A Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Naproxen 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 with placebo, when administered for up to 16 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are: 1. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 2. To evaluate the efficacy of fasinumab compared with placebo, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip 3. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 16 weeks in patients with pain due to OA of the knee or hip 4. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 52 weeks in patients with pain due to OA of the knee or hip 5. To assess the safety and tolerability of fasinumab compared with naproxen, when administered for up to 104 weeks in patients with pain due to OA of the knee or hip 6. To evaluate the pharmacokinetic (PK) profile of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 7. To evaluate the PK profile of fasimumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 8. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 52 weeks 9. To evaluate the immunogenicity of fasinumab administered to patients with pain due to OA of the knee or hip for up to 104 weeks 10. To evaluate the efficacy of fasinumab compared with naproxen, when administered for up to 44 weeks in patients with pain due to OA of the knee or hip
Timeline
- Start
- 2017-08-17
- Primary completion
- 2019-09-09
- Completion
- 2021-08-27
Outcome
Mixed primary results
registry analysis (superiority test); Placebo vs Fasinumab 1 mg SC Q4W; p = 0.0002; Least Squares Mean -0.68 (95% CI -1.028 to -0.324); Mixed Models Analysis NCT03161093 ↗
registry analysis (superiority test); Placebo vs Fasinumab 1 mg SC Q4W; p <0.0001; Least Squares Mean -0.70 (95% CI -1.046 to -0.346); Mixed Models Analysis NCT03161093 ↗
registry analysis (superiority test); Placebo vs Fasinumab 1 mg SC Q8W; p = 0.7036; Least Squares Mean -0.10 (95% CI -0.594 to 0.401); Mixed Models Analysis NCT03161093 ↗
registry analysis (superiority test); Placebo vs Fasinumab 1 mg SC Q8W; p = 0.4605; Least Squares Mean -0.18 (95% CI -0.657 to 0.297); Mixed Models Analysis NCT03161093 ↗
Publications
- DiMartino SJ, Cicirello H, Magyar A, Eng S, Ho T, Manvelian G, Patel Y, Pervin K, Trinh N, Fetell M, Braunstein N, Geba GP, Dakin P. A phase III, randomised, double-blind, multi-dose, placebo- and naproxen-controlled study to evaluate the efficacy and safety of fasinumab in patients with pain due to osteoarthritis of the knee or hip. RMD Open. 2026 Jan 16;12(1):e006436. doi: 10.1136/rmdopen-2025-006436.
- 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 | Subcutaneous |
| Subject | Naproxen | Small molecule | 500 mg | Oral |