A Study of the Safety and Efficacy of REGN475(SAR164877) in Patients With Osteoarthritis of the Knee

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2; Phase 1

Conditions: Osteoarthritis of the Knee

Treatments: Drug: REGN475; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00944892

R475-PN-0901

Details and patient eligibility

About

This is a double-blind, prospective, randomized study in which patients will be randomized to 1 of 4 treatment arms (3 active and 1 placebo).

Each patient will receive two doses of active medication or placebo, with study drug administered intravenously (IV). The primary goal of the study is to assess the safety and tolerability of repeat administrations of REGN475 compared to placebo in patients with osteoarthritis (OA) of the knee.

Enrollment: 200 patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Men and women ≥ 40 and ≤ 75 years of age.
2. 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.
3. 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. Patients with peripheral neuropathy due to any reason.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 4 patient groups, including a placebo group

Dose 1

Experimental group

Treatment:

Drug: REGN475

Dose 2

Experimental group

Treatment:

Drug: REGN475

Dose 3

Experimental group

Treatment:

Drug: REGN475

Placebo

Placebo Comparator group

Treatment:

Other: Placebo