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

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

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: February 3, 2017

Interventions

  • 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.

Arms, Groups and Cohorts

  • Experimental: Fasinumab 6 mg SC Q4W and Placebo IV Q8W
    • Participants randomized to the fasinumab 6 mg SC Q4W arm received fasinumab 12 mg SC on Day 1 (loading dose) and then 6 mg SC (planned maintenance dose) at Weeks 4, 8, and 12 for a total of 4 doses. Matching placebo was received via intravenous (IV) infusion Q8W on Day 1 and at Week 8.
  • Experimental: Fasinumab 9 mg SC Q4W and Placebo IV Q8W
    • Participants randomized to the fasinumab 9 mg SC Q4W arm received 18 mg SC on day 1 (loading dose) and then 9 mg SC (planned maintenance dose) at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo IV Q8W was received on Day 1 and at Week 8.
  • Experimental: Fasinumab 9 mg IV Q8W and Placebo SC Q4W
    • Participants randomized to the fasinumab 9 mg IV Q8W arm received IV infusions of fasinumab 9 mg on Day 1 and Week 8, for a total of 2 doses. Matching placebo SC Q4W was received on day 1 and at weeks 4, 8, and 12.
  • Experimental: Placebo SC Q4W and Placebo IV Q8W
    • Participants randomized to the matching placebo subcutaneously (SC) every four weeks (Q4W) arm received SC placebo in a manner similar to the SC loading dose of the active groups (placebo loading dose) on Day 1 and then an SC injection of placebo at weeks 4, 8, and 12 for a total of 4 doses. Matching placebo intravenously (IV) every 8 weeks (Q8W) was received on Day 1 and at Week 8.

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • 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
    • 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.
  • Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score
    • Time Frame: Baseline to Week 16
    • 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.
  • Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
    • Time Frame: Baseline to Week 16
    • 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.

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 35 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Regeneron Pharmaceuticals
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Clinical Trial Management, Study Director, Regeneron Pharmaceuticals

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.