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

Regeneron Pharmaceuticals

Status and phase: Withdrawn; Phase 2

Conditions: Osteoarthritis

Treatments: Biological: REGN475; Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01239017

R475-PN-1004

Details and patient eligibility

About

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.

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

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0 participants in 5 patient groups, including a placebo group

Dose 1

Experimental group

Description:

SC REGN475 Dose 1 and IV Placebo

Treatment:

Biological: REGN475

Dose 2

Experimental group

Description:

SC REGN475 Dose 2 and IV Placebo

Treatment:

Biological: REGN475

Dose 3

Experimental group

Description:

SC REGN475 Dose 3 and IV Placebo

Treatment:

Biological: REGN475

Dose 4

Experimental group

Description:

SC Placebo and IV REGN475 Dose 4

Treatment:

Biological: REGN475

Dose 5

Placebo Comparator group

Description:

SC Placebo and IV Placebo

Treatment:

Other: Placebo