A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee

NCT ID: NCT03956550

Last Updated: 2021-07-01

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 259 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-21
• Study Completion Date: 2020-10-29

Brief Summary

The primary objective of the study is to evaluate the efficacy of REGN5069 compared to placebo in patients with pain due to radiographically-confirmed OA of the knee who have a history of inadequate joint pain relief or intolerance to current analgesic therapy.

The secondary objectives of the study are:

• To characterize the concentrations of functional REGN5069 in serum over time when patients are treated for up to 12 weeks
• To assess the safety and tolerability of REGN5069 compared with placebo when patients are treated for up to 12 weeks
• To measure levels of anti-drug antibodies (ADAs) against REGN5069 following multiple IV administrations

Conditions

Osteoarthritis of the Knee; Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

REGN5069 Low Dose

Randomized in a 1:1:1 ratio

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

Intravenous (IV) Dose every 4 weeks (Q4W)

REGN5069 High Dose

Randomized in a 1:1:1 ratio

Group Type: EXPERIMENTAL

REGN5069

Intervention Type: DRUG

Intravenous (IV) Dose every 4 weeks (Q4W)

Matching Placebo

Randomized in a 1:1:1 ratio

Group Type: EXPERIMENTAL

Matching Placebo

Intervention Type: DRUG

Intravenous (IV) Dose every 4 weeks (QW4)

Interventions

REGN5069

Intravenous (IV) Dose every 4 weeks (Q4W)

Intervention Type: DRUG

Matching Placebo

Intravenous (IV) Dose every 4 weeks (QW4)

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Generally in good health at the screening visit
• Body mass index (BMI) ≤39 kg/m2 at the screening visit
• Clinical diagnosis of OA of the knee on the American College of Rheumatology criteria (Altman, 1986) with radiologic evidence of OA (K-L score ≥2) at the index joint at the screening visit
• Moderate-to-severe pain in the index joint
• A history of inadequate pain relief from or intolerance to analgesics used for OA

Exclusion Criteria

• Diagnosis of systemic diseases that may affect joints
• History or presence of osteonecrosis, destructive arthropathy, neuropathic joint arthropathy, pathologic fractures in any shoulder, hip, or knee joint(s), hip dislocation (prosthetic hip dislocation is eligible), or knee dislocation (patella dislocation is eligible) at the screening visit. Presence of subchondral insufficiency fracture on screening films or MRI as assessed by the central imaging reader.
• Is scheduled for a joint replacement surgery to be performed during the study period
• Received an intra-articular injection of hyaluronic acid in any joint within 90 days prior to the screening visit
• Systemic (ie, IV, oral, or intramuscular) corticosteroids within 30 days prior to the screening visit. Intra-articular corticosteroids in the index joint within 12 weeks prior to the screening visit, or to any other joint within 30 days prior to the screening visit (topical, intranasal, or inhaled corticosteroids are permitted).
• History or presence at the screening visit of multiple sclerosis, autonomic neuropathy, diabetic neuropathy, or other peripheral neuropathy
• Significant concomitant illness including, but not limited to, psychiatric, cardiac, renal, hepatic, neurological, endocrinological, metabolic, or lymphatic disease that, in the opinion of the investigator, would adversely affect the patient's participation in the study
• History of myocardial infarction, acute coronary syndromes, transient ischemic attack, or cerebrovascular accident within 12 months prior to the screening visit

• Minimum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Regeneron Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trial Management

Role: STUDY_DIRECTOR

Regeneron Pharmaceuticals

Locations

Regeneron Study Site

DeLand, Florida, United States

Regeneron Study Site

Jupiter, Florida, United States

Regeneron Study Site

Miami, Florida, United States

Regeneron Study Site

Charleston, South Carolina, United States

Regeneron Study Site

Tbilisi, , Georgia

Regeneron Study Site

Chisinau, , Moldova

Regeneron Study Site

Lublin, Lublin Voivodeship, Poland

Regeneron Study Site

Zamość, Lublin Voivodeship, Poland

Regeneron Study Site

Warsaw, Masovian Voivodeship, Poland

Regeneron Study Site

Bialystok, Podlaskie Voivodeship, Poland

Regeneron Study Site

Zgierz, Łódź Voivodeship, Poland

Regeneron Study Site

Kyiv, , Ukraine

Countries

United States; Georgia; Moldova; Poland; Ukraine

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

R5069-OA-1849

Identifier Type: -

Identifier Source: org_study_id