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

• Status: Completed
• Trial end date: 2017-09-13
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Regeneron Pharmaceuticals
• Treatments: Fasinumab

Criteria

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