Clinical Trials Directory

Trials / Completed

CompletedNCT02683239

Long-Term Safety and Efficacy Study of Fasinumab in Patients With Pain Due to Osteoarthritis (OA) of the Knee or Hip

A Phase 3 Randomized, Double-blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Long-Term Safety and the Efficacy of Fasinumab in Patients With Pain Due to Osteoarthritis of the Knee or Hip

Status
Completed
Phase
Phase 3
Study type
Interventional
Enrollment
5,331 (actual)
Sponsor
Regeneron Pharmaceuticals · Industry
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

Summary

The primary objective of the study is to describe the safety and tolerability of fasinumab, including adverse events of special interest (AESIs), in patients with pain due to radiographically-confirmed OA of the knee or hip.

Conditions

Interventions

TypeNameDescription
DRUGFasinumabParticipants will receive sub-cutaneous (SC) injections of fasinumab
DRUGPlaceboParticipants will receive sub-cutaneous (SC) injections of matching placebo

Timeline

Start date
2016-02-17
Primary completion
2020-12-01
Completion
2021-06-15
First posted
2016-02-17
Last updated
2023-10-13
Results posted
2023-10-13

Locations

149 sites across 21 countries: United States, Bulgaria, Chile, Colombia, Denmark, Estonia, Germany, Hong Kong, Hungary, Italy, Lithuania, Mexico, Peru, Poland, Romania, Russia, South Africa, Spain, Sweden, Ukraine, United Kingdom

Source: ClinicalTrials.gov record NCT02683239. Inclusion in this directory is not an endorsement.