A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Summary
The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy. The secondary objectives of the study are: * To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks * To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks * To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations
Timeline
- Start
- 2019-05-21
- Primary completion
- 2020-05-01
- Completion
- 2020-10-29
Outcome
Missed primary endpoint
Stopped: “Regeneron has discontinued further clinical development of REGN5069, an antibody to GFRα3, which was previously being studied in osteoarthritis pain of the knee”
registry analysis (superiority test); Placebo vs REGN5069 100 mg Q4W; p = 0.2978; Mixed Models Analysis NCT03956550 ↗
registry analysis (superiority test); Placebo vs REGN5069 1000 mg Q4W; p = 0.6890; Mixed Models Analysis NCT03956550 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | NADECNEMAB | Monoclonal antibody | — | Intravenous |