Back to resultsA Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Fasinumab
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain
Eligibility Criteria
Key Inclusion Criteria:
- 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
Key Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Fasinumab 6 mg SC Q4W and Placebo IV Q8W
Fasinumab 9 mg SC Q4W and Placebo IV Q8W
Fasinumab 9 mg IV Q8W and Placebo SC Q4W
Placebo SC Q4W and Placebo IV Q8W
Arm Description
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.
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.
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.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)
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
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
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.
Full Information
NCT ID
NCT02620020
First Posted
November 30, 2015
Last Updated
June 8, 2020
Sponsor
Regeneron Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT02620020
Brief Title
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
Official Title
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
Interventional
2. Study Status
Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
January 26, 2016 (Actual)
Primary Completion Date
February 3, 2017 (Actual)
Study Completion Date
September 13, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
563 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fasinumab 6 mg SC Q4W and Placebo IV Q8W
Arm Type
Experimental
Arm Description
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.
Arm Title
Fasinumab 9 mg SC Q4W and Placebo IV Q8W
Arm Type
Experimental
Arm Description
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.
Arm Title
Fasinumab 9 mg IV Q8W and Placebo SC Q4W
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo SC Q4W and Placebo IV Q8W
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Fasinumab
Other Intervention Name(s)
REGN475
Intervention Description
Participants received fasinumab SC or IV, Q4W or Q8W.
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
Primary Outcome Measure Information:
Title
Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score
Description
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.
Time Frame
Baseline to Week 16
Secondary Outcome Measure Information:
Title
Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)
Description
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.
Time Frame
Baseline to Weeks 2, 4, 8, and 12
Title
Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score
Description
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.
Time Frame
Baseline to Week 16
Title
Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
Description
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.
Time Frame
Baseline to Week 16
10. Eligibility
Sex
All
Minimum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria:
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
Key Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Chandler
State/Province
Arizona
Country
United States
City
Glendale
State/Province
Arizona
Country
United States
City
Mesa
State/Province
Arizona
Country
United States
City
Phoenix
State/Province
Arizona
Country
United States
City
Scottsdale
State/Province
Arizona
Country
United States
City
Tucson
State/Province
Arizona
Country
United States
City
Little Rock
State/Province
Arkansas
Country
United States
City
Beverly Hills
State/Province
California
Country
United States
City
Carlsbad
State/Province
California
Country
United States
City
Lakewood
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Sacramento
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
Santa Rosa
State/Province
California
Country
United States
City
Vista
State/Province
California
Country
United States
City
Aurora
State/Province
Colorado
Country
United States
City
Colorado Springs
State/Province
Colorado
Country
United States
City
Littleton
State/Province
Colorado
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Clearwater
State/Province
Florida
Country
United States
City
Fort Myers
State/Province
Florida
Country
United States
City
Leesburg
State/Province
Florida
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Orlando
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Evansville
State/Province
Indiana
Country
United States
City
Council Bluffs
State/Province
Iowa
Country
United States
City
Worcester
State/Province
Massachusetts
Country
United States
City
Edina
State/Province
Minnesota
Country
United States
City
Kansas City
State/Province
Missouri
Country
United States
City
Saint Louis
State/Province
Missouri
Country
United States
City
Elkhorn
State/Province
Nebraska
Country
United States
City
Henderson
State/Province
Nevada
Country
United States
City
Las Vegas
State/Province
Nevada
Country
United States
City
Jamaica
State/Province
New York
Country
United States
City
New York
State/Province
New York
Country
United States
City
Williamsville
State/Province
New York
Country
United States
City
Cary
State/Province
North Carolina
Country
United States
City
High Point
State/Province
North Carolina
Country
United States
City
Raleigh
State/Province
North Carolina
Country
United States
City
Salisbury
State/Province
North Carolina
Country
United States
City
Wilmington
State/Province
North Carolina
Country
United States
City
Akron
State/Province
Ohio
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
City
Columbus
State/Province
Ohio
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Duncansville
State/Province
Pennsylvania
Country
United States
City
Anderson
State/Province
South Carolina
Country
United States
City
Greer
State/Province
South Carolina
Country
United States
City
Bristol
State/Province
Tennessee
Country
United States
City
Knoxville
State/Province
Tennessee
Country
United States
City
Cypress
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Lubbock
State/Province
Texas
Country
United States
City
Plano
State/Province
Texas
Country
United States
City
San Antonio
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
City
London
State/Province
Ontario
Country
Canada
City
Toronto
State/Province
Ontario
Country
Canada
City
Prague
Country
Czechia
City
Rychnov Nad Kneznou
Country
Czechia
City
Aalborg
Country
Denmark
City
Ballerup
Country
Denmark
City
Tallinn
Country
Estonia
City
Budapest
Country
Hungary
City
Gyula
Country
Hungary
City
Szolnok
Country
Hungary
City
Bialystok
Country
Poland
City
Lodz
Country
Poland
City
Lublin
Country
Poland
City
Rzeszow
Country
Poland
City
Warszawa
Country
Poland
City
Zgierz
Country
Poland
12. IPD Sharing Statement
Learn more about this trial
A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
We'll reach out to this number within 24 hrs