A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Brief Summary

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This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 5 treatment arms (4 active and 1 placebo).

Each patient will receive one SC injection of REGN475 or placebo and 1 IV infusion of either REGN475 or placebo, on day 1 (baseline) In order to preserve the blind, patients receiving REGN475 SC will also receive placebo IV, and patients receiving REGN475 IV will also receive placebo SC.

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Detailed Description

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Conditions

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Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Dose 1

SC REGN475 Dose 1 and IV Placebo

Group Type EXPERIMENTAL

REGN475

Intervention Type BIOLOGICAL

Dose 2

SC REGN475 Dose 2 and IV Placebo

Group Type EXPERIMENTAL

REGN475

Intervention Type BIOLOGICAL

Dose 3

SC REGN475 Dose 3 and IV Placebo

Group Type EXPERIMENTAL

REGN475

Intervention Type BIOLOGICAL

Dose 4

SC Placebo and IV REGN475 Dose 4

Group Type EXPERIMENTAL

REGN475

Intervention Type BIOLOGICAL

Dose 5

SC Placebo and IV Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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REGN475

Intervention Type BIOLOGICAL

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Diagnosis of OA of the knee according to American College of Rheumatology (ACR) criteria, and experiencing moderate to severe pain in the index knee for at least 3 months prior to the screening visit.
2. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening.

Exclusion Criteria

1. Significant concomitant illness including, but not limited to, cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease that would adversely affect the patient's participation in the study.
2. Patients with joint replacement in the affected knee.
3. Intra-articular injection of corticosteroids or hyaluronic acid in the affected knee within the 3 months prior to the screening visit.
4. Women who are pregnant or breast-feeding.

Minimum Eligible Age

40 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No