NCT03956550

A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 259 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 40 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis of the Knee
• Pain

Interventions

Type	Name	Description
DRUG	REGN5069	Intravenous (IV) Dose every 4 weeks (Q4W)
DRUG	Matching Placebo	Intravenous (IV) Dose every 4 weeks (QW4)

Timeline

• Start date: 2019-05-21
• Primary completion: 2020-05-01
• Completion: 2020-10-29
• First posted: 2019-05-20
• Last updated: 2021-07-01
• Results posted: 2021-07-01

Locations

12 sites across 5 countries: United States, Georgia, Moldova, Poland, Ukraine

Regulatory

• FDA-regulated drug study