NCT03285646

Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 63 (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 in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Conditions

• Chronic Low Back Pain
• Osteoarthritis

Interventions

Type	Name	Description
DRUG	Fasinumab	Subcutaneous (SC) every 4 weeks (Q4W)
DRUG	Placebo	Subcutaneous (SC) every 4 weeks (Q4W)

Timeline

• Start date: 2017-10-30
• Primary completion: 2018-05-05
• Completion: 2019-05-02
• First posted: 2017-09-18
• Last updated: 2021-06-30
• Results posted: 2021-06-30

Locations

56 sites across 1 country: United States

Regulatory

• FDA-regulated drug study