2023-509274-28-00已完成2 期
A randomized, two-arm, placebo-controlled, participant, investigator and sponsor-blinded, proof-of-concept study investigating the efficacy, safety and tolerability of QUC398 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
- 10
- 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 assess the efficacy of q4w s.c. injections of QUC398 300 mg vs placebo in relieving OA pain in the target knee.
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
- •Weight ≥ 50 kg and a body mass index (BMI) between 18 -35 kg/m2, at Screening 1
- •Kellgren-Lawrence grade 2 to 4 in the tibio-femoral compartment in the target knee confirmed by radiography in standing weight-bearing fixed flexion position and posterior-anterior view, at Screening 1
- •Radiographic medial joint space narrowing (mJSN) 1-2 within the medial tibio-femoral compartment of the target knee, confirmed by Xray at Screening 1
- •Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee for the majority of days in the last 3 months prior to Screening 1, as per participant’s judgement
- •Symptomatic OA with moderate to severe pain (corresponding to Pain NRS ≥ 5 to ≤ 9) in the target knee at Screening 1 and
- •Moderate to severe OA pain (corresponding to Pain NRS ≥5 to ≤9) in the target knee during the last 7 days prior to Screening 3, confirmed by: • Completed pain diary for at least 6 of the last 7 days prior to Screening 3, AND • Diary reported Pain NRS ≥5 to ≤9 for at least 6 of the last 7 days prior to Screening 3
- •KOOS pain subscale ≤ 60 in the target knee at Screening 1, Screening 2, and Screening 3
排除标准
- •Painful ipsilateral hip OA defined as a Pain NRS ≥3 on the majority of days in the last 3 months prior to Screening 1, as reported by the patient.
- •Symptomatic, patello-femoral pain in the target knee as per investigator’s examination at Screening
- •Severe malalignment > 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening
- •Patient unable or unwilling to undergo MRI or presenting absolute contraindications to MRI.
- •Previous exposure to any ADAMTS-5 drug, including QUC398
- •History or current diagnosis of relevant cardiovascular diseases and ECG abnormalities.
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 cartilage volume of the knee index region at Week 52, as determined from the automated segmentation of 3D-MRI scans
- Change from baseline in KOOS Pain subscale at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Change from baseline in pain assessed by a Pain Numerical Rating Scale (NRS) at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Change from baseline in total KOOS at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Change from baseline in KOOS subscales: Other symptoms, Function in daily living, Function in sport and recreation, and Knee related quality of life at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Change from baseline in Patient's Global Assessment (PGA) as assessed by NRS at Weeks 1 (Day 5), 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, and 52
- Systemic and local Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs, Electrocardiogram parameters (ECGs), Vital signs
- Laboratory tests (Hematology, blood chemistry, coagulation and urinalysis)
- Echo-Doppler of thoracic and abdominal aorta
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (10)
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