A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
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
2 other identifiers
interventional
563
7 countries
74
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 low-back-pain
Started Jan 2016
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 30, 2015
CompletedFirst Posted
Study publicly available on registry
December 2, 2015
CompletedStudy Start
First participant enrolled
January 26, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 3, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 13, 2017
CompletedResults Posted
Study results publicly available
August 1, 2019
CompletedJune 16, 2020
June 1, 2020
1 year
November 30, 2015
May 11, 2019
June 8, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score
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 Outcomes (3)
Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)
Baseline to Weeks 2, 4, 8, and 12
Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score
Baseline to Week 16
Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
Baseline to Week 16
Study Arms (4)
Fasinumab 6 mg SC Q4W and Placebo IV Q8W
EXPERIMENTALParticipants 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.
Fasinumab 9 mg SC Q4W and Placebo IV Q8W
EXPERIMENTALParticipants 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.
Fasinumab 9 mg IV Q8W and Placebo SC Q4W
EXPERIMENTALParticipants 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.
Placebo SC Q4W and Placebo IV Q8W
EXPERIMENTALParticipants 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.
Interventions
Participants received fasinumab SC or IV, Q4W or Q8W.
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
Eligibility Criteria
You may qualify if:
- Male or female ≥35 years of age at the screening visit
- Clinical diagnosis of chronic moderate to severe LBP (nonradiculopathic)for ≥3 months
- History of regular analgesic medication
- History of inadequate pain relief or intolerance to analgesics used for chronic LBP
- Willing to discontinue current pain medication
You may not qualify if:
- History of lumbosacral radiculopathy within the past 2 years
- Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
- Recent use of longer acting pain medications
- Evidence of destructive arthropathy
- Other medical conditions that may interfere with participation or accurate assessments during the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Unknown Facility
Birmingham, Alabama, United States
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Chandler, Arizona, United States
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Glendale, Arizona, United States
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Mesa, Arizona, United States
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Phoenix, Arizona, United States
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Scottsdale, Arizona, United States
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Tucson, Arizona, United States
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Little Rock, Arkansas, United States
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Beverly Hills, California, United States
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Carlsbad, California, United States
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Lakewood, California, United States
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Long Beach, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Rosa, California, United States
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Vista, California, United States
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Aurora, Colorado, United States
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Colorado Springs, Colorado, United States
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Littleton, Colorado, United States
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Washington D.C., District of Columbia, United States
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Clearwater, Florida, United States
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Fort Myers, Florida, United States
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Leesburg, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Chicago, Illinois, United States
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Evansville, Indiana, United States
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Council Bluffs, Iowa, United States
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Worcester, Massachusetts, United States
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Edina, Minnesota, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Elkhorn, Nebraska, United States
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Henderson, Nevada, United States
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Las Vegas, Nevada, United States
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Jamaica, New York, United States
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New York, New York, United States
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Williamsville, New York, United States
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Cary, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Akron, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Duncansville, Pennsylvania, United States
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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Bristol, Tennessee, United States
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Knoxville, Tennessee, United States
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Cypress, Texas, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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Plano, Texas, United States
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San Antonio, Texas, United States
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Salt Lake City, Utah, United States
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London, Ontario, Canada
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Toronto, Ontario, Canada
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Prague, Czechia
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Rychnov nad Kněžnou, Czechia
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Aalborg, Denmark
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Ballerup Municipality, Denmark
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Tallinn, Estonia
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Budapest, Hungary
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Gyula, Hungary
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Szolnok, Hungary
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Bialystok, Poland
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Lodz, Poland
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Lublin, Poland
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Rzeszów, Poland
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Warsaw, Poland
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Zgierz, Poland
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Limitations and Caveats
FDA placed study on partial clinical hold. Sponsor did not amend the protocol and enrollment and dosing were not resumed. However randomized participants completed all remaining study visits/procedures per protocol except for dosing.
Results Point of Contact
- Title
- Clinical Trial Administrator
- Organization
- Regeneron Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 30, 2015
First Posted
December 2, 2015
Study Start
January 26, 2016
Primary Completion
February 3, 2017
Study Completion
September 13, 2017
Last Updated
June 16, 2020
Results First Posted
August 1, 2019
Record last verified: 2020-06