534-0021

Country

Japan

Facility Name

City

Osaka

ZIP/Postal Code

545-8586

Country

Japan

Facility Name

City

Sapporo

ZIP/Postal Code

060-8648

Country

Japan

Facility Name

City

Sasebo

ZIP/Postal Code

857-1195

Country

Japan

Facility Name

City

Suita-shi

ZIP/Postal Code

565-0871

Country

Japan

Facility Name

City

Tenri

ZIP/Postal Code

632-8552

Country

Japan

Facility Name

City

Yamagata

ZIP/Postal Code

990-9585

Country

Japan

Facility Name

City

Ōsaka

ZIP/Postal Code

5340021

Country

Japan

Facility Name

City

Daejeon

ZIP/Postal Code

35015

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

02447

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

04763

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05030

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05278

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

05505

Country

Korea, Republic of

Facility Name

City

Seoul

ZIP/Postal Code

06273

Country

Korea, Republic of

Facility Name

City

Chihuahua

ZIP/Postal Code

31000

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44620

Country

Mexico

Facility Name

City

Guadalajara

ZIP/Postal Code

44650

Country

Mexico

Facility Name

City

Merida

ZIP/Postal Code

97070

Country

Mexico

Facility Name

City

Mexicali

ZIP/Postal Code

21200

Country

Mexico

Facility Name

City

Monterrey

ZIP/Postal Code

64460

Country

Mexico

Facility Name

City

San Luis Potosí

ZIP/Postal Code

78213

Country

Mexico

Facility Name

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

City

Elblag

ZIP/Postal Code

82-300

Country

Poland

Facility Name

City

Lodz

ZIP/Postal Code

90-558

Country

Poland

Facility Name

City

Nadarzyn

ZIP/Postal Code

05-830

Country

Poland

Facility Name

City

Poznan

ZIP/Postal Code

61-397

Country

Poland

Facility Name

City

Swidnik

ZIP/Postal Code

21-040

Country

Poland

Facility Name

City

Warsaw

ZIP/Postal Code

03-291

Country

Poland

Facility Name

Office: Perez-De Jesus, Amarilis

City

Caguas

ZIP/Postal Code

00725

Country

Puerto Rico

Facility Name

Ponce School of Medicine CAIMED Center

City

Ponce

ZIP/Postal Code

00716

Country

Puerto Rico

Facility Name

Mindful Medical Research

City

San Juan

ZIP/Postal Code

00918

Country

Puerto Rico

Facility Name

Latin Clinical Trial Center

City

Santurce

ZIP/Postal Code

00909

Country

Puerto Rico

Facility Name

City

Bucuresti

ZIP/Postal Code

011025

Country

Romania

Facility Name

City

Bucuresti

ZIP/Postal Code

011172

Country

Romania

Facility Name

City

Constanta

ZIP/Postal Code

900591

Country

Romania

Facility Name

V.A. Nasonova Research Institute of Rheumatology

City

Moscow

ZIP/Postal Code

115522

Country

Russian Federation

Facility Name

City Clinical Hospital #1

City

Moscow

ZIP/Postal Code

119049

Country

Russian Federation

Facility Name

Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary

City

Ryazan

ZIP/Postal Code

390026

Country

Russian Federation

Facility Name

Saratov Regional Clinical Hospital

City

Saratov

ZIP/Postal Code

410053

Country

Russian Federation

Facility Name

Clinical Rheumatology Hospital # 25

City

St. Petersburg

ZIP/Postal Code

190068

Country

Russian Federation

Facility Name

Clinical Hospital for Emergency Care

City

Yaroslavl

ZIP/Postal Code

150003

Country

Russian Federation

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

35429281

Citation

van der Horst-Bruinsma IE, de Vlam K, Walsh JA, Bolce R, Hunter T, Sandoval D, Zhu D, Geneus V, Soriano ER, Magrey M. Baseline Characteristics and Treatment Response to Ixekizumab Categorised by Sex in Radiographic and Non-radiographic Axial Spondylarthritis Through 52 Weeks: Data from Three Phase III Randomised Controlled Trials. Adv Ther. 2022 Jun;39(6):2806-2819. doi: 10.1007/s12325-022-02132-2. Epub 2022 Apr 16.

Results Reference

derived

PubMed Identifier

34560906

Citation

Deodhar A, Mease P, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Lauzon S, Leung A, Navarro-Compan V. Ixekizumab improves sleep and work productivity in patients with non-radiographic axial spondyloarthritis: results from the COAST-X trial at 52 weeks. BMC Rheumatol. 2021 Sep 25;5(1):50. doi: 10.1186/s41927-021-00218-y.

Results Reference

derived

PubMed Identifier

33284423

Citation

Deodhar A, Mease P, Rahman P, Navarro-Compan V, Marzo-Ortega H, Hunter T, Sandoval D, Kronbergs A, Leon L, Shan M, Leung A, De Vlam K, Strand V. Ixekizumab Improves Patient-Reported Outcomes in Non-Radiographic Axial Spondyloarthritis: Results from the Coast-X Trial. Rheumatol Ther. 2021 Mar;8(1):135-150. doi: 10.1007/s40744-020-00254-z. Epub 2020 Dec 7.

Results Reference

derived

PubMed Identifier

33044756

Citation

Walsh JA, Magrey MN, Baraliakos X, Inui K, Weng MY, Lubrano E, van der Heijde D, Boonen A, Gensler LS, Strand V, Braun J, Hunter T, Li X, Zhu B, Leon L, Calderon DMS, Kiltz U. Improvement of Functioning and Health With Ixekizumab in the Treatment of Active Nonradiographic Axial Spondyloarthritis in a 52-Week, Randomized, Controlled Trial. Arthritis Care Res (Hoboken). 2022 Mar;74(3):451-460. doi: 10.1002/acr.24482. Epub 2022 Jan 26.

Results Reference

derived

PubMed Identifier

31813637

Citation

Deodhar A, van der Heijde D, Gensler LS, Kim TH, Maksymowych WP, Ostergaard M, Poddubnyy D, Marzo-Ortega H, Bessette L, Tomita T, Leung A, Hojnik M, Gallo G, Li X, Adams D, Carlier H, Sieper J; COAST-X Study Group. Ixekizumab for patients with non-radiographic axial spondyloarthritis (COAST-X): a randomised, placebo-controlled trial. Lancet. 2020 Jan 4;395(10217):53-64. doi: 10.1016/S0140-6736(19)32971-X. Epub 2019 Dec 5.

Results Reference

derived

Links:

URL

http://www.lillytrialguide.com/en-US/studies/nonradiographic-axial%20spondyloarthritis/RHBX#?postal=

Description

Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)

Learn more about this trial

A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis

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