Study of efficacy, safety and tolerability of DFV890 in patients with knee osteoarthritis

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 108

Inclusion Criteria

Key Inclusion Criteria:
• Male and female participants >= 50 and <= 80 years old on the day of Informed Consent signature.
• Participants must weigh at least 50 kg to participate in the study, and must have a body mass index (BMI) within the range of 18 - 35 kg/m2 at screening. BMI = Body weight (kg) / [Height (m)]2 • High sensitivity C-reactive protein (hsCRP) >=2 mg/L at screening • Symptomatic OA with pain (Numeric Rating Scale [NRS] 5-9, inclusive) in the target knee for the majority of days in the last 3 months prior to screening • KOOS pain sub-scale score <= 60 in index knee at screening and baseline • Radiographic disease: K&L grade 2 or 3 knee osteoarthritis and joint space width 2-4 mm for males and 1.5-3.5 mm for females in the medial tibiofemoral compartment (TFC) in the target knee • Active synovial inflammation at screening, defined as either moderate (score 9-12) or severe (score >=13) based on contrast enhanced MRI (CE-MRI) of the whole knee for synovitis detection from 11 sites

Please refer to protocol section 5.1 for an exhaustive list of inclusion criteria
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 54
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 54

Exclusion Criteria

Key Exclusion Criteria:
• Total WBC count < 3,000/µL, absolute peripheral blood neutrophil count (ANC) < 1,000/µL, hemoglobin < 8.5 g/dL (85 g/L) or platelet count < 100,000/µL at Screening • Known autoimmune disease with inflammatory arthritis (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal-induced arthritis (gout, pseudogout associated arthritis), active acute or chronic infection or past infection of the knee joint, Lyme disease involving the knee, reactive arthritis, systemic cartilage disorders, moderate to severe fibromyalgia (widespread pain index, WPI, >4 out of 19), or a known systemic connective tissue disease • Any known active infections, including skin or knee infections or infections that may compromise the immune system, such as HIV or chronic hepatitis B or C infection • Use of prohibited medications: any local i.e. treatment into the knee, including but not restricted to viscosupplementation and corticosteroids within 12 weeks prior to Day 1; long-term treatment (>14 days) with oral corticosteroids >5 mg/day within 4 weeks prior to Day 1; oral glucosamine, chondroitin sulfate, or any nutraceutical with potential activity on cartilage repair within 2 weeks prior to Day 1; systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs) or selective COX-2 inhibitors within 5 half-lives from PRO assessments; any other immunomodulatory drugs or treatment which cannot be discontinued or switched to a different medication within 28 days or 5 half-lives of screening (whichever is longer if required by local regulations), or until the expected PD effect has returned to baseline.
• Contralateral knee pain >=4 by NRS for the majority of days in the last 3 months prior to Screening • Participants with the CYP2C9 *3/*3 genotype defined as homozygous carriers of the CYP2C9*3 allele.
• Severe malalignment greater than 7.5 degrees in the target knee (either varus or valgus), measured using x-ray at Screening

Please refer to protocol section 5.2 for an exhaustive list of exclusion criteria

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To determine the efficacy of oral DFV890 vs. placebo in participants with knee OA for relieving OA pain;Secondary Objective: 1) To assess the efficacy of DFV890 vs. placebo in participants with knee OA on inflammatory joint structure features<br>2) To assess the safety and tolerability of DFV890 vs. placebo<br>3) To assess the effect of DFV890 compared to placebo on systemic inflammatory status<br>4) To assess pharmacokinetics of DFV890 in plasma<br>5) To assess the efficacy of DFV890 vs. placebo in improving participants' report of knee symptoms and associated problems over time<br>6) To assess the efficacy of DFV890 vs. placebo in relieving OA pain over time;Primary end point(s): Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12 Time Frame: Baseline to Week 12;Timepoint(s) of evaluation of this end point: Time Frame: Baseline to Week 12

Secondary Outcome Measures

Name	Time	Method

Updated 8/28/2023

Study of efficacy, safety and tolerability of DFV890 in patients with knee osteoarthritis

Recruitment & Eligibility

Study & Design

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