Axial SpondyloarthritisPhase 3COAST-XNCT02757352
A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis
A Phase 3 study testing Ixekizumab in people with Axial Spondyloarthritis, run by Eli Lilly and Company at 109 sites in 16 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Axial Spondyloarthritis
- What is being tested?
- Ixekizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 303 participants
- Where
- 109 sitesin 16 countries
- Study dates
- 2 Aug 2016to 7 May 2019
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
109 sites in 16 countries.
109 sites in 16 countries
United States25 sites
Weill Cornell Physicians at Brooklyn Heights
Brooklyn, New York, 11201
Arthritis Assoc. & Osteoporosis Ctr of Colorado Springs, LLC
Colorado Springs, Colorado, 80920
Articularis Healthcare Group, INC dba Columbia Arthritis Ctr
Columbia, South Carolina, 29204
Osteoporosis And Clinical Trial Center
Cumberland, Maryland, 21502
Clinical Research Center of CT/NY
Danbury, Connecticut, 06810
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
TriWest Research Assocaites
El Cajon, California, 92020
Rheumatology Center of San Diego
Escondido, California, 92025
Osteoporosis And Clinical Trial Center
Hagerstown, Maryland, 21740
Care Access Research - Huntington Beach
Huntington Beach, California, 92648
Institute of Arthritis Research
Idaho Falls, Idaho, 83404
Glacier View Research Institute
Kalispell, Montana, 59901
Physician Research Collaboration, LLC
Lincoln, Nebraska, 68516
Marietta Rheumatology
Marietta, Georgia, 30060
The Arthritis & Diabetes Clinic Inc.
Monroe, Louisiana, 71203
Desert Medical Advances
Palm Desert, California, 92260
Arizona Arthritis Research, PLC
Phoenix, Arizona, 85032
Oregon Health and Science University
Portland, Oregon, 97239
Shanahan Rheumatology & Immunotherapy
Raleigh, North Carolina, 27617
Sarasota Arthritis Center
Sarasota, Florida, 34239
Seattle Rheumatology Associates, P.L.L.C.
Seattle, Washington, 98122
Arthritis Northwest Rheumatology
Spokane, Washington, 99204
West Broward Rheumatology Associates, Inc
Tamarac, Florida, 33321
Inlande Rheumatology Clinical Trials
Upland, California, 91786
Carolina Arthritis Associates
Wilmington, North Carolina, 28401
Japan15 sites
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Bunkyō City, 113-8431
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Chūōku, 104-8560
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Kita-gun, 761-0793
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Kuwana, 511-0061
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Nankoku, 783-8505
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Nishinomiya, 663-8501
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Okayama, 700-8607
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Osaka, 534-0021
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Osaka, 545-8586
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Ōsaka, 5340021
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Sapporo, 060-8648
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Sasebo, 857-1195
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Suita-shi, 565-0871
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Tenri, 632-8552
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Yamagata, 990-9585
Argentina8 sites
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Capital Federal, C1430EGF
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Ciudad Autonoma de Buenos Aire, C1428DZF
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Quilmes, B1878DVC
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Rosario, S2000CFJ
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Rosario, S2000DEJ
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San Juan, J5402DIL
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San Miguel de Tucumán, T4000AXL
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San Miguel de Tucumán, T4000BRD
South Korea8 sites
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Daejeon, 35015
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Seoul, 02447
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Seoul, 03080
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Seoul, 04763
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Seoul, 05030
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Seoul, 05278
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Seoul, 05505
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Seoul, 06273
Mexico7 sites
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Chihuahua City, 31000
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Guadalajara, 44620
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Guadalajara, 44650
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Mérida, 97070
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Mexicali, 21200
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Monterrey, 64460
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San Luis Potosí City, 78213
Germany6 sites
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Bad Doberan, 18209
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Berlin, 10117
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Halle, Saxony-Anhalt, 06108
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Hamburg, 20095
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Hamburg, 22081
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Herne, 44649
Poland6 sites
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Elblag, 82-300
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Lodz, 90-558
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Nadarzyn, 05-830
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Poznan, 61-397
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Świdnik, 21-040
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Warsaw, 03-291
Russia6 sites
V.A. Nasonova Research Institute of Rheumatology
Moscow, 115522
City Clinical Hospital #1
Moscow, 119049
Ryazan State Medical University/Ryazan Clinical Regional Cardiological Dispensary
Ryazan, 390026
Clinical Rheumatology Hospital # 25
Saint Petersburg, 190068
Saratov Regional Clinical Hospital
Saratov, 410053
Clinical Hospital for Emergency Care
Yaroslavl, 150003
Czechia5 sites
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Brno, 611 41
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Ostrava, 703 00
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Pardubice, 530 02
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Prague, 128 50
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Uherské Hradiště, 686 01
Finland5 sites
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Helsinki, 00100
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Helsinki, 00290
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Hyvinkää, 05800
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Kuopio, 70110
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Oulu, 90029
Brazil4 sites
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Goiás, 74043-110
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Juiz de Fora, 36010-570
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Rio de Janeiro, 21941-913
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Rio de Janeiro, 22271-100
Canada4 sites
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Québec, G1V 3M7
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St. John's, A1C 5B8
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Toronto, M5T 2S8
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Trois-Rivières, G8Z 1Y2
Puerto Rico4 sites
Office: Perez-De Jesus, Amarilis
Caguas, PR, 00725
Ponce School of Medicine CAIMED Center
Ponce, PR, 00716
Mindful Medical Research
San Juan, PR, 00918
Latin Clinical Trial Center
Santurce, 00909
Romania3 sites
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Bucharest, 011025
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Bucharest, 011172
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Constanța, 900591
Austria2 sites
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Vienna, 1060
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Vienna, 1090
Netherlands1 site
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Amsterdam, 1105 AZ
About this study
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
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).
- Conditions
- Axial Spondyloarthritis
- Being tested
- Ixekizumab, Placebo
- Keywords
- ankylosing, nonradiographic spondyloarthritis
- Medical subject headings
- Axial Spondyloarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IxekizumabDrug
Also called LY2439821
Administered SC
PlaceboDrug
Administered SC
| Study group | Role | What they receive |
|---|---|---|
| Q2W Ixekizumab | Experimental | Participants received a starting dose of 80 or 160 milligram (mg) of ixekizumab given subcutaneously (SC) at week 0 followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 52 during the double-blind period.
Inadequate responders (IR) as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44. Receives: Drug: Ixekizumab |
| Q4W Ixekizumab | Experimental | Participants received a starting dose of 80 or 160 mg of ixekizumab given SC at week 0 followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 52 during the double-blind period.
Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label week 16 and 44. Receives: Drug: Ixekizumab |
| Placebo | Placebo comparator | Participants received placebo as 2 SC injections Q2W to week 52 during double-blind period.
Inadequate responders as determined by investigators could switch to ixekizumab 80 mg Q2W open label between week 16 and 44. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Week 16
Percentage of Participants Achieving an ASAS40 Response
ASAS40 is defined as a greater than or equal to (≥)40% improvement and an absolute improvement from baseline of ≥2 units (ranges 0 to 10) in at least 3 of the 4 domains (Patient Global, Spinal Pain, Function, and Inflammation), without any worsening in the remaining domain. 1) Patient Global: How active was your spondylitis during the last week? score ranges 0 (not active) to 10 (very active). 2) Spinal Pain: How much spinal pain due to Ankylosing spondylitis? score ranges 0 (no pain) to 10 (severe pain). 3) Bath Ankylosing Spondylitis Functional Index: Participant is asked to rate the difficulty associated with 10 individual basic functional activities. Responses were captured using numeric rating scale (NRS) (ranges 0 to 10) with a higher score of worse function. 4) Inflammation based on mean of Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) question 5 and 6 (mean of intensity, duration of stiffness). Score ranges (0 (non) to 10 (very severe).
Measured: Week 52
Secondary outcomes (27)
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.
Measured: Baseline, Week 16
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
ASDAS is a composite index to assess disease activity in axSpA. ASDAS parameters used (with CRP as acute phase reactant) are: 1 )Total back pain 2) Patient global 3) Peripheral pain/swelling 4) Duration of morning stiffness 5) CRP in mg/L: ASDAScrp is calculated with the following equation: 0.121 × total back pain + 0.110 × patient global + 0.073 × peripheral pain/swelling + 0.058 × duration of morning stiffness + 0.579 × Ln(CRP+1). CRP is in milligram/liter (mg/L), the range of other variables is from 0 to 10. Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher scores indicated higher disease activity. Ln represents the natural logarithm. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Number of Participants Without Clinically Meaningful Changes in Background Therapy
Number of participants without changes in background therapy while on originally randomized treatment.
Measured: Baseline through Week 52
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The SF-36 is a 36-item patient-administered measure designed to be a short, multipurpose assessment of health in the areas of physical functioning, role - physical, role - emotional, bodily pain, vitality, social functioning, mental health, and general health. The Physical Component Summary score ranges from 0 to 100; higher scores indicate better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 16
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
The medical outcomes study 36-item short-form health survey (SF-36) SF-36 PCS are summarized using the t-scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Percentage of Participants Achieving ASDAS Low Disease Activity
ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Measured: Week 16
Percentage of Participants Achieving ASDAS Low Disease Activity
ASDAS is a composite index to assess disease activity in axSpA. ASDAS low disease activity is defined as a score of <2.1. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Measured: Week 52
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 16
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
The BASDAI is a participant-reported assessment consisting of 6 questions that relate to 5 major symptoms relevant to axial spondyloarthritis (axSpA): 1) Fatigue, 2) Spinal pain, 3) Peripheral arthritis, 4) Enthesitis, 5) Intensity, and 6) Duration of morning stiffness. Participants need to score each item with a score from 0 to 10 (NRS). Total score is obtained from the average of symptom scores ranging 0 (no problem) to 10 (worst problem), with a higher score indicating more severe AS symptom. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Both left and right SIJ are scored for bone marrow edema. Each side has 6 slices and each slice has 6 scoring units, and each scoring unit has a score of 0 or 1. Total SIJ SPARCC scores can range from 0 to 72 with higher scores reflecting worse disease. LS Mean was derived from ANCOVA model with treatment, geographic region, screening MRI/CRP status and baseline value as fixed factors.
Measured: Baseline, Week 16
Change From Baseline in SPARCC Enthesitis Score
The SPARCC enthesitis is an index used to measure the severity of enthesitis. The SPARCC assesses 16 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed include Medial epicondyle (left/right [L/R]), Lateral epicondyle (L/R), Supraspinatus insertion into greater tuberosity of humerus (L/R), Greater trochanter (L/R), Quadriceps insertion into superior border of patella (L/R), Patellar ligament insertion into inferior pole of patella or tibial tubercle (L/R), Achilles tendon insertion into calcaneum (L/R), and Plantar fascia insertion into calcaneum (L/R). The SPARCC is the sum of all site scores (range 0 to 16). Higher scores indicate more severe enthesitis. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value visit, baseline value-by-visit and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
BASFI is a participant-reported assessment that establishes a participant's functional baseline and subsequent response to treatment. Participants were asked to rate the difficulty associated with 10 individual basic functional activities. Participant responded to each question using a NRS scale (range 0 to 10), with a higher score indicating worse functioning. The participant's final BASFI score is the mean of the 10 item scores with the minimum value of 0 and a possible maximum value of 10, with a higher score indicating worse function. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Percentage of Participants Achieving ASDAS Inactive Disease
ASDAS is a composite index to assess disease activity in axSpA. ASDAS Inactive Disease is defined as a score of less than (<)1.3. The parameters used for the ASDAS (with CRP as acute phase reactant) are total back pain, patient global, peripheral pain/swelling, duration of morning stiffness and CRP in mg/L. The ASDAScrp is calculated with the following equation: 0.121×total back pain+0.110×patient global+0.073×peripheral pain/swelling+0.058×duration of morning stiffness+0.579×Ln(CRP+1). (CRP is in mg/liter, the range of other variables is from 0(normal) to 10(very severe); Ln represents the natural logarithm). Data from five variables combined to yield a score (0.6361 to no defined upper limit), where higher the score worse the disease activity.
Measured: Week 52
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
High-sensitivity C-reactive protein (hs-CRP) was the measure of acute phase reactant and was measured with a high sensitivity assay at the central laboratory to help assess the effect of ixekizumab on disease activity. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Bath Ankylosing Spondylitis Metrology Index (BASMI) is a combined index comprising the following 5 clinical measurements of spinal mobility in participants with axSpA: 1) Lateral spinal flexion 2) Tragus-to-wall distance 3) Lumbar flexion (modified Schrober) 4) Maximal intermalleolar distance, and 5) Cervical rotation. The BASMI includes these 5 measurements that were each scaled to a score of 0 to 10 depending on the result of the assessment (BASMI linear function). The average score of the 5 assessments gives the BASMI linear result. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Chest Expansion
While participants have their hands resting on or behind the head, the assessor has measured the chest's encircled length by centimeter at the fourth intercostal level anteriorly. The difference between maximal inspiration and expiration in centimeters was recorded. Two tries were recorded. The better measurement (larger difference) of 2 tries (in centimeters) was used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Occiput to Wall Distance
The participant is to make a maximum effort to touch the head against the wall when standing with heels and back against the wall (occiput). Then the distance from occiput to wall is measured. Two tries will be recorded. The better (smaller) measurement of 2 tries (in centimeters) will be used for analyses. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) is an index used to measure the severity of enthesitis. The MASES assesses 13 sites for enthesitis using a score of "0" for no activity or "1" for activity. Sites assessed included costochondral 1 (right/left [R/L]), costochondral 7 (R/L), spinal iliaca anterior superior (R/L), crista iliaca (R/L), spina iliaca posterior (R/L), processus spinosus L5, and achilles tendon proximal insertion (R/L). The MASES is the sum of all site scores (range 0 to 13); higher scores indicate more severe enthesitis. LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints
The number of tender and painful joints was determined by examination of 46 joints (23 joints on each side of the participants body). The 46 joints are assessed and classified as tender or not tender. Sum of all joints checked to be tender/painful divided by number of evaluable joints which is multiplied by 46 to obtain TJC score. The scores ranges from 0 (no tender/painful joints) to 46 (all joints tender/painful). Swollen joint count SJC was determined by examination of 44 joints (22 joints on each side of the participants body). The joints are classified as swollen or not swollen. Sum of all joints checked to be swollen divided by number of evaluable joints which is multiplied by 44 to obtain SJC score. Score ranges from 0 (not swollen) to 44 (all joints swollen). LS mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status and baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Number of Participants With Anterior Uveitis
Number of participants with anterior uveitis. Anterior uveitis is an inflammation of the middle layer of the eye which includes the iris (colored part of the eye) and the adjacent tissue, known as the ciliary body.
Measured: Baseline through Week 52
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
The Fatigue Severity NRS is a participant-administered, single-item, 11-point horizontal scale anchored at 0 and 10, with 0 representing "no fatigue" and 10 representing "as bad as you can imagine". Participants rate their fatigue (feeling tired or worn out) by circling the one number that describes their worst level of fatigue during the previous 24 hours. LS Mean was derived from MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in ASAS Health Index (ASAS HI)
ASAS-HI is a disease-specific health-index instrument designed to assess the impact of interventions for SpA, including axSpA. The 17-item instrument has scores ranging from 0 (good health) to 17 (poor health). Each item consists of one question that the participant needs to respond to with either "I agree" (score of 1) or "I do not agree" (score of 0). A score of "1" is given where the item is affirmed, indicating adverse health. All item scores are summed to give a total score or index. LS Mean was derived MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
Jenkins Sleep Evaluation Questionnaire (JSEQ) is a 4 item scale designed to estimate sleep problems in clinical research. The JSEQ assesses the frequency of sleep disturbance in 4 categories: 1) trouble falling asleep, 2) waking up several times during the night, 3) having trouble staying asleep (including waking up far too early), and 4) waking up after the usual amount of sleep feeling tired and worn out. Patients report the numbers of days they experience each of these problems in the past month on a 6 point Likert Scale ranging from 0 = "no days" to 5 = "22-30 days. The total JSEQ score ranges from 0 to 20, with higher scores indicating greater sleep disturbance. LS Mean was derived from using MMRM with treatment, geographic region, screening MRI/CRP status, baseline value, visit, baseline value-by-visit, and treatment-by-visit interaction as fixed factors.
Measured: Baseline, Week 52
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
The WPAI-SpA consists of 6 questions to determine employment status, hours missed from work because of SpA, hours missed from work for other reasons, hours actually worked, the degree to which SpA affected work productivity while at work, and the degree to which SpA affected activities outside of work. The WPAI-SpA has been validated in the rad-axSpA patient population. Four scores are derived: percentage of absenteeism, percentage of presenteeism (reduced productivity while at work), an overall work impairment score that combines absenteeism and presenteeism, and percentage of impairment in activities performed outside of work. The computed percentage range for each sub-scale was from 0-100, with higher scores indicating greater impairment and less productivity. LS Mean was derived from ANCOVA with treatment, geographic region, screening MRI/CRP status and baseline value.
Measured: Baseline, Week 52
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
ASAS-NSAID score is used to present the NSAID intake by considering the type of NSAID, the total dose, \& the number of days taking NSAID during a period of interest (PI). For NSAID equivalent scoring system, range is from 0 to 100, the higher the score, the greater the NSAID intake. ASAS-NSAID score= (equivalent NSAID score) x (days of intake during PI) x (days per week)/(PI in days).
Measured: Baseline, Week 52
Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies
A treatment-emergent positive anti-drug antibody (TE-ADA+) participant will be defined as a 4-fold increase over a positive baseline antibody titer (Tier 3); or for a negative baseline titer, a participant with an increase from the baseline to a level of ≥ 1:10.
Measured: Week 52
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
PK trough serum concentration samples were collected at steady state (Ctrough ss)
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2016 (estimated)
- Study start2 Aug 2016
- Primary completion1 Mar 2019
- Study completion7 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Axial SpondyloarthritisStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 303 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02757352
- Sponsor's protocol ID
- 16180
- Other IDs
- I1F-MC-RHBX, 2015-003938-27, 2015
- Acronym
- COAST-X
- Status last verified
- 1 Aug 2019
- First submitted
- 28 Apr 2016
- Last updated
- 13 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Publications
Reveille JD, Rudwaleit M, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Ng KJ, Gibble TH, Lisse J, Park SY, Kronbergs A, Navarro-Compan V. Does HLA-B27 Status Influence Ixekizumab Efficacy in Axial Spondyloarthritis? Results From the COAST-V, COAST-W, and COAST-X Trials. Rheumatol Ther. 2026 Feb;13(1):279-291. doi: 10.1007/s40744-025-00810-5. Epub 2025 Dec 19.
PubMed 41417207Navarro-Compan V, Reveille JD, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Panni T, Kronbergs A, Rudwaleit M. Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration. Adv Ther. 2025 Sep;42(9):4706-4716. doi: 10.1007/s12325-025-03305-5. Epub 2025 Jul 22.
PubMed 40694276Maksymowych WP, Baraliakos X, Lambert RG, Landewe R, Sandoval D, Carlier H, Lisse J, Li X, Hojnik M, Ostergaard M. Effects of ixekizumab treatment on structural changes in the sacroiliac joint: MRI assessments at 16 weeks in patients with non-radiographic axial spondyloarthritis. Lancet Rheumatol. 2022 Sep;4(9):e626-e634. doi: 10.1016/S2665-9913(22)00185-0. Epub 2022 Aug 9.
PubMed 38288892Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
PubMed 36792107Ortolan A, Ramiro S, Ramonda R, van der Heijde D. External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab. Rheumatology (Oxford). 2023 Jun 1;62(6):2257-2261. doi: 10.1093/rheumatology/keac618.
PubMed 36282526van 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.
PubMed 35429281Deodhar 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.
PubMed 34560906Deodhar 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.
PubMed 33284423Walsh 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.
PubMed 33044756Deodhar 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.
PubMed 31813637
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02757352
- Acronym / sponsor ID
- COAST-X / 16180
- Conditions
- Axial Spondyloarthritis
- Keywords
- ankylosing, nonradiographic spondyloarthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Eli Lilly and CompanyIndustry (pharma, biotech, devices)
- Study start
- 2 Aug 2016 (actual)
- Primary completion
- 1 Mar 2019 (actual)
- Study completion
- 7 May 2019 (actual)
- First posted
- 2 May 2016 (estimated)
- Results
- Posted 13 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Q2W Ixekizumab | Experimental | Drug: IxekizumabParticipants 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. |
| Q4W Ixekizumab | Experimental | Drug: IxekizumabParticipants 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. |
| Placebo | Placebo comparator | Drug: PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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).
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IxekizumabAlso: LY2439821Administered SC | Drug | Q2W Ixekizumab, Q4W Ixekizumab |
| PlaceboAdministered SC | Drug | Placebo |
Primary outcome
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response
Time frame: 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).
Percentage of Participants Achieving an ASAS40 Response
Time frame: 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).
27 secondary outcomes
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Baseline, Week 16
Change From Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS)
Time frame: Baseline, Week 52
Number of Participants Without Clinically Meaningful Changes in Background Therapy
Time frame: Baseline through Week 52
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Time frame: Baseline, Week 16
Change From Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) Score
Time frame: Baseline, Week 52
Percentage of Participants Achieving ASDAS Low Disease Activity
Time frame: Week 16
Percentage of Participants Achieving ASDAS Low Disease Activity
Time frame: Week 52
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, Week 16
Change From Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Time frame: Baseline, Week 52
Change From Baseline in Magnetic Resonance Imaging (MRI) of the Sacroiliac Joint (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score
Time frame: Baseline, Week 16
Change From Baseline in SPARCC Enthesitis Score
Time frame: Baseline, Week 52
Change From Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI)
Time frame: Baseline, Week 52
Percentage of Participants Achieving ASDAS Inactive Disease
Time frame: Week 52
Change From Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP)
Time frame: Baseline, Week 52
Change From Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI)
Time frame: Baseline, Week 52
Change From Baseline in Chest Expansion
Time frame: Baseline, Week 52
Change From Baseline in Occiput to Wall Distance
Time frame: Baseline, Week 52
Change From Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES)
Time frame: Baseline, Week 52
Change From Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 44 Joints
Time frame: Baseline, Week 52
Number of Participants With Anterior Uveitis
Time frame: Baseline through Week 52
Change From Baseline in the Fatigue Numeric Rating Scale (NRS) Score
Time frame: Baseline, Week 52
Change From Baseline in ASAS Health Index (ASAS HI)
Time frame: Baseline, Week 52
Change From Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ)
Time frame: Baseline, Week 52
Change From Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores
Time frame: Baseline, Week 52
Change From Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score
Time frame: Baseline, Week 52
Number of Participants With Treatment Emergent (TE) Anti-Ixekizumab Antibodies
Time frame: Week 52
Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss)
Time frame: Week 52
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 41417207Reveille JD, Rudwaleit M, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Ng KJ, Gibble TH, Lisse J, Park SY, Kronbergs A, Navarro-Compan V. Does HLA-B27 Status Influence Ixekizumab Efficacy in Axial Spondyloarthritis? Results From the COAST-V, COAST-W, and COAST-X Trials. Rheumatol Ther. 2026 Feb;13(1):279-291. doi: 10.1007/s40744-025-00810-5. Epub 2025 Dec 19.
- Derived from this study: PubMed 40694276Navarro-Compan V, Reveille JD, Rahman P, Maldonado-Cocco JA, Magrey M, Bolce R, Panni T, Kronbergs A, Rudwaleit M. Ixekizumab Improves Signs, Symptoms, and Quality of Life in Patients with Axial Spondyloarthritis Irrespective of Symptom Duration. Adv Ther. 2025 Sep;42(9):4706-4716. doi: 10.1007/s12325-025-03305-5. Epub 2025 Jul 22.
- Derived from this study: PubMed 38288892Maksymowych WP, Baraliakos X, Lambert RG, Landewe R, Sandoval D, Carlier H, Lisse J, Li X, Hojnik M, Ostergaard M. Effects of ixekizumab treatment on structural changes in the sacroiliac joint: MRI assessments at 16 weeks in patients with non-radiographic axial spondyloarthritis. Lancet Rheumatol. 2022 Sep;4(9):e626-e634. doi: 10.1016/S2665-9913(22)00185-0. Epub 2022 Aug 9.
- Derived from this study: PubMed 36792107Deodhar A, Poddubnyy D, Rahman P, Ermann J, Tomita T, Bolce R, Leage SL, Kronbergs A, Johnson C, Araujo J, Leung A, van der Heijde D. Long-Term Safety and Efficacy of Ixekizumab in Patients With Axial Spondyloarthritis: 3-year Data From the COAST Program. J Rheumatol. 2023 Aug;50(8):1020-1028. doi: 10.3899/jrheum.221022. Epub 2023 Feb 15.
- Derived from this study: PubMed 36282526Ortolan A, Ramiro S, Ramonda R, van der Heijde D. External validation of the alternative Ankylosing Spondylitis Disease Activity Score in three randomized clinical trials of ixekizumab. Rheumatology (Oxford). 2023 Jun 1;62(6):2257-2261. doi: 10.1093/rheumatology/keac618.
- Derived from this study: PubMed 35429281van 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.
- Derived from this study: PubMed 34560906Deodhar 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.
- Derived from this study: PubMed 33284423Deodhar 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.
- Derived from this study: PubMed 33044756Walsh 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.
- Derived from this study: PubMed 31813637Deodhar 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.
- Click here for more information about this study: A Study of Ixekizumab (LY2439821) in Participants With Nonradiographic Axial Spondyloarthritis (COAST-X)Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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) study director
Eli Lilly and Company
109 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Ixekizumab in people with Axial Spondyloarthritis, run by Eli Lilly and Company at 109 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 109 sites in United States, Japan, Argentina, South Korea, Mexico and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response (time frame: Week 16). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02757352, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Mar 2020.