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

Regeneron Pharmaceuticals

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Conditions

Osteoarthritis

Interventions

REGN475BIOLOGICAL

PlaceboOTHER

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.

Time frame: 16 weeks

Secondary Outcomes

Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).

Time frame: 8 weeks

Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).

Time frame: 8 weeks

Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)

Time frame: 8 weeks

Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)

Time frame: 8 weeks

Patient assessment of response to treatment over time using the Patient Global Impression of Change.

Time frame: 16 weeks

Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).

Time frame: 8 weeks

Data from ClinicalTrials.gov

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