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

• Status: Completed
• Trial end date: 2019-05-07
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company
• Treatments: Ixekizumab

Criteria

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.