Study Stopped
Per Amgen's decision to discontinue co-development and co-commercialization of brodalumab, study is being cancelled/closed.
Study of Efficacy and Safety of Brodalumab Compared With Placebo in Subjects With Axial Spondyloarthritis
A Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Safety and Efficacy of Brodalumab in Subjects With Axial Spondyloarthritis
2 other identifiers
interventional
N/A
2 countries
5
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2015
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 24, 2015
CompletedFirst Posted
Study publicly available on registry
April 29, 2015
CompletedStudy Start
First participant enrolled
May 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2015
CompletedJune 19, 2015
June 1, 2015
Same day
April 24, 2015
June 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Assessment of SpondyloArthritis international Society (ASAS)
Achievement of Assessment of SpondyloArthritis international Society (ASAS) 20 response at week 16
Week 16
Study Arms (2)
Brodalumab
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Amgenlead
Study Sites (5)
Research Site
Scottsdale, Arizona, 85258, United States
Research Site
Oklahoma City, Oklahoma, 73103, United States
Research Site
Duncansville, Pennsylvania, 16635, United States
Research Site
Winnipeg, Manitoba, R3A 1M3, Canada
Research Site
Winnipeg, Manitoba, R3N 0K6, Canada
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
MD
Amgen
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 24, 2015
First Posted
April 29, 2015
Study Start
May 1, 2015
Primary Completion
May 1, 2015
Study Completion
May 1, 2015
Last Updated
June 19, 2015
Record last verified: 2015-06