drugset / Trial / NCT02620020

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

NCT02620020

Phase 2/3 Completed 563 enrolled Regeneron Pharmaceuticals
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2016-01-26
Primary completion
2017-02-03
Completion
2017-09-13

Drugs

EvaluationDrugModalityDoseRoute
Subject Fasinumab Monoclonal antibody 6 mg Subcutaneous
Subject Fasinumab Monoclonal antibody 9 mg Subcutaneous

Indications

No indication recorded.