A Study to Examine the Efficacy and Safety of REGN5069 in Patients With Pain Due to Osteoarthritis of the Knee
Condition: Osteoarthritis of the Knee; Pain
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: REGN5069; Matching Placebo
Intervention description: Intravenous (IV) Dose every 4 weeks (Q4W); Intravenous (IV) Dose every 4 weeks (QW4)
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 259.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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
    

Eligibility 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.