---
title: A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee
nct_id: NCT01239017
overall_status: WITHDRAWN
phase: PHASE2
sponsor: Regeneron Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Osteoarthritis
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT01239017.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT01239017"
ct_last_update_post_date: 2015-03-18
last_seen_at: "2026-05-12T06:50:01.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of the Safety and Efficacy of Subcutaneously Administered REGN475 in Patients With Osteoarthritis of the Knee

**Official Title:** 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

**NCT ID:** [NCT01239017](https://clinicaltrials.gov/study/NCT01239017)

## Key Facts

- **Status:** WITHDRAWN
- **Phase:** PHASE2
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 0
- **Lead Sponsor:** Regeneron Pharmaceuticals
- **Collaborators:** Sanofi
- **Conditions:** Osteoarthritis
- **CT.gov Last Update:** 2015-03-18

## 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.

## Eligibility

- **Minimum age:** 40 Years
- **Maximum age:** 75 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
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.
```

## Arms

- **Dose 1** (EXPERIMENTAL) — SC REGN475 Dose 1 and IV Placebo
- **Dose 2** (EXPERIMENTAL) — SC REGN475 Dose 2 and IV Placebo
- **Dose 3** (EXPERIMENTAL) — SC REGN475 Dose 3 and IV Placebo
- **Dose 4** (EXPERIMENTAL) — SC Placebo and IV REGN475 Dose 4
- **Dose 5** (PLACEBO_COMPARATOR) — SC Placebo and IV Placebo

## Interventions

- **REGN475** (BIOLOGICAL)
- **Placebo** (OTHER)

## Primary Outcomes

- **The incidence of treatment-emergent adverse events (TEAEs) in patients treated with REGN475 or placebo.** _(time frame: 16 weeks)_

## Secondary Outcomes

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

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `sponsor.collaborators` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT01239017.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT01239017*  
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