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

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 2

Conditions: Osteoarthritis of the Knee; Pain

Treatments: Drug: REGN5069; Drug: Matching Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03956550

R5069-OA-1849

Details and patient eligibility

About

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

Enrollment: 259 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key 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

Key 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

Note: Other protocol defined inclusion/exclusion criteria apply.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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259 participants in 3 patient groups

REGN5069 Low Dose

Experimental group

Description:

Randomized in a 1:1:1 ratio

Treatment:

Drug: REGN5069

REGN5069 High Dose

Experimental group

Description:

Randomized in a 1:1:1 ratio

Treatment:

Drug: REGN5069

Matching Placebo

Experimental group

Description:

Randomized in a 1:1:1 ratio

Treatment:

Drug: Matching Placebo