Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2014-003701-15 | EudraCT Number |
Not provided
Not provided
Not provided
Per Amgen's decision to discontinue co-development and co-commercialization of brodalumab, study is being cancelled/closed.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Brodalumab | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Brodalumab 210 mg | Drug | 210 mg brodalumab will be administered subcutaneously |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of SpondyloArthritis international Society (ASAS) | Achievement of Assessment of SpondyloArthritis international Society (ASAS) 20 response at week 16 | Week 16 |
Not provided
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| MD | Amgen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Scottsdale | Arizona | 85258 | United States | ||
| Research Site |
Not provided
| Label | URL |
|---|---|
| AmgenTrials clinical trials website | View source |
Not provided
Not provided
| ID | Term |
|---|---|
| D000089183 | Axial Spondyloarthritis |
| D013167 | Spondylitis, Ankylosing |
| D000089202 | Non-Radiographic Axial Spondyloarthritis |
| ID | Term |
|---|---|
| D025242 | Spondylarthropathies |
| D025241 | Spondylarthritis |
| D013166 | Spondylitis |
| D013122 | Spinal Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C571216 | brodalumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo |
| Drug |
Placebo will be administered subcutaneously |
|
| 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 |
| D001847 |
| Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D000844 | Ankylosis |
| D007592 | Joint Diseases |
| D001168 | Arthritis |