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

Lilly

Status and phase: Completed; Phase 3

Conditions: Axial Spondyloarthritis

Treatments: Drug: Ixekizumab; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT02757352

I1F-MC-RHBX (Other Identifier)

2015-003938-27 (EudraCT Number)

16180

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 biologic disease modifying antirheumatic drug (bDMARD) naïve participants with nonradiographic axial spondyloarthritis (nonrad-axSpA).

Enrollment: 303 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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303 participants in 3 patient groups, including a placebo group

Q2W Ixekizumab

Experimental group

Description:

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.

Treatment:

Drug: Ixekizumab

Q4W Ixekizumab

Experimental group

Description:

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.

Treatment:

Drug: Ixekizumab

Placebo

Placebo Comparator group

Description:

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.

Treatment:

Drug: Placebo