Trials / Completed
CompletedNCT02985983
A Study of Brodalumab in Subjects With Axial Spondyloarthritis (axSpA)
A Phase 3 Multicenter, Randomized, Double-blind, Placebo-controlled Study With an Open Label Extension to Evaluate the Efficacy and Safety of Brodalumab in Subjects With Axial Spondyloarthritis
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 159 (actual)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Brodalumab | Administered Brodalumab by subcutaneous (SC) injection until week 66. |
| DRUG | Placebo | Administered Placebo by subcutaneous (SC) injection until week 16. Administered Brodalumab by SC injection from week 17 until week 66. |
Timeline
- Start date
- 2017-03-07
- Primary completion
- 2019-09-23
- Completion
- 2019-09-23
- First posted
- 2016-12-07
- Last updated
- 2024-07-16
Locations
48 sites across 3 countries: Japan, South Korea, Taiwan
Source: ClinicalTrials.gov record NCT02985983. Inclusion in this directory is not an endorsement.