Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee (FACT CLBP 1)

June 9, 2021 updated by: Regeneron Pharmaceuticals

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

The primary objective of the study is to evaluate the efficacy of fasinumab in relieving Chronic low back pain (CLBP) as compared to placebo in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and Osteoarthritis (OA) of the knee or hip when treated for up to 16 weeks. The secondary objectives of the study are: To evaluate the safety and tolerability of fasinumab compared to placebo when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To characterize the concentrations of fasinumab in serum over time when participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip are treated for up to 16 weeks; To evaluate the immunogenicity of fasinumab when treated for up to 16 weeks in participants with a clinical diagnosis of moderate-to-severe non-radicular CLBP and OA of the knee or hip.

Study Overview

Status

Status

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

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.
63

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 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

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85053
        • Regeneron Research Site
      • Tucson, Arizona, United States, 85704
        • Regeneron Research Site
      • Tucson, Arizona, United States, 85712
        • Regeneron Research Site
    • California
      • Anaheim, California, United States, 92801
        • Regeneron Research Site
      • Anaheim, California, United States, 92805
        • Regeneron Research Site
      • La Mesa, California, United States, 91942
        • Regeneron Research Site
      • North Hollywood, California, United States, 91606
        • Regeneron Research Site
      • San Diego, California, United States, 92103
        • Regeneron Research Site
      • San Marcos, California, United States, 92078
        • Regeneron Research Site
      • Santa Ana, California, United States, 92703
        • Regeneron Research Site
      • Spring Valley, California, United States, 91978
        • Regeneron Research Site
      • Whittier, California, United States, 90602
        • Regeneron Research Site
    • Connecticut
      • Stamford, Connecticut, United States, 06905
        • Regeneron Research Site
      • Waterbury, Connecticut, United States, 06708
        • Regeneron Research Site
    • Florida
      • Clearwater, Florida, United States, 33756
        • Regeneron Research Site
      • Hialeah, Florida, United States, 33012
        • Regeneron Research Site
      • Jacksonville, Florida, United States, 32256
        • Regeneron Research Site
      • Lauderdale Lakes, Florida, United States, 33319
        • Regeneron Research Site
      • Miami, Florida, United States, 33155
        • Regeneron Research Site
      • Ocoee, Florida, United States, 34761
        • Regeneron Research Site
      • Orlando, Florida, United States, 32801
        • Regeneron Research Site
      • Orlando, Florida, United States, 32806
        • Regeneron Research Site
      • Port Orange, Florida, United States, 32127
        • Regeneron Research Site
      • Sarasota, Florida, United States, 34232
        • Regeneron Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30189
        • Regeneron Research Site
      • Columbus, Georgia, United States, 31904
        • Regeneron Research Site
      • Marietta, Georgia, United States, 30060
        • Regeneron Research Site #1
      • Marietta, Georgia, United States, 30060
        • Regeneron Research Site #2
      • Newnan, Georgia, United States, 30265
        • Regeneron Research Site
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Regeneron Research Site
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Regeneron Research Site
      • Chicago, Illinois, United States, 60607
        • Regeneron Research Site
    • Indiana
      • Valparaiso, Indiana, United States, 46383
        • Regeneron Research Site
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Regeneron Research Site
    • Kentucky
      • Edgewood, Kentucky, United States, 41017
        • Regeneron Research Site
    • Louisiana
      • New Orleans, Louisiana, United States, 70115
        • Regeneron Research Site
    • Michigan
      • Bay City, Michigan, United States, 48706
        • Regeneron Research Site
    • Missouri
      • Saint Louis, Missouri, United States, 63117
        • Regeneron Research Site
    • Nebraska
      • Lincoln, Nebraska, United States, 68516
        • Regeneron Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89144
        • Regeneron Research Site
    • New Jersey
      • Berlin, New Jersey, United States, 08009
        • Regeneron Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87102
        • Regeneron Research Site
    • New York
      • Hartsdale, New York, United States, 10530
        • Regeneron Research Site
      • New York, New York, United States, 10036
        • Regeneron Research Site
    • North Carolina
      • High Point, North Carolina, United States, 27262
        • Regeneron Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58105
        • Regeneron Research Site
    • Ohio
      • Beavercreek, Ohio, United States, 45431
        • Regeneron Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73103
        • Regeneron Research Site
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Regeneron Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Regeneron Research Site
    • Tennessee
      • Memphis, Tennessee, United States, 38119
        • Regeneron Research Site #1
      • Memphis, Tennessee, United States, 38119
        • Regeneron Research Site #2
    • Texas
      • Houston, Texas, United States, 77058
        • Regeneron Research Site
      • Katy, Texas, United States, 77498
        • Regeneron Research Site
      • Plano, Texas, United States, 75075
        • Regeneron Research Site
    • Wisconsin
      • Kenosha, Wisconsin, United States, 53144
        • Regeneron Research Site

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

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
  2. Clinical diagnosis of OA in at least 1 hip or knee joint based on the American College of Rheumatology Criteria with radiographic evidence of OA (K-L ≥2) at screening
  3. History of inadequate relief of CLBP from non-pharmacologic therapy
  4. Willing to undergo joint replacement (JR) surgery, if necessary
  5. History of regular analgesic medication use
  6. History of inadequate pain relief or intolerance to analgesics used for chronic LBP

Key Exclusion Criteria:

  1. Patient is not a candidate for MRI
  2. History of major trauma or back surgery in the past 6 months prior to the screening visit
  3. History or presence of pyriformis syndrome
  4. Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
  5. History or evidence on joint imaging of conditions that may confound joint safety evaluation
  6. Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
  7. Recent use of longer acting pain medications
  8. Other medical conditions that may interfere with participation or accurate assessments during the trial

Note: Other protocol defined Inclusion/ Exclusion criteria apply.

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
  • 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
Subcutaneous (SC) every 4 weeks (Q4W)
Drug: Fasinumab
Subcutaneous (SC) every 4 weeks (Q4W)
Other Names:
  • REGN475
EXPERIMENTAL: Placebo
SC every 4 weeks
Drug: Placebo
Subcutaneous (SC) every 4 weeks (Q4W)

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 Intensity (LBPI) Numeric Rating Scale (NRS) Score
Time Frame: Week 1, Week 2, Week 4, Week 8, Week 12, 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.
Week 1, Week 2, Week 4, Week 8, Week 12, 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 Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score
Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16
The RMDQ is a self-administered, 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 from a minimum of 0 (no disability) to a maximum of 24 (maximum disability), where lower scores are indicative of better function.
Week 2, Week 4, Week 8, Week 12, Week 16
Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16
The PGA of LBP is a participant assessed 5 point Likert scale of LBP ranging from 1-5 where 1 = very well; 2 = well; 3 = fair; 4 = poor; and 5 = very poor.
Week 2, Week 4, Week 8, Week 12, Week 16
Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score
Time Frame: 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.
Week 16
Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score
Time Frame: Week 2, Week 4, Week 8, Week 12, Week 16
The BPI-sf is a self-administered questionnaire for participants to rate the severity of their pain and the degree to which their pain interferes with common dimensions of feeling and function. With a recall period of 24 hours, the questionnaire contains the front and back body diagrams, the 4 pain severity items and 7 pain interference items rated on 0-10 scale; total interference score ranges from 0-10 (0, does not interfere; 10 completely interferes), and the question about percentage of pain relief by analgesics. The BPI pain interference is typically scored as the mean of the 7 interference items.
Week 2, Week 4, Week 8, Week 12, Week 16
Number of Adjudicated Arthropathy (AA) Events
Time Frame: Up to Week 36
Adjudicated arthropathy (AA) is a composite term that encompasses the following conditions: Rapidly progressive OA type 1 and 2, Subchondral insufficiency fractures, and Primary Osteonecrosis. AAs were also evaluated to determine if they met Destructive Arthropathy criteria.
Up to Week 36
Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria
Time Frame: Up to Week 36
Destructive arthropathy (DA) is a unique clinical form of rapidly destructive arthropathy over and above that seen in the normal progression of OA. DA criteria can be associated with Rapidly Progressive Osteoarthritis type 2, Subchondral Insufficiency fracture, and Primary Osteonecrosis.
Up to Week 36
Number of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Week 16
Treatment-emergent adverse events (TEAEs) are defined as those that are not present at baseline or represent the exacerbation of a pre-existing condition during the on-treatment period.
Up to Week 16
Number of Sympathetic Nervous System (SNS) Dysfunction Events
Time Frame: Up to Week 36
Potential events of sympathetic nervous system (SNS) dysfunction were monitored throughout the study through physical examination, AE reporting, assessment of orthostatic hypotension, and the Survey of Autonomic Symptoms. Sympathetic nervous system dysfunction was diagnosed after consultation with an appropriate specialist, such as a neurologist and/or cardiologist.
Up to Week 36
Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation
Time Frame: Up to Week 36
Any peripheral sensory AE (eg, paraesthesia and hypoaesthesia) that required a neurology consultation.
Up to Week 36
Number of All-Cause Joint Replacement (JR) Surgery Events
Time Frame: Up to Week 36
All joint replacement surgery events regardless of cause.
Up to Week 36
Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug
Time Frame: Up to Week 64
An end of study phone contact was conducted approximately 52 weeks following the last dose of study drug (week 12) to evaluate the number of participants who had undergone or were scheduled for JR surgery.
Up to Week 64
Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay
Time Frame: 16 Weeks
Samples for Anti-Drug Antibody (ADA) evaluation were collected at baseline and at subsequent study visits. ADA variables include ADA status (+ or -) and titer as follows: Total participants negative in the ADA assay at all time points analyzed. Pre-existing immunoreactivity - positive response at baseline with all post-dose results negative, or a positive response at baseline with all post-dose responses less than 9-fold over baseline titer levels. Treatment emergent - post-dose positive result when baseline results were negative. Persistent - A positive result detected in at least 2 consecutive post baseline samples separated by at least a 16-week post baseline period, with no negative results in-between. Indeterminate - A positive result at the last collection time point analyzed only. Transient - Not persistent or indeterminate regardless of any missing samples. Treatment boosted - any post-dose positive result at least 9-fold over the baseline level when baseline is positive.
16 Weeks
Serum Concentration of Functional Fasinumab Over Time
Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16
Summary of mean concentration of functional fasinumab are presented by nominal time point.
Baseline, Week 2, Week 4, Week 8, 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

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Teva Pharmaceutical Industries, Ltd.

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.
October 30, 2017

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.
May 5, 2018

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.
May 2, 2019

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).
September 14, 2017

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.
September 14, 2017

First Posted (ACTUAL)

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.
September 18, 2017

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 30, 2021

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 9, 2021

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, 2021

More Information

Terms related to this study

Keywords

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-1612
  • 2017-001943-12 (EUDRACT_NUMBER)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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