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

June 8, 2020 updated by: Regeneron Pharmaceuticals

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

563

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada
      • Toronto, Ontario, Canada
  • Czechia
      • Prague, Czechia
      • Rychnov Nad Kneznou, Czechia
  • Denmark
      • Aalborg, Denmark
      • Ballerup, Denmark
  • Estonia
      • Tallinn, Estonia
  • Hungary
      • Budapest, Hungary
      • Gyula, Hungary
      • Szolnok, Hungary
  • Poland
      • Bialystok, Poland
      • Lodz, Poland
      • Lublin, Poland
      • Rzeszow, Poland
      • Warszawa, Poland
      • Zgierz, Poland
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Glendale, Arizona, United States
      • Mesa, Arizona, United States
      • Phoenix, Arizona, United States
      • Scottsdale, Arizona, United States
      • Tucson, Arizona, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Beverly Hills, California, United States
      • Carlsbad, California, United States
      • Lakewood, California, United States
      • Long Beach, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • Santa Rosa, California, United States
      • Vista, California, United States
    • Colorado
      • Aurora, Colorado, United States
      • Colorado Springs, Colorado, United States
      • Littleton, Colorado, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Florida
      • Clearwater, Florida, United States
      • Fort Myers, Florida, United States
      • Leesburg, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Evansville, Indiana, United States
    • Iowa
      • Council Bluffs, Iowa, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Minnesota
      • Edina, Minnesota, United States
    • Missouri
      • Kansas City, Missouri, United States
      • Saint Louis, Missouri, United States
    • Nebraska
      • Elkhorn, Nebraska, United States
    • Nevada
      • Henderson, Nevada, United States
      • Las Vegas, Nevada, United States
    • New York
      • Jamaica, New York, United States
      • New York, New York, United States
      • Williamsville, New York, United States
    • North Carolina
      • Cary, North Carolina, United States
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
      • Salisbury, North Carolina, United States
      • Wilmington, North Carolina, United States
    • Ohio
      • Akron, Ohio, United States
      • Cincinnati, Ohio, United States
      • Columbus, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Pennsylvania
      • Duncansville, Pennsylvania, United States
    • South Carolina
      • Anderson, South Carolina, United States
      • Greer, South Carolina, United States
    • Tennessee
      • Bristol, Tennessee, United States
      • Knoxville, Tennessee, United States
    • Texas
      • Cypress, Texas, United States
      • Dallas, Texas, United States
      • Lubbock, Texas, United States
      • Plano, Texas, United States
      • San Antonio, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.
Drug: Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
Other Names:
  • REGN475
Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
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.
Drug: Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
Other Names:
  • REGN475
Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
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.
Drug: Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
Other Names:
  • REGN475
Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
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.
Drug: placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 16

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Weeks 2, 4, 8, and 12
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.
Baseline to Week 16
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.
Baseline to Week 16

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 26, 2016

Primary Completion (Actual)

February 3, 2017

Study Completion (Actual)

September 13, 2017

Study Registration Dates

First Submitted

November 30, 2015

First Submitted That Met QC Criteria

November 30, 2015

First Posted (Estimate)

December 2, 2015

Study Record Updates

Last Update Posted (Actual)

June 16, 2020

Last Update Submitted That Met QC Criteria

June 8, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R475-PN-1524
  • 2015-003782-28 (EudraCT Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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