Study to Determine the Safety and the Efficacy of Fasinumab Compared to Placebo and Nonsteroidal Anti-inflammatory Drugs (NSAIDs) for Treatment of Adults With Pain From Osteoarthritis of the Knee or Hip

NCT03304379 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: R475-OA-16882017-001702-15
• Study Type: interventional
• Target: 1,650
• Locations: 1 country
• Sites: 71

Brief Summary

The primary objective of the study is to evaluate the efficacy of fasinumab compared to placebo, when administered for up to 24 weeks in patients with pain due to osteoarthritis (OA) of the knee or hip. The secondary objectives of the study are:

• To evaluate the efficacy of fasinumab compared to non-steroidal anti-inflammatory drugs (NSAID)s, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip
• To assess the safety and tolerability of fasinumab compared to placebo and compared to NSAIDs, when administered for up to 24 weeks in patients with pain due to OA of the knee or hip

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Outcome Measures

Primary Outcomes (2)

• Change From Baseline in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo

  WOMAC pain subscale was a 5-item questionnaire used to assess the amount of pain experienced due to osteoarthritis in the index joint (knee or hip) in past 48 hours. It was calculated as the mean of the scores from the 5 individual questions scored on a numerical rating scale (NRS) of 0 (no pain) to 10 (higher pain), where higher scores indicated higher pain.

  Baseline up to Week 24

• Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Placebo

  Physical function referred to participant's ability to move around and perform usual activities of daily living. The WOMAC physical function subscale was a 17-item questionnaire used to assess the degree of difficulty experienced due to osteoarthritis in index joint (knee or hip) during past 48 hours. It was calculated as mean of the scores from 17 individual questions scored on a NRS of 0 (minimum difficulty) to 10 (maximum difficulty), where higher scores indicated maximum difficulty.

  Baseline up to Week 24

Secondary Outcomes (16)

• Percentage of Participants With Greater Than or Equal to (≥) 30 Percent (%) Reduction From Baseline up to Week 24 in WOMAC Pain Subscale Score in Participants Treated With Fasinumab Compared to Placebo

  Baseline up to Week 24

• Change From Baseline in Patient Global Assessment (PGA) Score up to Week 24 in Participants Treated With Fasinumab Compared to Placebo

  Baseline up to Week 24

• Change From Baseline in WOMAC Pain Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs

  Baseline up to Week 24

• Change From Baseline in WOMAC Physical Function Subscale Scores up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs

  Baseline up to Week 24

• Change From Baseline in PGA Score up to Week 24 in Participants Treated With Fasinumab Compared to Participants Treated With NSAIDs

  Baseline up to Week 24

Study Arms (4)

Dosing regimen 1

EXPERIMENTAL

Drug: Fasinumab; Drug: Matching placebo

Dosing regimen 2

EXPERIMENTAL

Other: Diclofenac; Drug: Matching placebo

Dosing regimen 3

EXPERIMENTAL

Other: Celecoxib; Drug: Matching placebo

Dosing regimen 4

EXPERIMENTAL

Drug: Matching placebo

Interventions

Fasinumab DRUG

Solution for injection in pre-filled syringe

Also known as: REGN475, MT-5547

Dosing regimen 1

Diclofenac OTHER

NSAID active comparator (capsule)

Also known as: ZORVOLEX

Dosing regimen 2

Celecoxib OTHER

NSAID active comparator (capsule)

Also known as: CELEBREX

Dosing regimen 3

Matching placebo DRUG

Fasinumab-matching placebo (solution for injection in pre-filled syringe); NSAID-matching placebo (capsule)

Dosing regimen 1; Dosing regimen 2; Dosing regimen 3; Dosing regimen 4

Eligibility Criteria

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

You may qualify if:

• A clinical diagnosis of osteoarthritis (OA) of the knee or hip based on the American College of Rheumatology criteria with radiologic evidence of OA (K-L score ≥2 for the index joint) at the screening visit.
• Willing to discontinue current pain medications and to adhere to study requirements for rescue treatments (acetaminophen/paracetamol to be taken as needed with a maximum daily dose of 2500 mg \[countries where 500 mg strength tablets/capsules are available\] or 2600 mg \[countries where 325 mg strength tablets/capsules are available\])
• A history of at least 12 weeks of inadequate pain relief or intolerance to analgesics used for pain due to OA of the knee or hip
• Currently using a stable dose of NSAID
• Willing to discontinue glucosamine sulfate and chondroitin sulfate treatments during the 24 weeks of treatment

You may not qualify if:

• Non-compliance with the numeric rating scale (NRS) recording during the pre-randomization period
• History or presence at the screening visit of non-OA inflammatory joint disease, Paget's disease of the spine, pelvis or femur, neuropathic disorders, multiple sclerosis, fibromyalgia, tumors or infections of the spinal cord, or renal osteodystrophy
• History or presence on imaging of arthropathy, hip or knee dislocation, extensive subchondral cysts, evidence of severe structural damage, bone collapse, or primary metastatic tumor with the exception of chondromas or pathologic fractures
• Trauma to the index joint within 3 months prior to the screening visit
• Signs or symptoms of carpal tunnel syndrome within 6 months of screening
• Patient is not a candidate for magnetic resonance imaging (MRI)
• Is scheduled for a JR surgery to be performed during the study period or who would be unwilling or unable to undergo JR surgery if needed
• History or presence at the screening visit of autonomic or diabetic neuropathy, or other peripheral neuropathy, including reflex sympathetic dystrophy
• Evidence of autonomic neuropathy as defined in the schedule of assessments (SoAs)
• History or diagnosis of chronic autonomic failure syndrome including pure autonomic failure, multiple system atrophy
• Use of systemic corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit
• Exposure to an anti-NGF antibody prior to the screening visit or known sensitivity or intolerance to anti-NGF antibodies
• Women of childbearing potential who are unwilling to practice highly effective contraception prior to the start of the first treatment, during the study, and for at least 20 weeks after the last dose

Sponsors & Collaborators

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

Study Sites (71)

Pinnacle Research Group, Llc

Anniston, Alabama, 36207, United States

Location

Horizon Research Partners

Mobile, Alabama, 36608, United States

Location

Clinical Research Advantage, Inc./Warner Family Practice, PC

Chandler, Arizona, 85224, United States

Location

Synexus Central Phoenix Medical Clinic

Phoenix, Arizona, 85020, United States

Location

Clinical Research Consortium Arizona

Tempe, Arizona, 85283, United States

Location

Advance Research Center

Anaheim, California, 92805, United States

Location

TriWest Research Associates, LLC

El Cajon, California, 92020, United States

Location

Paragon Rx Clinical Research, Inc.

Garden Grove, California, 92840, United States

Location

Catalina Research Institute, LLC

Montclair, California, 91763, United States

Location

Sierra Clinical Research

Roseville, California, 95661, United States

Location

UC Davis Center for Musculoskeletal Health

Sacramento, California, 95817, United States

Location

Advanced Research Center, Inc

San Diego, California, 92103, United States

Location

California Research Foundation

San Diego, California, 92123, United States

Location

Paragon Rx Clinical Research, Inc

Santa Ana, California, 92703, United States

Location

Encompass Clinical Research

Spring Valley, California, 91978, United States

Location

Westlake Medical Research

Thousand Oaks, California, 91360, United States

Location

Synexus Clinical Research US, Inc.

Vista, California, 92083, United States

Location

Mountain View Clinical Research

Denver, Colorado, 80209, United States

Location

New England Research Associates, LLC

Bridgeport, Connecticut, 06606, United States

Location

CRM of Greater New Haven, LLC

Hamden, Connecticut, 06157, United States

Location

Stamford Therapeutics Consortium

Stamford, Connecticut, 06905, United States

Location

Avail Clinical Research, LLC

DeLand, Florida, 32720, United States

Location

AMB Research Center, Inc

Miami, Florida, 33144, United States

Location

Allied Biomedical Research Institute

Miami, Florida, 33155, United States

Location

Lakes Research, LLC

Miami Lakes, Florida, 33014, United States

Location

Bioclinica Research

Orlando, Florida, 32806, United States

Location

Gulf Region Clinical Research institute

Pensacola, Florida, 32514, United States

Location

Integral Rheumatology & Immunology Specialists (IRIS)

Plantation, Florida, 33324, United States

Location

Progressive Medical Research

Port Orange, Florida, 32127, United States

Location

Drug Studies America

Marietta, Georgia, 30060, United States

Location

Georgia Institute For Clinical Research LLC

Marietta, Georgia, 30060, United States

Location

North Georgia Clinical Research

Woodstock, Georgia, 30189, United States

Location

Chicago Clinical Research Institute, Inc

Chicago, Illinois, 60607, United States

Location

Affinity Clinical Research Institute

Oak Lawn, Illinois, 60453, United States

Location

Clinical Research Advantage, Inc.

Evansville, Indiana, 47714, United States

Location

MediSphere Medical Research Center, LLC

Evansville, Indiana, 47714, United States

Location

L-MARC Research Center

Louisville, Kentucky, 40213, United States

Location

Tandem Clinical Research

Marrero, Louisiana, 70072, United States

Location

Tufts Medical Center, Inc.

Boston, Massachusetts, 02111, United States

Location

Great Lakes Research Group, Inc.

Bay City, Michigan, 48706, United States

Location

Onyx Clinical Research

Caro, Michigan, 48723, United States

Location

Synexus Clinical Research US, Inc.

Richfield, Minnesota, 55423, United States

Location

Skyline Medical Center /Radiant Research, Inc.

Elkhorn, Nebraska, 68022, United States

Location

Meridian Clinical Research Associates, LLC

Omaha, Nebraska, 68134, United States

Location

Robert Kaplan, D.O.

Las Vegas, Nevada, 89144, United States

Location

Amici Clinical Research, LLC

Raritan, New Jersey, 08869, United States

Location

Albuquerque Clinical Trials, Inc.

Albuquerque, New Mexico, 87102, United States

Location

Drug Trial Brooklyn

Brooklyn, New York, 11230, United States

Location

Northwell Health

Great Neck, New York, 11021, United States

Location

Drug Trials America

Hartsdale, New York, 10530, United States

Location

Upstate Clinical Research Associates, LLC

Williamsville, New York, 14221, United States

Location

Carolina Research Center

Shelby, North Carolina, 28150, United States

Location

PMG Research of Wilmington LLC

Wilmington, North Carolina, 28401, United States

Location

The Center For Clinical Research

Winston-Salem, North Carolina, 27103, United States

Location

New Horizons Clinical Research

Cincinnati, Ohio, 45242, United States

Location

Aventiv Research Inc

Columbus, Ohio, 43213, United States

Location

DOC Clinical Research

Dayton, Ohio, 45432, United States

Location

Center for Orthopaedics and Sports Medicine

Indiana, Pennsylvania, 15701, United States

Location

Radiant Research, Inc.

Anderson, South Carolina, 29621, United States

Location

Piedmont Comprehensive Pain Management Group

Greenville, South Carolina, 29601, United States

Location

Radiant Research, Inc.

Greer, South Carolina, 29651, United States

Location

Coastal Carolina Research Center at LowCountry Orthopaedics

North Charleston, South Carolina, 29406, United States

Location

Piedmont Research Partners, LLC

Old Point Station, South Carolina, 29707, United States

Location

ACME Research, LLC

Orangeburg, South Carolina, 29118, United States

Location

Office of Dr.Ramesh C. Gupta MD

Memphis, Tennessee, 38119, United States

Location

West Texas Clinical Research

Lubbock, Texas, 79410, United States

Location

Clinical Investigations Of Texas

Plano, Texas, 75075, United States

Location

Synexus USA

Plano, Texas, 75093, United States

Location

Charlottesville Medical Research Center LLC

Charlottesville, Virginia, 22911, United States

Location

Health Research of Hampton Roads, Inc

Newport News, Virginia, 23606, United States

Location

Spokane Joint Replacement Center

Spokane, Washington, 99218, United States

Location

Related Publications (1)

• DiMartino SJ, Gao H, Eng S, Valenzuela G, Fuerst T, Emeremni C, Ho T, Hassan HE, Turner KC, Davis JD, Zaim S, Chao J, Patel Y, Brener L, Trinh N, Manvelian G, Fetell M, Braunstein N, Geba GP, Dakin P. Efficacy and safety of fasinumab in an NSAID-controlled study in patients with pain due to osteoarthritis of the knee or hip. BMC Musculoskelet Disord. 2025 Feb 25;26(1):192. doi: 10.1186/s12891-025-08402-8.

  PMID: 40001000 DERIVED

MeSH Terms

Conditions

Osteoarthritis, Knee; Osteoarthritis, Hip

Interventions

fasinumab; Diclofenac; Celecoxib

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylacetates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzenesulfonamides; Sulfonamides; Amides; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Sulfones; Sulfur Compounds; Pyrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Clinical Trials Administrator
• 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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 2, 2017
• First Posted: October 9, 2017
• Study Start: October 26, 2017
• Primary Completion: December 13, 2019
• Study Completion: November 9, 2020
• Last Updated: February 24, 2023
• Results First Posted: February 24, 2023

Record last verified: 2023-01

Locations

US (71)