A Study to Determine the Efficacy and Safety of Fasinumab for the Treatment of Adults With Chronic Low Back Pain
NCT ID: NCT02620020
Last Updated: 2020-06-16
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE2/PHASE3
563 participants
INTERVENTIONAL
2016-01-26
2017-09-13
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Treatment of Pain Associated With Fibromyalgia
NCT02146430
Study to Evaluate the Efficacy and Safety of Lenalidomide in the Treatment of Painful Lumbar Radiculopathy
NCT00120120
Phase 2 Efficacy Trial of Z160 in Lumbosacral Radiculopathy
NCT01655849
A Study of Tanezumab in Adults With Chronic Low Back Pain
NCT00876187
Milnacipran for Lumbosacral Radicular Pain
NCT01777581
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
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.
Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
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.
Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
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.
placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fasinumab
Participants received fasinumab SC or IV, Q4W or Q8W.
placebo
Participants received placebo matching to fasinumab SC or IV, Q4W or Q8W.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
35 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Birmingham, Alabama, United States
Chandler, Arizona, United States
Glendale, Arizona, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Tucson, Arizona, United States
Little Rock, Arkansas, United States
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
Aurora, Colorado, United States
Colorado Springs, Colorado, United States
Littleton, Colorado, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
Fort Myers, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Chicago, Illinois, United States
Evansville, Indiana, United States
Council Bluffs, Iowa, United States
Worcester, Massachusetts, United States
Edina, Minnesota, United States
Kansas City, Missouri, United States
St Louis, Missouri, United States
Elkhorn, Nebraska, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Jamaica, New York, United States
New York, New York, United States
Williamsville, New York, United States
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
Akron, Ohio, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
Anderson, South Carolina, United States
Greer, South Carolina, United States
Bristol, Tennessee, United States
Knoxville, Tennessee, United States
Cypress, Texas, United States
Dallas, Texas, United States
Lubbock, Texas, United States
Plano, Texas, United States
San Antonio, Texas, United States
Salt Lake City, Utah, United States
London, Ontario, Canada
Toronto, Ontario, Canada
Prague, , Czechia
Rychnov nad Kněžnou, , Czechia
Aalborg, , Denmark
Ballerup Municipality, , Denmark
Tallinn, , Estonia
Budapest, , Hungary
Gyula, , Hungary
Szolnok, , Hungary
Bialystok, , Poland
Lodz, , Poland
Lublin, , Poland
Rzeszów, , Poland
Warsaw, , Poland
Zgierz, , Poland
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2015-003782-28
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
R475-PN-1524
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.