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

Phase 3CompletedNCT02620020

Regeneron Pharmaceuticals563 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

563

Conditions

Low Back Pain

Interventions

Fasinumab

Eligibility

Sex: ALLMin age: 35 Years

Medical Language ↔ Plain English

Key Inclusion Criteria: 1. Male or female ≥35 years of age at the screening visit 2. Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months 3. History of regular analgesic medication 4. History of inadequate pain relief or intolerance to analgesics used for chronic LBP 5. Willing to discontinue current pain medication Key Exclusion Criteria: 1. History of lumbosacral radiculopathy within the past 2 years 2. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions 3. Recent use of longer acting pain medications 4. Evidence of destructive arthropathy 5. Other medical conditions that may interfere with participation or accurate assessments during the trial

Locations (74)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Chandler, Arizona, United States

Unnamed facility

Glendale, Arizona, United States

Unnamed facility

Mesa, Arizona, United States

Unnamed facility

Phoenix, Arizona, United States

Unnamed facility

Outcomes

Primary Outcomes

Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score

Average daily low back pain (LBP) was assessed on an 11-point numeric rating scale (NRS) and was defined as the average of the non-missing daily LBPI NRS scores for the 7 days before and including nominal visit. Participants described their average low back pain during the past 24 hours on a scale ranging from 0 (no pain) to 10 (worst possible pain), where higher scores indicate higher pain.

Time frame: Baseline to Week 16

Secondary Outcomes

Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)

Time frame: Baseline to Weeks 2, 4, 8, and 12

Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score

The RMDQ is a self-administered, widely used health status measure for lower back pain (LBP). It measures pain and function, using 24 items describing limitations to everyday life that can be caused by LBP. The score of the RMDQ is the total number of items checked - that is from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores indicative of better function.

Time frame: Baseline to Week 16

Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score

The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 0-5 where 1=very well; 2=well; 3=fair; 4=poor; and 5=very poor.

Time frame: Baseline to Week 16