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

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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944892

Enrollment

200

Registered

2009-07-23

Start date

2009-08-31

Completion date

2010-05-31

Last updated

2011-12-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Osteoarthritis of the Knee

Brief summary

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.

Interventions

DRUGREGN475

2 Administrations of REGN475 within 24 weeks.

OTHERPlacebo

Placebo to match REGN475 doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

40 Years to 75 Years

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.

Design outcomes

Primary

Measure	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

Measure	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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026