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Trial record 5 of 29 for:    LY2439821

A Study of Ixekizumab (LY2439821) in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis (COAST-V)

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ClinicalTrials.gov Identifier: NCT02696785
Recruitment Status : Completed
First Posted : March 2, 2016
Last Update Posted : November 28, 2018
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 biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 320 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients With Radiographic Axial Spondyloarthritis
Actual Study Start Date : May 2, 2016
Actual Primary Completion Date : December 8, 2017
Actual Study Completion Date : October 17, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Q2W Ixekizumab

Double Blind Period: Starting dose of 80 or 160 milligrams (mg) ixekizumab given subcutaneously (SC) at baseline followed by 80 mg ixekizumab given SC every two weeks (Q2W) to week 14.

Extended Treatment Period: 80 mg ixekizumab given SC Q2W from week 16 to week 52.

Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Experimental: Q4W Ixekizumab

Double Blind Period: Starting dose of 80 or 160 mg ixekizumab given SC at baseline followed by 80 mg ixekizumab given SC every four weeks (Q4W) to week 14.

Extended Treatment Period: 80 mg ixekizumab given SC Q4W from week 16 to week 52.

Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Placebo Comparator: Placebo

Double Blind Period: Placebo given SC Q2W to week 14.

Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.

Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Drug: Placebo
Administered SC

Active Comparator: Adalimumab

Double Blind Period: 40 mg Adalimumab given SC Q2W to week 14.

Extended Treatment Period: 80 mg ixekizumab given SC Q2W or Q4W from week 20 to week 52.

Drug: Ixekizumab
Administered SC
Other Name: LY2439821

Drug: Adalimumab
Administered SC




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

Secondary Outcome Measures :
  1. Proportion of Participants Achieving an ASAS20 Response [ Time Frame: Week 16 ]
  2. Change from Baseline in Ankylosing Spondylitis Disease Activity Score (ASDAS) [ Time Frame: Baseline, Week 16 ]
  3. Proportion of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index 50 (BASDAI50) Response [ Time Frame: Week 16 ]
  4. Change from Baseline in Bath Ankylosing Spondylitis Functional Index (BASFI) [ Time Frame: Baseline, Week 16 ]
  5. Proportion of Participants Achieving ASDAS Inactive Disease [ Time Frame: Week 16 ]
  6. Change from Baseline in Magnetic Resonance Imaging (MRI) of the Spine (Ankylosing Spondylitis Spinal Magnetic Resonance Imaging [ASSpiMRI] - Berlin Score) [ Time Frame: Baseline, Week 16 ]
  7. 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 16 ]
  8. Change from Baseline in ASAS Health Index (ASAS HI) [ Time Frame: Baseline, Week 16 ]
  9. Change from Baseline in the Measure of High Sensitivity C-Reactive Protein (CRP) [ Time Frame: Baseline, Week 16 ]
  10. Change from Baseline in Mobility on the Bath Ankylosing Spondylitis Metrology Index (BASMI) [ Time Frame: Baseline, Week 16 ]
  11. Change from Baseline in Chest Expansion [ Time Frame: Baseline, Week 16 ]
  12. Change from Baseline in Occiput to Wall Distance [ Time Frame: Baseline, Week 16 ]
  13. Change from Baseline in MRI sacroiliac joint(s) (SIJ) Spondyloarthritis Research Consortium of Canada (SPARCC) Score [ Time Frame: Baseline, Week 16 ]
  14. Change from Baseline in Maastricht Ankylosing Spondylitis Enthesitis Score (MASES) [ Time Frame: Baseline, Week 16 ]
  15. Change from Baseline in SPARCC Enthesitis Score [ Time Frame: Baseline, Week 16 ]
  16. 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 16 ]
  17. Proportion of Participants with Anterior Uveitis or Uveitis Flares [ Time Frame: Baseline through Week 16 ]
  18. Change from Baseline in the Fatigue Numeric Rating Scale (NRS) Score [ Time Frame: Baseline, Week 16 ]
  19. Change from Baseline in the Jenkins Sleep Evaluation Questionnaire (JSEQ) [ Time Frame: Baseline, Week 16 ]
  20. Change from Baseline in the Work Productivity Activity Impairment Spondyloarthritis (WPAI-SpA) Scores [ Time Frame: Baseline, Week 16 ]
  21. Change from Baseline in ASAS-Nonsteroidal Anti-Inflammatory Drug (NSAID) Score [ Time Frame: Baseline, Week 52 ]
  22. Number of Participants with Anti-Ixekizumab Antibodies [ Time Frame: Week 16 ]
  23. Pharmacokinetics: Trough Ixekizumab Concentration at Steady State (Ctrough ss) [ Time Frame: Week 16 ]


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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 radiographic axial spondyloarthritis (rad-xSpA) with sacroiliitis defined radiographically according to the modified New York criteria.
  • Participants have a history of back pain ≥3 months with age at onset <45 years.
  • In the past had an inadequate response to at least 2 non-steroidal anti-inflammatory drugs (for duration 4 weeks) or cannot tolerate NSAIDS.
  • If taking NSAIDS be on a stable dose for at least 2 weeks prior to randomization.
  • Have a history of prior therapy for axSpa for at least 12 weeks prior to screening.

Exclusion Criteria:

  • Have total ankylosis of the spine.
  • Have received any prior, or are currently receiving, treatment with biologics, tumor necrosis factor inhibitors or other immunomodulatory agents.
  • Have recently received a live vaccine within 12 weeks or have had a vaccination with Bacillus Calmette-Guerin (BCG) within the past year.
  • Have an ongoing or serious infection within the last 12 weeks or evidence of active tuberculosis.
  • Have a compromised immune system.
  • Have any other serious and/or uncontrolled diseases.
  • Have either a current diagnosis or a recent history of malignant disease.
  • Have had major surgery within 8 weeks of baseline, or will require surgery during the study.
  • Are pregnant or breastfeeding.

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): NCT02696785


  Show 28 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company

Additional Information:
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT02696785     History of Changes
Other Study ID Numbers: 16178
I1F-MC-RHBV ( Other Identifier: Eli Lilly and Company )
2015-003932-11 ( EudraCT Number )
First Posted: March 2, 2016    Key Record Dates
Last Update Posted: November 28, 2018
Last Verified: November 2018

Keywords provided by Eli Lilly and Company:
Ankylosing Spondylitis

Additional relevant MeSH terms:
Spondylarthritis
Spondylitis
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases
Arthritis
Joint Diseases
Adalimumab
Ixekizumab
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents