Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis

Amgen

Status and phase

Withdrawn

Phase 2

Conditions

Axial Spondyloarthritis

Treatments

Drug: Placebo

Drug: Brodalumab 210 mg

Study type

Interventional

Funder types

Industry

Identifiers

NCT02429882

20101228

2014-003701-15 (EudraCT Number)

Details and patient eligibility

About

The purpose of this study is to assess the safety and efficacy of brodalumab compared with placebo in participants with axial spondyloarthritis. Subjects will be randomized in a 1:1 ratio to brodalumab or placebo for the first part of the study. Subjects will then receive open label brodalumab for the remainder of the study. The entire study will be 312 weeks in duration for each subject.

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject fulfills the ASAS classification criteria of axial spondyloarthritis (except Crohn's disease criterion) for > 3 months with age of onset < 45 years of age
Subject has Bath Ankylosing Spondylitis DIsease Activity Index (BASDAI) score greater than or equal to 4 at screening and baseline
Subject has spinal pain score (BASDAI question #2) greater than or equal to 4 at screening and baseline
Subject has had adequate therapeutic trial (at least 4 weeks) of greater than or equal to 2 non-steroidal anti-inflammatory drgs (NSAIDs) at the maximum recommended dose unless contraindicated or subject is intolerant
For subjects receiving non-biologic DMARDS subject has received treatment for greater than or equal to 3 months with a stable doe for greater than or equal to 4 weeks prior to initiation of IM
For subjects receiving oral corticosteroids: the subject must be on a stable dose (not to exceed the equivalent of 10 mg of prednisone per day) for equal to or greater than 4 weeks prior to initiation of IMP

Exclusion criteria

Complete ankylosis (fusion) of the spine; Subject has a positive test for tuberculosis
Subject has a planned surgical intervention between baeline and week 16
Subject has an active infection or history of infections as follows (any active infection for which systemic anti-infectives were used within 28 day prior to the first MP dose
A serious infection, defined as requiring hospitalization or intravenous anti-infectives within 8 weeks prior to the first IMP dose
Recurrent or chronic infections or other active infection that, in the opinion ofthe investigator might cause this study to be detrimental to the subject)
Subject has active Crohn's disease or a history of Crohn's disease
Subject has active ulcerative colitis requiring daily use of immunosuppressive therapy
Subject has had active fibromyalgia within the past 12 months
Subject has a prior history of greater than 1 anti-TNF therapy for ankylosing spondylitis
Subject has used commercially available or investigational biologic therapies for ankylosing spondylitis as follows
- Anti-tumor necrosis factor (TNF) therapy as follows: within 1 month prior to IMP initiation for etanercept and within 2 months prior to IMP initiation for other anti-TNF agents.
- Other experimental or commercially available biologic therapies for ankylosing spondylitis within 3 months prior to IMP initiation
- Anti-IL17 biologics (eg, brodalumab, secukinumab, ixekizumab) or anti-IL12/IL23 biologic therapy (eg, ustekinumab, briakinumab) at any time
- Rituximab at any time