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Osteoarthritis, KneePhase 2/3NCT02447276

Study of REGN475 in Patients With Pain Due to Osteoarthritis of the Knee or Hip

A Phase 2/3 study testing REGN475 in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 72 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 40 to 80 years
Conditions the study is for
Osteoarthritis, Knee, Osteoarthritis, Hip
What is being tested?
REGN475
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
421 participants
Where
72 sitesUnited States
Study dates
May 2015to Nov 2016
Phase
Phase 2/3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

72 sites in 1 country.

72 sites in 1 country

United States72 sites

  • Study site

    Anaheim, California

  • Study site

    Bensalem, Pennsylvania

  • Study site

    Beverly Hills, California

  • Study site

    Birmingham, Alabama

  • Study site

    Brooklyn, New York

  • Study site

    Chandler, Arizona

  • Study site

    Charlotte, North Carolina

  • Study site

    Chicago, Illinois

  • Study site

    Cincinnati, Ohio

  • Study site

    Clearwater, Florida

  • Study site

    Cleveland, Ohio

  • Study site

    Cypress, Texas

  • Study site

    Dallas, Texas

  • Study site

    Decatur, Georgia

  • Study site

    Duncansville, Pennsylvania

  • Study site

    El Cajon, California

  • Study site

    Elkridge, Maryland

  • Study site

    Fleming Island, Florida

  • Study site

    Frederick, Maryland

  • Study site

    Hartsdale, New York

  • Study site

    Hattiesburg, Mississippi

  • Study site

    High Point, North Carolina

  • Study site

    Honolulu, Hawaii

  • Study site

    Hot Spring, Arkansas

  • Study site

    Indianapolis, Indiana

  • Study site

    Jackson, Tennessee

  • Study site

    Jacksonville, Florida

  • Study site

    Jefferson City, Tennessee

  • Study site

    Jenkintown, Pennsylvania

  • Study site

    Kansas City, Missouri

  • Study site

    Lakewood, Colorado

  • Study site

    Little Rock, Arkansas

  • Study site

    Lubbock, Texas

  • Study site

    Memphis, Tennessee

  • Study site

    Mesquite, Texas

  • Study site

    Miami, Florida

  • Study site

    Mobile, Alabama

  • Study site

    Mt. Pleasant, South Carolina

  • Study site

    New Orleans, Louisiana

  • Study site

    New York, New York

  • Study site

    Norfolk, Virginia

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Omaha, Nebraska

  • Study site

    Orlando, Florida

  • Study site

    Palm Harbor, Florida

  • Study site

    Phoenix, Arizona

  • Study site

    Plainview, New York

  • Study site

    Plano, Texas

  • Study site

    Raleigh, North Carolina

  • Study site

    Rochester, New York

  • Study site

    Sacramento, California

  • Study site

    Saint Clair Shores, Michigan

  • Study site

    Salt Lake City, Utah

  • Study site

    San Diego, California

  • Study site

    Sandy City, Utah

  • Study site

    Santa Ana, California

  • Study site

    St Louis, Missouri

  • Study site

    Tamarac, Florida

  • Study site

    Tampa, Florida

  • Study site

    Thousand Oaks, California

  • Study site

    Traverse City, Michigan

  • Study site

    Tulsa, Oklahoma

  • Study site

    Tuscon, Arizona

  • Study site

    Upland, California

  • Study site

    Waco, Texas

  • Study site

    Walnut Creek, California

  • Study site

    Warwick, Rhode Island

  • Study site

    West Jordan, Utah

  • Study site

    West Palm Beach, Florida

  • Study site

    Weston, Florida

  • Study site

    Winter Haven, Florida

  • Study site

    Worcester, Massachusetts

Other trials in United States

About this study

Official title: 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

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.

Being tested
REGN475, Placebo
Medical subject headings
Osteoarthritis, Knee, Osteoarthritis, Hip

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • REGN475Drug

  • PlaceboDrug

Study groups in NCT02447276
Study groupRoleWhat they receive
Group AExperimentalGroup A will receive REGN475 dosing regimen 1
Receives: Drug: REGN475
Group BExperimentalGroup B will receive REGN475 dosing regimen 2
Receives: Drug: REGN475
Group CExperimentalGroup C will receive REGN475 dosing regimen 3
Receives: Drug: REGN475
Group DExperimentalGroup D will receive REGN475 dosing regimen 4
Receives: Drug: REGN475
Group EExperimentalGroup E will receive matching placebo
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Baseline to week 16

Secondary outcomes (4)

  1. Change from baseline to week 16 in the WOMAC physical function subscale score

    Measured: Baseline to week 16

  2. Change from baseline to week 16 in the Patient Global Assessment score

    Measured: Baseline to week 16

  3. Incidence of treatment-emergent adverse events (TEAEs)

    Measured: Baseline to week 36 (end of study)

  4. Incidence of anti-REGN475 antibody development

    Measured: Baseline to week 36 (end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 May 2015 (estimated)
  2. Study startMay 2015
  3. Primary completionMar 2016
  4. Study completionNov 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
421 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02447276
Sponsor's protocol ID
R475-PN-1227
Status last verified
Oct 2016
First submitted
14 May 2015
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 41323020

  • Dakin 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.

    PubMed 31207169

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing REGN475 in people with Osteoarthritis, Knee and Osteoarthritis, Hip, run by Regeneron Pharmaceuticals at 72 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 72 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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. (time frame: Baseline to week 16). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02447276, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2017.

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