2022-502821-16-00已完成2 期
A randomized, placebo controlled, investigator and participant-blinded study, investigating safety, tolerability and efficacy of RHH646 in participants with knee osteoarthritis
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 63
- 试验地点
- 12
- 主要终点
- Change from baseline in cartilage volume in the index region of the target knee by MRI at Week 52
研究概览
简要总结
- To evaluate the articular cartilage-regenerating capacity of RHH646 in the knee following 1 year of treatment
- To evaluate the safety and tolerability of RHH646 following 1 year of treatment
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
- 否
入选标准
- •Participant is >/= 35 and </=75 years old at time of screening
- •Participant must weigh at least 50 kg and have a body mass index (BMI) </= 35 kg/m2
- •Diagnosis of tibiofemoral OA in at least one knee by standard American College of Rheumatology (ACR) clinical and radiographic criteria at screening
- •K&L grade 2 to 3 OA in the target knee evaluated by X-Ray by the Central reader at screening
- •Predominantly medial tibiofemoral compartment involvement defined as medial Joint Space Narrowing (medJSN) 1-2 and medJSN > lateral Joint Space Narrowing (latJSN) in the target knee evaluated by X-Ray by the Central Reader at screening
- •Symptomatic disease, defined as having pain in the knee at least 3 days per week during the last 3 months from screening that is relieved by analgesic therapy (e.g., APAP or NSAIDs), according to the investigator’s evaluation and judgement of patient’s history
排除标准
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant
- •Inability to undergo MRI (e.g. claustrophobia, body size, leg not fitting in the coil) or contraindications to MRI (e.g. non-MRI compatible metallic implants, metallic foreign bodies, pacemaker, defibrillator)
- •Arthroscopy of the target knee within the 6 months prior to screening or planned arthroscopy during the study
- •Previous surgical treatment of the target knee using mosaicplasty, microfracture, meniscectomy >50% or osteotomy; planned surgery for either knee during the study
- •Unstable target knee joint or insufficiently reconstructed ligaments based on medical history and/or physical examination by the investigator
- •Participant has severe malalignment (valgus or varus deformity) in the target knee >7.5° based on X-Ray evaluation by the Central Reader at screening
- •K&L grade 4 OA in either knee
- •Presence of severe hip OA that either (i) alters lower limb function to a degree that increases or abnormally changes the mechanical forces in the knee while walking according to the investigator’s evaluation or (ii) currently requires or is likely to require specific medical or surgical management during the study period
- •Other pathologies affecting the knee, including subchondral insufficiency fractures, bone fracture (acute or subacute within the 6 months prior to screening) or bone bruise, osteonecrosis, malignant bone marrow infiltration, solid tumors and/or patellofemoral dysplasia bbased on clinical assessment or imaging
- •Known autoimmune disease with inflammatory arthritis, crystal-induced arthritides (gout or pseudogout arthritis), active acute or chronic infection of the knee joint, Lyme disease involving the knee, reactive arthritis, systemic cartilage disorders, moderate to severe fibromyalgia, a known systemic connective tissue disease or a widespread pain index >4
结局指标
主要结局
Change from baseline in cartilage volume in the index region of the target knee by MRI at Week 52
Change from baseline in cartilage volume in the index region of the target knee by MRI at Week 52
Adverse Events (AEs) Electrocardiograms (ECGs) Vital signs Hematology, blood chemistry, urinalysis
Adverse Events (AEs) Electrocardiograms (ECGs) Vital signs Hematology, blood chemistry, urinalysis
次要结局
- RHH646 plasma concentrations, Cmin,ss at Week4 and any other PK parameter as appropriate
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (12)
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