CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 563 enrolled
Drug / intervention
Fasinumab +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02620020
NCT02620020Phase 3Completed
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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

Regeneron Pharmaceuticals·interventional·Posted Dec 2, 2015·Updated Jun 16, 2020

In Brief

A Phase 3 clinical trial evaluating Fasinumab and placebo for Low Back Pain. Completed, enrolled 563 participants across 74 sites in 7 countries.

Detailed 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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
CountriesCanada, Czechia, Denmark, Estonia, Hungary, Poland, United States
Collaborators--

Timeline

Phase 3CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2, 2015
Enrollment StartJan 26, 2016
Primary CompletionFeb 3, 2017
Study CompletionSep 13, 2017
TodayJul 2, 2026
Enrollment to primary: 1.0 yearsPosted 10.6 years ago

Interventions

Fasinumabdrug

Participants received fasinumab SC or IV, Q4W or Q8W.

placebodrug

Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.