A Study of Ixekizumab in bDMARD-Naive Participants With Radiographic Axial Spondyloarthritis
Study I1F-MC-RHBV (RHBV) is a Phase 3, multicenter, randomized, double-blind, active- and placebo-controlled, parallel-group, outpatient study examining the efficacy and safety of 2 treatment regimens of ixekizumab, 80 mg Q2W and 80 mg Q4Wsubcutaneous (SC), as compared to placebo SC in patients with rad-axSpA, during a 16-week
Blinded Treatment Dosing Period. Adalimumab at the approved dose of 40 mg (SC) and the approved regimen of Q2W has been selected as the active control for comparison with placebo to provide the study with internal evidence of assay sensitivity (i.e., generate data on an approved and well characterized anti-TNF treatment and ixekizumab
treatment concurrently in one trial setting rather than comparing with historically observed data with adalimumab).
Study phase: III
Basic eligibility criteria:
Please contact the study coordinator for additional eligibility information.
Patients are eligible to be included in the study if they have an established diagnosis of rad-axSpA with sacroiliitis and have
active disease defined as BASDAI ?4 and back pain ?4 on a numeric rating scale (NRS). Patients must have had an inadequate response to 2 or more nonsteroidal anti-inflammatory drugs (NSAIDs) at the therapeutic dose range (for a total duration of at least 4 weeks) and a history of prior rad-axSpA therapy for at least 3 months. Only bDMARD-naive patients can be enrolled.
Primary disease category: Arthritis
Sponsor: Eli Lilly
Protocol number: I1F-MC-RHBV
Projected enrollment dates: May 2016 to November 2017
Official study title: A Multicenter, Randomized, Double-Blind, Active and Placebo-Controlled 16-Week Study Followed by Long-Term Evaluation of Efficacy and Safety of Ixekizumab (LY2439821) in bDMARD-Naive Patients with Radiographic Axial Spondyloarthritis