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

Lilly

Status and phase: Completed; Phase 3

Conditions: Spondyloarthritis

Treatments: Drug: Placebo; Drug: Adalimumab; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02696785

I1F-MC-RHBV (Other Identifier)

16178

2015-003932-11 (EudraCT Number)

Details and patient eligibility

About

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).

Enrollment: 341 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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341 participants in 4 patient groups, including a placebo group

Q2W Ixekizumab

Experimental group

Description:

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.

Treatment:

Drug: Ixekizumab

Q4W Ixekizumab

Experimental group

Description:

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.

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Ixekizumab

Drug: Placebo

Adalimumab

Active Comparator group

Description:

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.

Treatment:

Drug: Adalimumab

Drug: Ixekizumab