EUCTR2021-002795-39-NO进行中（未招募）1 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
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 98
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
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 width (mJSW) of 2 to 4 mm in men or 1.5 to 3.5 mm in women measured at the X=0.225 fixed point location within the medial tibio-femoral compartment of the target knee 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 2.
- •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.
- •Additional protocol specified criteria may apply.
- •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 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 18
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 1.
- •Severe malalignment > 7.5º in the target knee (either varus or valgus), measured using standardized knee X-ray at Screening 1.
- •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.
- •Additional protocol specified criteria may apply.
研究者
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