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 Randomized, Double-Blind, Multi-Dose, Placebo And NSAID Controlled Study To Evaluate The Efficacy And Safety Of Fasinumab In Patients With Pain Due To Osteoarthritis Of The Knee Or Hip

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1,650 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Osteoarthritis, Knee
• Osteoarthritis, Hip

Interventions

Type	Name	Description
DRUG	Fasinumab	Solution for injection in pre-filled syringe
OTHER	Diclofenac	NSAID active comparator (capsule)
OTHER	Celecoxib	NSAID active comparator (capsule)
DRUG	Matching placebo	Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)

Timeline

• Start date: 2017-10-26
• Primary completion: 2019-12-13
• Completion: 2020-11-09
• First posted: 2017-10-09
• Last updated: 2023-02-24
• Results posted: 2023-02-24

Locations

71 sites across 1 country: United States

Regulatory

• FDA-regulated drug study