A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)

Kyowa Kirin

Status and phase

Completed

Phase 3

Conditions

Axial Spondyloarthritis

Treatments

Drug: Brodalumab

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT02985983

4827-006

Details and patient eligibility

About

To evaluate the efficacy of Brodalumab in axSpA (ankylosing spondylitis [AS] and non-radiographic axial spondyloarthritis [nr-axSpA]) subjects compared to placebo, as measured by the proportion of axSpA subjects achieving an Assessment of SpondyloArthritis international Society (ASAS) 40 response at week 16.

Enrollment

159 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject with age at onset <45 years and continuous chronic back pain for ≥ 3 months fulfills the ASAS classification criteria of axial spondyloarthritis (with the exception of the Crohn's disease)
Subject has Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at screening and enrollment
Subject has spinal pain score (BASDAI question #2) ≥ 4 at screening and enrollment
Subject has had adequate therapy with non-steroidal anti-inflammatory drugs (oral NSAIDs) for back pain for at least 3 months with inadequate treatment response before enrollment

Exclusion criteria

Complete ankylosis (fusion) of the spine
Subject with active ongoing inflammatory diseases other than axSpA that might confound the evaluation of Brodalumab therapy, including reactive arthritis, spondyloarthritis associated with inflammatory bowel disease, SAPHO syndrome (pustulotic arthro-osteitis), fibromyalgia, ankylosing spinal hyperostosis, osteitis condensans ilii, spondylosis deformans, or osteoarthritis sacroiliac joint disease
Subject has a prior history of >1 anti-tumor necrosis factor (TNF) therapy
Subject has a history or evidence of suicidal ideation (severity of 4 or 5) or any suicidal behavior based on an assessment with the Columbia-Suicide Severity Rating Scale (C-SSRS) at enrollment
Subject has a history or evidence of a psychiatric disorder, alcohol and/or substance abuse
Subject has severe depression based on a total score of ≥ 15 on the Patient Health Questionnaire-8 (PHQ-8) at enrollment (note: subjects with a total score of 10 to 14 on the PHQ-8 should be referred to a mental health care professional)