drugset / Trial / NCT03304379
Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip
Phase 3
Completed
1650 enrolled
Regeneron Pharmaceuticals
Teva Pharmaceutical Industries, Ltd. · collab
RandomizedParallel-groupTriple-blindTreatment
Summary
The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: * To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip * To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
Timeline
- Start
- 2017-10-26
- Primary completion
- 2019-12-13
- Completion
- 2020-11-09
Publications
- DiMartino SJ, Gao H, Eng S, Valenzuela G, Fuerst T, Emeremni C, Ho T, Hassan HE, Turner KC, Davis JD, Zaim S, Chao J, Patel Y, Brener L, Trinh N, Manvelian G, Fetell M, Braunstein N, Geba GP, Dakin P. Efficacy and safety of fasinumab in an NSAID-controlled study in patients with pain due to osteoarthritis of the knee or hip. BMC Musculoskelet Disord. 2025 Feb 25;26(1):192. doi: 10.1186/s12891-025-08402-8.
- DiMartino SJ, Gao H, Neogi T, Fuerst T, Zaim S, Eng S, Ho T, Manvelian G, Braunstein N, Geba GP, Dakin P. Prevalence of preexisting articular bone pathology in patients with osteoarthritis screened for fasinumab clinical trials identified by X-ray or magnetic resonance imaging. Osteoarthritis Cartilage. 2024 Dec;32(12):1601-1609. doi: 10.1016/j.joca.2024.07.001. Epub 2024 Jul 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fasinumab | Monoclonal antibody | 1 mg | — |