Clinical trial NCT03285646: Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Chronic Low Back Pain
Osteoarthritis
Keywords: Knee
Hip
Lead sponsor: Regeneron Pharmaceuticals
Sponsor class: INDUSTRY
Collaborators: name: Teva Pharmaceutical Industries, Ltd.
First posted: 2017-09-18
Enrollment: 63
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (NRS) Score
timeFrame: Week 1, Week 2, Week 4, Week 8, Week 12, Week 16
Secondary outcomes:
measure: Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16
measure: Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16
measure: Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score
timeFrame: Week 16
measure: Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score
timeFrame: Week 2, Week 4, Week 8, Week 12, Week 16
measure: Number of Adjudicated Arthropathy (AA) Events
timeFrame: Up to Week 36
measure: Number of Adjudicated Arthropathy (AA) Events Meeting Destructive Arthropathy (DA) Criteria
timeFrame: Up to Week 36
measure: Number of Treatment-Emergent Adverse Events (TEAEs)
timeFrame: Up to Week 16
measure: Number of Sympathetic Nervous System (SNS) Dysfunction Events
timeFrame: Up to Week 36
measure: Number of Peripheral Sensory Adverse Events (AEs) That Require a Neurology Consultation
timeFrame: Up to Week 36
measure: Number of All-Cause Joint Replacement (JR) Surgery Events
timeFrame: Up to Week 36
measure: Number of Joint Replacement (JR) Surgery Events Reported at Telephone Survey After Last Dose of Study Drug
timeFrame: Up to Week 64
measure: Number of Participants With at Least One Positive Anti-Drug Antibody (ADA) Assay
timeFrame: 16 Weeks
measure: Serum Concentration of Functional Fasinumab Over Time
timeFrame: Baseline, Week 2, Week 4, Week 8, Week 16
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Regeneron Research Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Research Site
state: Arizona
city: Tucson
country: United States
facility: Regeneron Research Site
state: Arizona
city: Anaheim
country: United States
facility: Regeneron Research Site
state: California
city: Anaheim
country: United States
facility: Regeneron Research Site
state: California
city: La Mesa
country: United States
facility: Regeneron Research Site
state: California
city: North Hollywood
country: United States
facility: Regeneron Research Site
state: California
city: San Diego
country: United States
facility: Regeneron Research Site
state: California
city: San Marcos
country: United States
facility: Regeneron Research Site
state: California
city: Santa Ana
country: United States
facility: Regeneron Research Site
state: California
city: Spring Valley
country: United States
facility: Regeneron Research Site
state: California
city: Whittier
country: United States
facility: Regeneron Research Site
state: California
city: Stamford
country: United States
facility: Regeneron Research Site
state: Connecticut
city: Waterbury
country: United States
facility: Regeneron Research Site
state: Connecticut
city: Clearwater
country: United States
facility: Regeneron Research Site
state: Florida
city: Hialeah
country: United States
facility: Regeneron Research Site
state: Florida
city: Jacksonville
country: United States
facility: Regeneron Research Site
state: Florida
city: Lauderdale Lakes
country: United States
facility: Regeneron Research Site
state: Florida
city: Miami
country: United States
facility: Regeneron Research Site
state: Florida
city: Ocoee
country: United States
facility: Regeneron Research Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Research Site
state: Florida
city: Orlando
country: United States
facility: Regeneron Research Site
state: Florida
city: Port Orange
country: United States
facility: Regeneron Research Site
state: Florida
city: Sarasota
country: United States
facility: Regeneron Research Site
state: Florida
city: Atlanta
country: United States
facility: Regeneron Research Site
state: Georgia
city: Columbus
country: United States
facility: Regeneron Research Site
state: Georgia
city: Marietta
country: United States
facility: Regeneron Research Site #1
state: Georgia
city: Marietta
country: United States
facility: Regeneron Research Site #2
state: Georgia
city: Newnan
country: United States
facility: Regeneron Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Regeneron Research Site
state: Idaho
city: Chicago
country: United States
facility: Regeneron Research Site
state: Illinois
city: Chicago
country: United States
facility: Regeneron Research Site
state: Illinois
city: Valparaiso
country: United States
facility: Regeneron Research Site
state: Indiana
city: West Des Moines
country: United States
facility: Regeneron Research Site
state: Iowa
city: Edgewood
country: United States
facility: Regeneron Research Site
state: Kentucky
city: New Orleans
country: United States
facility: Regeneron Research Site
state: Louisiana
city: Bay City
country: United States
facility: Regeneron Research Site
state: Michigan
city: Saint Louis
country: United States
facility: Regeneron Research Site
state: Missouri
city: Lincoln
country: United States
facility: Regeneron Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Regeneron Research Site
state: Nevada
city: Berlin
country: United States
facility: Regeneron Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Regeneron Research Site
state: New Mexico
city: Hartsdale
country: United States
facility: Regeneron Research Site
state: New York
city: New York
country: United States
facility: Regeneron Research Site
state: New York
city: High Point
country: United States
facility: Regeneron Research Site
state: North Carolina
city: Fargo
country: United States
facility: Regeneron Research Site
state: North Dakota
city: Beavercreek
country: United States
facility: Regeneron Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Regeneron Research Site
state: Oklahoma
city: Duncansville
country: United States
facility: Regeneron Research Site
state: Pennsylvania
city: Rapid City
country: United States
facility: Regeneron Research Site
state: South Dakota
city: Memphis
country: United States
facility: Regeneron Research Site #1
state: Tennessee
city: Memphis
country: United States
facility: Regeneron Research Site #2
state: Tennessee
city: Houston
country: United States
facility: Regeneron Research Site
state: Texas
city: Katy
country: United States
facility: Regeneron Research Site
state: Texas
city: Plano
country: United States
facility: Regeneron Research Site
state: Texas
city: Kenosha
country: United States
facility: Regeneron Research Site
state: Wisconsin
Study officials:
affiliation: Regeneron Pharmaceuticals
name: Clinical Trial Management
role: STUDY_DIRECTOR
References: