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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
563

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 26, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
February 3, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 13, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 30, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 16, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 8, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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