Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
A Randomized, Double-Blind, Multi-Dose, Placebo-Controlled Study to Evaluate the Efficacy and Safety of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip
1 other identifier
interventional
421
1 country
72
Brief Summary
The primary objective of this study is to evaluate the effectiveness of REGN475 compared to placebo in participants with pain due to osteoarthritis (OA) of the knee or hip and a history of inadequate joint pain relief or intolerance to current analgesic therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started May 2015
Shorter than P25 for phase_2
72 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2015
CompletedFirst Submitted
Initial submission to the registry
May 14, 2015
CompletedFirst Posted
Study publicly available on registry
May 18, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2016
CompletedMarch 27, 2017
October 1, 2016
10 months
May 14, 2015
March 24, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
The primary endpoint in the study is the change from baseline to week 16 in the Western Ontario and McMaster Osteoarthritis Index (WOMAC) pain subscale score.
Baseline to week 16
Secondary Outcomes (4)
Change from baseline to week 16 in the WOMAC physical function subscale score
Baseline to week 16
Change from baseline to week 16 in the Patient Global Assessment score
Baseline to week 16
Incidence of treatment-emergent adverse events (TEAEs)
Baseline to week 36 (end of study)
Incidence of anti-REGN475 antibody development
Baseline to week 36 (end of study)
Study Arms (5)
Group A
EXPERIMENTALGroup A will receive REGN475 dosing regimen 1
Group B
EXPERIMENTALGroup B will receive REGN475 dosing regimen 2
Group C
EXPERIMENTALGroup C will receive REGN475 dosing regimen 3
Group D
EXPERIMENTALGroup D will receive REGN475 dosing regimen 4
Group E
EXPERIMENTALGroup E will receive matching placebo
Interventions
Eligibility Criteria
You may qualify if:
- Body mass index ≤39
- Clinical diagnosis of OA of the knee or hip
- History of inadequate pain relief or intolerance to analgesics used for OA
- Moderate to severe pain in the index joint
- History of regular use of analgesic medications for OA pain
- Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications
You may not qualify if:
- Other diseases that may involve index knee or hip, including inflammatory joint diseases, crystalline disease (gout or pseudogout), endocrinopathies, metabolic joint disease, lupus erythematosus, rheumatoid arthritis, joint infections, neuropathic disorders, avascular necrosis, Paget's disease, renal osteodystrophy or tumors
- History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation
- Trauma to the index joint in the 30 days before screening
- Active fibromyalgia, regional pain caused by lumbar or cervical compression with radiculopathy or other moderate to severe pain that may confound assessments or self-evaluation of the pain associated with OA
- Prior to the start of the study has received a recommendation for, or is scheduled for joint replacement surgery to be performed during the study period
- Presence of subchondral insufficiency fracture on screening films or MRI
- Received an intra-articular injection of hyaluronic acid in the affected index joint within 90 days prior to the screening visit
- Systemic (ie, oral or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks of the screening visit, or to any other joint within 30 days prior to the screening visit.
- History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening
- Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline
- Pregnant or breastfeeding women
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (72)
Unknown Facility
Birmingham, Alabama, United States
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Mobile, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Tuscon, Arizona, United States
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Hot Spring, Arkansas, United States
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Little Rock, Arkansas, United States
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Anaheim, California, United States
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Beverly Hills, California, United States
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El Cajon, California, United States
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Sacramento, California, United States
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San Diego, California, United States
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Santa Ana, California, United States
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Thousand Oaks, California, United States
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Upland, California, United States
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Walnut Creek, California, United States
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Lakewood, Colorado, United States
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Clearwater, Florida, United States
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Fleming Island, Florida, United States
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Jacksonville, Florida, United States
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Miami, Florida, United States
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Orlando, Florida, United States
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Palm Harbor, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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West Palm Beach, Florida, United States
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Weston, Florida, United States
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Winter Haven, Florida, United States
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Decatur, Georgia, United States
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Honolulu, Hawaii, United States
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Chicago, Illinois, United States
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Indianapolis, Indiana, United States
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New Orleans, Louisiana, United States
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Elkridge, Maryland, United States
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Frederick, Maryland, United States
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Worcester, Massachusetts, United States
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Saint Clair Shores, Michigan, United States
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Traverse City, Michigan, United States
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Hattiesburg, Mississippi, United States
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Kansas City, Missouri, United States
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St Louis, Missouri, United States
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Omaha, Nebraska, United States
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Brooklyn, New York, United States
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Hartsdale, New York, United States
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New York, New York, United States
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Plainview, New York, United States
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Rochester, New York, United States
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Charlotte, North Carolina, United States
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High Point, North Carolina, United States
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Raleigh, North Carolina, United States
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Cincinnati, Ohio, United States
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Cleveland, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Tulsa, Oklahoma, United States
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Bensalem, Pennsylvania, United States
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Duncansville, Pennsylvania, United States
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Jenkintown, Pennsylvania, United States
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Warwick, Rhode Island, United States
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Mt. Pleasant, South Carolina, United States
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Jackson, Tennessee, United States
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Jefferson City, Tennessee, United States
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Memphis, Tennessee, United States
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Cypress, Texas, United States
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Dallas, Texas, United States
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Lubbock, Texas, United States
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Mesquite, Texas, United States
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Plano, Texas, United States
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Waco, Texas, United States
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Salt Lake City, Utah, United States
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Sandy City, Utah, United States
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West Jordan, Utah, United States
Unknown Facility
Norfolk, Virginia, United States
Related Publications (2)
Eng S, Fetell M, Gao H, Mei J, Trejos J, Cortes-Burgos L, Ho T, Manvelian G, Patel Y, Trinh N, Turner KC, Hassan HE, DiMartino S, Krueger P, Geba GP, Braunstein N, Macdonald LE, Soltys R, Croll SD, Dakin P. The Effects of Fasinumab on Peripheral Nerve Function and Ganglion Anatomy: Results From a Randomized, Double-Blind, Placebo-Controlled Study in Patients With Pain Due to Osteoarthritis of the Knee or Hip, and a Series of Nonclinical Studies. Curr Ther Res Clin Exp. 2025 Oct 24;103:100813. doi: 10.1016/j.curtheres.2025.100813. eCollection 2025.
PMID: 41323020DERIVEDDakin P, DiMartino SJ, Gao H, Maloney J, Kivitz AJ, Schnitzer TJ, Stahl N, Yancopoulos GD, Geba GP. The Efficacy, Tolerability, and Joint Safety of Fasinumab in Osteoarthritis Pain: A Phase IIb/III Double-Blind, Placebo-Controlled, Randomized Clinical Trial. Arthritis Rheumatol. 2019 Nov;71(11):1824-1834. doi: 10.1002/art.41012. Epub 2019 Sep 20.
PMID: 31207169DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 2
- 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
May 14, 2015
First Posted
May 18, 2015
Study Start
May 1, 2015
Primary Completion
March 1, 2016
Study Completion
November 1, 2016
Last Updated
March 27, 2017
Record last verified: 2016-10