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

A Randomized, Double-Blind, Placebo Controlled, Parallel Group, Single Dose Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee

Status

Withdrawn

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01239017

Enrollment

Registered

2010-11-11

Start date

Unknown

Completion date

Unknown

Last updated

2015-03-18

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

Conditions

Osteoarthritis

Brief summary

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.

Interventions

BIOLOGICALREGN475

OTHERPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

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. 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.

Design outcomes

Primary

Measure	Time frame
The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.	16 weeks

Secondary

Measure	Time frame
Change from baseline in walking knee pain using the Numeric Rating Scale (NRS).	8 weeks
Time-integrated change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)	8 weeks
Time-integrated change from baseline in walking knee pain using the Numeric Rating Scale (NRS).	8 weeks
Patient assessment of response to treatment over time using the Patient Global Impression of Change.	16 weeks
Change from baseline in patient-rated QOL using the Short-Form 12-Item Questionnaire (SF-12).	8 weeks
Change from baseline in The Western Ontario and McMaster Osteoarthritis Index (WOMAC)	8 weeks

Outcome results

None listed

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