Evaluate the Efficacy and Safety of Fasinumab in Patients With Moderate-to-Severe Chronic Low Back Pain and Osteoarthritis of the Hip or Knee

NCT03285646 | Terminated Phase 3 Results DMC FDA Drug

• 2 other identifiers: R475-PN-16122017-001943-12
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 56

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.

Conditions

Chronic Low Back Pain; Osteoarthritis

Keywords

Knee; Hip

Outcome Measures

Primary Outcomes (1)

• Change From Baseline to Week 16 in the Average Daily Low Back Pain Intensity (LBPI) Numeric Rating Scale (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.

  Week 1, Week 2, Week 4, Week 8, Week 12, Week 16

Secondary Outcomes (13)

• Change From Baseline to Week 16 in the Roland Morris Disability Questionnaire (RMDQ) Total Score

  Week 2, Week 4, Week 8, Week 12, Week 16

• Change From Baseline to Week 16 in Patient Global Assessment (PGA) of Low Back Pain (LBP) Score

  Week 2, Week 4, Week 8, Week 12, Week 16

• Number of Participants Achieving ≥30% Reduction From Baseline to Week 16 in Average Daily LBPI NRS Score

  Week 16

• Change From Baseline to Week 16 in the Brief Pain Inventory-Short Form (BPI-sf) Pain Interference Score

  Week 2, Week 4, Week 8, Week 12, Week 16

• Number of Adjudicated Arthropathy (AA) Events

  Up to Week 36

Study Arms (2)

Fasinumab

EXPERIMENTAL

Subcutaneous (SC) every 4 weeks (Q4W)

Drug: Fasinumab

Placebo

EXPERIMENTAL

SC every 4 weeks

Drug: Placebo

Interventions

Fasinumab DRUG

Subcutaneous (SC) every 4 weeks (Q4W)

Also known as: REGN475

Fasinumab

Placebo DRUG

Subcutaneous (SC) every 4 weeks (Q4W)

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Clinical diagnosis of non-radicular moderate-to-severe CLBP for ≥3 months (prior to screening visit)
• 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
• History of inadequate relief of CLBP from non-pharmacologic therapy
• Willing to undergo joint replacement (JR) surgery, if necessary
• History of regular analgesic medication use
• History of inadequate pain relief or intolerance to analgesics used for chronic LBP

You may not qualify if:

• Patient is not a candidate for MRI
• History of major trauma or back surgery in the past 6 months prior to the screening visit
• History or presence of pyriformis syndrome
• Evidence on baseline lumbar spine magnetic resonance imaging of potentially confounding conditions
• History or evidence on joint imaging of conditions that may confound joint safety evaluation
• Evidence or symptoms consistent with autonomic dysfunction (e.g., orthostatic hypotension and/or autonomic symptoms) as defined in the protocol
• Recent use of longer acting pain medications
• Other medical conditions that may interfere with participation or accurate assessments during the trial

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead
• Teva Pharmaceutical Industries, Ltd.: collaborator

Study Sites (56)

Regeneron Research Site

Phoenix, Arizona, 85053, United States

Location

Regeneron Research Site

Tucson, Arizona, 85704, United States

Location

Regeneron Research Site

Tucson, Arizona, 85712, United States

Location

Regeneron Research Site

Anaheim, California, 92801, United States

Location

Regeneron Research Site

Anaheim, California, 92805, United States

Location

Regeneron Research Site

La Mesa, California, 91942, United States

Location

Regeneron Research Site

North Hollywood, California, 91606, United States

Location

Regeneron Research Site

San Diego, California, 92103, United States

Location

Regeneron Research Site

San Marcos, California, 92078, United States

Location

Regeneron Research Site

Santa Ana, California, 92703, United States

Location

Regeneron Research Site

Spring Valley, California, 91978, United States

Location

Regeneron Research Site

Whittier, California, 90602, United States

Location

Regeneron Research Site

Stamford, Connecticut, 06905, United States

Location

Regeneron Research Site

Waterbury, Connecticut, 06708, United States

Location

Regeneron Research Site

Clearwater, Florida, 33756, United States

Location

Regeneron Research Site

Hialeah, Florida, 33012, United States

Location

Regeneron Research Site

Jacksonville, Florida, 32256, United States

Location

Regeneron Research Site

Lauderdale Lakes, Florida, 33319, United States

Location

Regeneron Research Site

Miami, Florida, 33155, United States

Location

Regeneron Research Site

Ocoee, Florida, 34761, United States

Location

Regeneron Research Site

Orlando, Florida, 32801, United States

Location

Regeneron Research Site

Orlando, Florida, 32806, United States

Location

Regeneron Research Site

Port Orange, Florida, 32127, United States

Location

Regeneron Research Site

Sarasota, Florida, 34232, United States

Location

Regeneron Research Site

Atlanta, Georgia, 30189, United States

Location

Regeneron Research Site

Columbus, Georgia, 31904, United States

Location

Regeneron Research Site #1

Marietta, Georgia, 30060, United States

Location

Regeneron Research Site #2

Marietta, Georgia, 30060, United States

Location

Regeneron Research Site

Newnan, Georgia, 30265, United States

Location

Regeneron Research Site

Idaho Falls, Idaho, 83404, United States

Location

Regeneron Research Site

Chicago, Illinois, 60602, United States

Location

Regeneron Research Site

Chicago, Illinois, 60607, United States

Location

Regeneron Research Site

Valparaiso, Indiana, 46383, United States

Location

Regeneron Research Site

West Des Moines, Iowa, 50265, United States

Location

Regeneron Research Site

Edgewood, Kentucky, 41017, United States

Location

Regeneron Research Site

New Orleans, Louisiana, 70115, United States

Location

Regeneron Research Site

Bay City, Michigan, 48706, United States

Location

Regeneron Research Site

St Louis, Missouri, 63117, United States

Location

Regeneron Research Site

Lincoln, Nebraska, 68516, United States

Location

Regeneron Research Site

Las Vegas, Nevada, 89144, United States

Location

Regeneron Research Site

Berlin, New Jersey, 08009, United States

Location

Regeneron Research Site

Albuquerque, New Mexico, 87102, United States

Location

Regeneron Research Site

Hartsdale, New York, 10530, United States

Location

Regeneron Research Site

New York, New York, 10036, United States

Location

Regeneron Research Site

High Point, North Carolina, 27262, United States

Location

Regeneron Research Site

Fargo, North Dakota, 58105, United States

Location

Regeneron Research Site

Beavercreek, Ohio, 45431, United States

Location

Regeneron Research Site

Oklahoma City, Oklahoma, 73103, United States

Location

Regeneron Research Site

Duncansville, Pennsylvania, 16635, United States

Location

Regeneron Research Site

Rapid City, South Dakota, 57702, United States

Location

Regeneron Research Site #1

Memphis, Tennessee, 38119, United States

Location

Regeneron Research Site #2

Memphis, Tennessee, 38119, United States

Location

Regeneron Research Site

Houston, Texas, 77058, United States

Location

Regeneron Research Site

Katy, Texas, 77498, United States

Location

Regeneron Research Site

Plano, Texas, 75075, United States

Location

Regeneron Research Site

Kenosha, Wisconsin, 53144, United States

Location

MeSH Terms

Conditions

Osteoarthritis

Interventions

fasinumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Limitations and Caveats

Enrollment and study drug administration was stopped due to an urgent safety measure. As a result the small number of participants enrolled in this study limited the interpretability of the efficacy results.

Results Point of Contact

• Title: Study Director
• Organization: Regeneron Pharmaceuticals, Inc.

clinicaltrials@regeneron.com

844-734-6643

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 14, 2017
• First Posted: September 18, 2017
• Study Start: October 30, 2017
• Primary Completion: May 5, 2018
• Study Completion: May 2, 2019
• Last Updated: June 30, 2021
• Results First Posted: June 30, 2021

Record last verified: 2021-06

Locations

US (56)