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

March 24, 2017 updated by: Regeneron Pharmaceuticals

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

421

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States
      • Mobile, Alabama, United States
    • Arizona
      • Chandler, Arizona, United States
      • Phoenix, Arizona, United States
      • Tuscon, Arizona, United States
    • Arkansas
      • Hot Spring, Arkansas, United States
      • Little Rock, Arkansas, United States
    • California
      • Anaheim, California, United States
      • Beverly Hills, California, United States
      • El Cajon, California, United States
      • Sacramento, California, United States
      • San Diego, California, United States
      • Santa Ana, California, United States
      • Thousand Oaks, California, United States
      • Upland, California, United States
      • Walnut Creek, California, United States
    • Colorado
      • Lakewood, Colorado, United States
    • Florida
      • Clearwater, Florida, United States
      • Fleming Island, Florida, United States
      • Jacksonville, Florida, United States
      • Miami, Florida, United States
      • Orlando, Florida, United States
      • Palm Harbor, Florida, United States
      • Tamarac, Florida, United States
      • Tampa, Florida, United States
      • West Palm Beach, Florida, United States
      • Weston, Florida, United States
      • Winter Haven, Florida, United States
    • Georgia
      • Decatur, Georgia, United States
    • Hawaii
      • Honolulu, Hawaii, United States
    • Illinois
      • Chicago, Illinois, United States
    • Indiana
      • Indianapolis, Indiana, United States
    • Louisiana
      • New Orleans, Louisiana, United States
    • Maryland
      • Elkridge, Maryland, United States
      • Frederick, Maryland, United States
    • Massachusetts
      • Worcester, Massachusetts, United States
    • Michigan
      • St. Clair Shores, Michigan, United States
      • Traverse City, Michigan, United States
    • Mississippi
      • Hattiesburg, Mississippi, United States
    • Missouri
      • Kansas City, Missouri, United States
      • St. Louis, Missouri, United States
    • Nebraska
      • Omaha, Nebraska, United States
    • New York
      • Brooklyn, New York, United States
      • Hartsdale, New York, United States
      • New York, New York, United States
      • Plainview, New York, United States
      • Rochester, New York, United States
    • North Carolina
      • Charlotte, North Carolina, United States
      • High Point, North Carolina, United States
      • Raleigh, North Carolina, United States
    • Ohio
      • Cincinnati, Ohio, United States
      • Cleveland, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
      • Tulsa, Oklahoma, United States
    • Pennsylvania
      • Bensalem, Pennsylvania, United States
      • Duncansville, Pennsylvania, United States
      • Jenkintown, Pennsylvania, United States
    • Rhode Island
      • Warwick, Rhode Island, United States
    • South Carolina
      • Mount Pleasant, South Carolina, United States
    • Tennessee
      • Jackson, Tennessee, United States
      • Jefferson City, Tennessee, United States
      • Memphis, Tennessee, United States
    • Texas
      • Cypress, Texas, United States
      • Dallas, Texas, United States
      • Lubbock, Texas, United States
      • Mesquite, Texas, United States
      • Plano, Texas, United States
      • Waco, Texas, United States
    • Utah
      • Salt Lake City, Utah, United States
      • Sandy, Utah, United States
      • West Jordan, Utah, United States
    • Virginia
      • Norfolk, Virginia, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Body mass index ≤39
  2. Clinical diagnosis of OA of the knee or hip
  3. History of inadequate pain relief or intolerance to analgesics used for OA
  4. Moderate to severe pain in the index joint
  5. History of regular use of analgesic medications for OA pain
  6. Willing to discontinue current non-steroidal anti-inflammatory drug (NSAID) and opioid pain medications

Key Exclusion Criteria:

  1. 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
  2. History of osteonecrosis, destructive arthropathy (RPOA), hip dislocation, pathologic fractures, neuropathic joint arthropathy, knee dislocation or hip dislocation
  3. Trauma to the index joint in the 30 days before screening
  4. 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
  5. 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
  6. Presence of subchondral insufficiency fracture on screening films or MRI
  7. Received an intra-articular injection of hyaluronic acid in the affected index joint within 90 days prior to the screening visit
  8. 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.
  9. History of autonomic neuropathy, diabetic neuropathy, or presence of clinically relevant peripheral neuropathy at the time of screening
  10. Women of childbearing potential who have a positive pregnancy test result, or who do not have their pregnancy test results at baseline
  11. Pregnant or breastfeeding women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A
Group A will receive REGN475 dosing regimen 1
Drug: REGN475
Experimental: Group B
Group B will receive REGN475 dosing regimen 2
Drug: REGN475
Experimental: Group C
Group C will receive REGN475 dosing regimen 3
Drug: REGN475
Experimental: Group D
Group D will receive REGN475 dosing regimen 4
Drug: REGN475
Experimental: Group E
Group E will receive matching placebo
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Baseline to week 16

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline to week 16 in the WOMAC physical function subscale score
Time Frame: Baseline to week 16
Baseline to week 16
Change from baseline to week 16 in the Patient Global Assessment score
Time Frame: Baseline to week 16
Baseline to week 16
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Baseline to week 36 (end of study)
Baseline to week 36 (end of study)
Incidence of anti-REGN475 antibody development
Time Frame: Baseline to week 36 (end of study)
Baseline to week 36 (end of study)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

May 14, 2015

First Submitted That Met QC Criteria

May 14, 2015

First Posted (Estimate)

May 18, 2015

Study Record Updates

Last Update Posted (Actual)

March 27, 2017

Last Update Submitted That Met QC Criteria

March 24, 2017

Last Verified

October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R475-PN-1227

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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