A Study of Ixekizumab (LY2439821) in TNF Inhibitor Experienced Participants With Radiographic Axial Spondyloarthritis (COAST-W)

Lilly

Status and phase: Completed; Phase 3

Conditions: Spondyloarthritis

Treatments: Drug: Placebo; Drug: Ixekizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02696798

I1F-MC-RHBW (Other Identifier)

2015-003937-84 (EudraCT Number)

16179

Details and patient eligibility

About

The main purpose of this study is to evaluate the efficacy and safety of ixekizumab in tumor necrosis factor (TNF) inhibitor-experienced participants with radiographic axial spondyloarthritis (rad-axSpA).

Enrollment: 316 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Are ambulatory.
• Have an established 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.
• Have had prior treatment with at least 1 and not more than 2 TNF inhibitors.
• Must have had an inadequate response to 2 or more NSAIDs at the therapeutic dose range for a total duration of at least 4 weeks OR have a history of intolerance to NSAIDs.
• 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 never taken a TNF inhibitor medication or have taken more than 2.
• 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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316 participants in 3 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: Starting dose of 160 mg ixekizumab given SC at week 16 followed by 80 mg ixekizumab given SC Q2W or Q4W from week 16 to week 52.

Treatment:

Drug: Ixekizumab

Drug: Placebo