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

• Status: Completed
• Trial end date: 2018-10-17
• 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 biological disease-modifying anti-rheumatic drugs (bDMARDs)-naive participants with radiographic axial spondyloarthritis (rad-axSpA).

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

Details

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

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.