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 - CQUC398A12201

ovartis Pharma AG0 个研究点目标入组 98 人开始时间: 2024年4月10日最近更新: 2024年7月22日

研究概览

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•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 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

•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.

发起方