NCT02620020

A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain

A Randomized, Double-blind, Multi-dose, Placebo-controlled Phase 2/3 Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate to Severe Chronic Low Back Pain

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 563 (actual)
• Sponsor: Regeneron Pharmaceuticals · Industry
• Sex: All
• Age: 35 Years
• Healthy volunteers: Not accepted

Summary

The main objective of the trial is to evaluate the efficacy of fasinumab compared to placebo as measured by the change from baseline in the average daily Low Back Pain Intensity (LBPI) Numerical Rating Scale (NRS). Secondary objectives of the study are to evaluate the efficacy of fasinumab compared to placebo as measured by: * Change from baseline in the Roland Morris disability questionnaire (RMDQ) total score * Change from baseline in the Patient Global Assessment (PGA) of Low Back Pain (LBP) score * Change from baseline in the average daily LBPI NRS score

Conditions

• Low Back Pain

Interventions

Type	Name	Description
DRUG	Fasinumab	Participants received fasinumab SC or IV, Q4W or Q8W.
DRUG	placebo	Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

Timeline

• Start date: 2016-01-26
• Primary completion: 2017-02-03
• Completion: 2017-09-13
• First posted: 2015-12-02
• Last updated: 2020-06-16
• Results posted: 2019-08-01

Locations

74 sites across 7 countries: United States, Canada, Czechia, Denmark, Estonia, Hungary, Poland