2023-507559-30-00已完成2 期
A randomized, two-arm, placebo-controlled, participant and investigator-blinded study investigating the efficacy, safety and tolerability of DFV890 in patients with symptomatic knee osteoarthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 24
- 主要终点
- Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12
研究概览
简要总结
To determine the efficacy of DFV890 versus placebo in participants with knee Osteoarthritis (OA) for relieving pain, based on change from baseline to week 12 in the knee injury and osteoarthritis outcome score (KOOS) pain sub-scale.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •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) >=1.8 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 in the target knee
- •Active synovial inflammation at screening, (defined as summary score >=7 with at least one region scoring 2) on contrast enhanced MRI (CE-MRI) of the whole knee for synovitis detection from 11 sites
排除标准
- •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 arthritides (including but not limited to rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, systemic lupus erythematosus), crystal-induced arthritides (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. COVID-19 specific: Polymerase Chain Reaction (P.C.R.) or antigen test against COVID-19 is mandatory where required by the local Health Authority and/or by local regulation, e.g. in Germany.
- •Use of prohibited medications: any local i.a. 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 from screening 1; systemic Non-Steroidal Anti-Inflammatory Drugs (NSAIDs), selective Cyclooxygenase-2 (COX-2) inhibitors or other non-opioid analgesics not defined as basic pain medication 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.
- •Moderate to severe pain in the contralateral knee for the majority of days in the last 3 months prior to Screening, as per patient judgment
- •Severe malalignment greater than 7.5 degrees in the target knee (either varus or valgus), measured using x-ray at Screening.
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of drugs, or which may jeopardize the patient in case of participation in the study. The investigator should make this determination in consideration of the patient's medical history and/or clinical or laboratory assessments, in consultation with the Sponsor when necessary.
结局指标
主要结局
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12
Change from baseline in Knee injury and Osteoarthritis Outcome Score (KOOS) pain sub-scale at week 12
次要结局
- Change from baseline in synovitis activity level measured from K-trans by DCE-MRI at week 12
- Change in numeric rating scale (NRS) for pain from baseline to weeks 2, 4, 8 and 12
- Systemic and local Adverse Events and Serious Adverse Events, Electrocardiograms (ECGs) parameters, Vital signs, Hematology, blood chemistry and urinalysis.
- Change from baseline in serum high sensitivity C-reactive protein level and absolute neutrophil counts at week 2,4,8 and 12
- Plasma samples to quantify concentrations of DFV890 at various time points (week 2 and week 12) and to derive PK parameters in plasma (including but not limited to Cmax, AUC last, AUC0-12h, and Cthrough)
- Change from baseline in KOOS sub-scales (other symptoms, function in daily living, function in sport and recreation, knee-related quality of life) at weeks 2, 4, 8 and 12
- Change in KOOS pain subscale from baseline to weeks 2, 4, 8 and 12
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (24)
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