Clinical trial NCT02620020: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Low Back Pain
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2015-12-02
Enrollment: 563
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Change From Baseline to Week 16 in the Average Daily Low Back Pain Index Numeric Rating Scale (LBPI NRS) Score
timeFrame: Baseline to Week 16
Secondary outcomes:
measure: Change From Baseline to Weeks 2, 4, 8, and 12 in the Average Low Back Pain Index Numeric Rating Scale Score (LBPI NRS)
timeFrame: Baseline to Weeks 2, 4, 8, and 12
measure: Change From Baseline to Week 16 in Roland Morris Disability Questionnaire (RMDQ) Total Score
timeFrame: Baseline to Week 16
measure: Change From Baseline to Week 16 in the Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
timeFrame: Baseline to Week 16
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Chandler
country: United States
state: Arizona
city: Glendale
country: United States
state: Arizona
city: Mesa
country: United States
state: Arizona
city: Phoenix
country: United States
state: Arizona
city: Scottsdale
country: United States
state: Arizona
city: Tucson
country: United States
state: Arizona
city: Little Rock
country: United States
state: Arkansas
city: Beverly Hills
country: United States
state: California
city: Carlsbad
country: United States
state: California
city: Lakewood
country: United States
state: California
city: Long Beach
country: United States
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: Santa Rosa
country: United States
state: California
city: Vista
country: United States
state: California
city: Aurora
country: United States
state: Colorado
city: Colorado Springs
country: United States
state: Colorado
city: Littleton
country: United States
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Clearwater
country: United States
state: Florida
city: Fort Myers
country: United States
state: Florida
city: Leesburg
country: United States
state: Florida
city: Miami
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Evansville
country: United States
state: Indiana
city: Council Bluffs
country: United States
state: Iowa
city: Worcester
country: United States
state: Massachusetts
city: Edina
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Saint Louis
country: United States
state: Missouri
city: Elkhorn
country: United States
state: Nebraska
city: Henderson
country: United States
state: Nevada
city: Las Vegas
country: United States
state: Nevada
city: Jamaica
country: United States
state: New York
city: New York
country: United States
state: New York
city: Williamsville
country: United States
state: New York
city: Cary
country: United States
state: North Carolina
city: High Point
country: United States
state: North Carolina
city: Raleigh
country: United States
state: North Carolina
city: Salisbury
country: United States
state: North Carolina
city: Wilmington
country: United States
state: North Carolina
city: Akron
country: United States
state: Ohio
city: Cincinnati
country: United States
state: Ohio
city: Columbus
country: United States
state: Ohio
city: Oklahoma City
country: United States
state: Oklahoma
city: Duncansville
country: United States
state: Pennsylvania
city: Anderson
country: United States
state: South Carolina
city: Greer
country: United States
state: South Carolina
city: Bristol
country: United States
state: Tennessee
city: Knoxville
country: United States
state: Tennessee
city: Cypress
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Lubbock
country: United States
state: Texas
city: Plano
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: London
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
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
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: