EUCTR2020-006104-17-CZ进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 108
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •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) >=1.8 mg/L at screening • Symptomatic OA with pain (corresponding to Numeric Rating Scale [NRS] 5-9, inclusive) in the target knee for the majority of days in the last 3 months prior to screening, as per participant's judgement • 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 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
- •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
排除标准
- •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. COVID-19 specific: 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. Note that some countries may require P.C.R. testing only, e.g. Czech Republic.• Use of prohibited medications: any local i.a. treatment into the knee, including but not limited 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) or selective 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 controlateral kneefor the majority of
- •days in the last 3 months prior to Screening, as per patient judgment •
- •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
- •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.
- •Please refer to protocol section 5.2 for an exhaustive list of exclusion criteria
研究者
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