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

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

Outcome

Met primary endpoint

paper At Week 24, greater improvements were observed for fasinumab versus placebo; least-squares mean difference: -0.63 (p = 0.0003) for WOMAC pain PMID 40001000 ↗

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

Indications