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

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ClinicalTrials.gov Identifier: NCT02757352
Recruitment Status : Completed
First Posted : May 2, 2016
Last Update Posted : August 27, 2019
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

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

Condition or disease Intervention/treatment Phase
Axial Spondyloarthritis Drug: Ixekizumab Drug: Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 305 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A 52-Week Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD Naive Patients With Nonradiographic Axial Spondyloarthritis
Actual Study Start Date : August 2, 2016
Actual Primary Completion Date : March 1, 2019
Actual Study Completion Date : May 7, 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Ixekizumab

Arm Intervention/treatment
Experimental: Q2W Ixekizumab
Ixekizumab given subcutaneously (SC) every two weeks (Q2W) to week 52.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Q4W Ixekizumab
Ixekizumab given SC every four weeks (Q4W) to week 52.
Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Placebo Comparator: Placebo
Placebo given SC Q2W to week 52.
Drug: Placebo
Administered SC




Primary Outcome Measures :
  1. Proportion of Participants Achieving an Assessment of Spondyloarthritis International Society 40 (ASAS40) Response [ Time Frame: Week 16 ]
  2. Proportion of Participants Achieving an ASAS40 Response [ Time Frame: Week 52 ]

Secondary Outcome Measures :
  1. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: Baseline, Week 16 ]
  2. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 16 ]
  3. 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 ]
  4. Percent of Participants without Clinically Meaningful Changes in Background Therapy [ Time Frame: Week 52 ]
  5. Change from Baseline in Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) [ Time Frame: Baseline, Week 52 ]
  6. Proportion of Participants Achieving ASDAS Inactive Disease [ Time Frame: Week 16 ]
  7. Change from Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 52 ]
  8. Change from Baseline in Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: Baseline, Week 52 ]
  9. Change from Baseline in Chest Expansion [ Time Frame: Baseline, Week 52 ]
  10. Change from Baseline in Occiput to Wall Distance [ Time Frame: Baseline, Week 52 ]
  11. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [ Time Frame: Baseline, Week 52 ]
  12. Change from Baseline in SPARCC Enthesitis Score [ Time Frame: Baseline, Week 52 ]
  13. Change from Baseline in Severity of Peripheral Arthritis by Tender (TJC) and Swollen Joint Count (SJC) Scores of 46/44 Joints [ Time Frame: Baseline, Week 52 ]
  14. Proportion of Participants with Anterior Uveitis or Uveitis Flares [ Time Frame: Baseline through Week 52 ]
  15. Change from Baseline in the Fatigue Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 52 ]
  16. Change from Baseline in ASAS Health Index (ASAS HI) [ Time Frame: Baseline, Week 52 ]
  17. Change from Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) [ Time Frame: Baseline, Week 52 ]
  18. Change from Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores [ Time Frame: Baseline, Week 52 ]
  19. Change from Baseline in 36-Item Short Form Health Survey (SF-36) Physical Component Summary (PCS) and Mental Component Summary (MCS) Scores [ Time Frame: Baseline, Week 52 ]
  20. Change from Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score [ Time Frame: Baseline, Week 52 ]
  21. Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Week 52 ]
  22. Pharmacokinetics (PK): Trough Concentration at Steady State (Ctrough ss) [ Time Frame: Week 52 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Are ambulatory.
  • Diagnosis of nonradiographic axial spondyloarthritis (nr-axSpA) and fulfilling the 2009 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 NRS at screening and baseline.
  • Have objective signs of inflammation by presence of sacroiliitis on MRI and/or presence of elevated 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02757352


  Show 108 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
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Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02757352     History of Changes
Other Study ID Numbers: 16180
I1F-MC-RHBX ( Other Identifier: Eli Lilly and Company )
2015-003938-27 ( EudraCT Number )
First Posted: May 2, 2016    Key Record Dates
Last Update Posted: August 27, 2019
Last Verified: August 1, 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
URL: https://vivli.org/
Keywords provided by Eli Lilly and Company:
ankylosing
nonradiographic spondyloarthritis
Additional relevant MeSH terms:
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Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Ixekizumab
Dermatologic Agents