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

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized,Double Blind,Placebo-controlled,Parallel Group,Repeat Dose Study of the Safety and Efficacy of REGN475 in Patients With Osteoarthritis of the Knee

Conditions
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Osteoarthritis of the Knee

Intervention / Treatment
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* Drug: REGN475
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women ≥ 40 and ≤ 75 years of age. 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. Kellgren-Lawrence grade 2-3 radiographic severity of the index knee at or within 6 months prior to Screening. Exclusion Criteria: 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. Patients with joint replacement in the affected knee. Patients with peripheral neuropathy due to any reason.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose 1<br> | Drug: REGN475<br>* 2 Administrations of REGN475 within 24 weeks.<br>|
| Experimental: Dose 2<br> | Drug: REGN475<br>* 2 Administrations of REGN475 within 24 weeks.<br>|
| Experimental: Dose 3<br> | Drug: REGN475<br>* 2 Administrations of REGN475 within 24 weeks.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Placebo to match REGN475 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of TEAEs in patients treated with REGN475 or placebo, reported between administration of study drug on Day 1 and the completion of study at the end of week 24 (Day 169). |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC) (total score as well as all 3 subscales: pain, stiffness and function). |  | 24 weeks | 
| Patient assessment of response to treatment over time using the Patient Global Impression of Change. |  | 24 weeks | 
| Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12). |  | 24 weeks |