EUCTR2019-002605-22-DE进行中（未招募）1 期
A Phase 2 Randomized, Double-blind, Placebo-controlled,Crossover Multicenter Study to Evaluate the Safety and Efficacy ofKZR-616 in the Treatment of Patients with Active Polymyositis orDermatomyositis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 24
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
- •1. 18 years of age at the time of signing informed consent at Screening
- •2. Body Mass Index (BMI) of 18 to 40 kg/m x m
- •3. Diagnosis of probable or definite DM or PM by the 2017 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria
- •4. Must have their data reviewed by an adjudication committee to confirm eligibility unless at least 1 of the following is present:
- •a. Muscle biopsy with evidence of active myositis within the last 6 months prior to or at Screening
- •b. Electromyography or magnetic resonance imaging (MRI) with evidence of active myositis within the last 6 months prior to Screening
- •c. A CK =4 × upper limit of normal (ULN).
- •5. Must have demonstrable muscle weakness as measured by the MMT-8 with a score =80/150 but =136/150 units and any 2 of the following:
- •a. MDGA visual analog scale (VAS) =2 cm
- •b. PtGADA VAS =2 cm
- •c. At least one muscle enzyme laboratory measurement (ie, CK, aldolase, LDH) =1.3 × ULN
- •d. MDAAT Extramuscular Global Activity VAS =1 cm.
- •6. Documented inadequate response to a 12-week trial of corticosteroids or at least 1 immunosuppressant (eg, methotrexate [MTX], mycophenolate mofetil [MMF], mycophenolate sodium [MPS], azathioprine [AZA], leflunomide [LEF], tacrolimus, cyclosporine [CyA]) OR have demonstrated significant
- •documented toxicity or intolerance to such therapies
- •7. Has had age-appropriate cancer screening that is up to date and negative for evidence of malignancy as per local standard of care
- •8. Female patients of childbearing potential must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline and must agree to employ adequate birth control measures for the duration of the study.
- •9. Male patients with a partner of childbearing potential must be either congenitally sterile or surgically sterile (by vasectomy) or willing to use a condom in addition to having their female partner use another form of contraception (such as an intrauterine device, barrier method with spermicide, or hormonal contraceptive [eg, implant, injectable, patch, or oral]) from Screening until 12 weeks after the last dose of study drug, unless their partners are infertile or surgically sterile
- •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 18
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •1. Has significant muscle damage (eg, severe muscle atrophy, end-stage disease, postmyopathic DM) per Investigator opinion or has a muscle damage VAS score =5 cm on the MDI
- •2. Any other form of myositis or myopathy other than PM or DM (eg, metabolic or drug-induced myopathy, drug-induced myositis, juvenile PM or DM, inclusion body myositis, cancer-associated myositis [myositis diagnosed within 3 years, either before or after, of a diagnosis of any malignancy except for squamous or basal cell carcinoma of the skin or cervical carcinoma in situ], myositis in
- •overlap with another connective disease [eg, systemic lupus erythematosus{SLE}, systemic sclerosis,
- •rheumatoid arthritis {RA}], or muscular dystrophy); patients with secondary Sjogren’s syndrome, necrotizing myopathy, or antisynthetase syndrome are permitted to participate in this study
- •3. Any condition (eg, severe arthritis with limited range of motion or severe calcinosis) that, in the Investigator’s opinion, precludes the ability to quantitate muscle strength
- •4. Has severe interstitial lung disease per Investigator opinion or has a pulmonary damage VAS score =5 cm on the MDI
- •5. Presence of autoinflammatory disease (eg, psoriatic arthritis, axial spondyloarthropathy, inflammatory bowel disease)
- •Nota Bene: Exclusion Criteria one to five are listed. Exclusion criteria six to twenty are listed in the protocol (28May2021) from page 8-11.
研究者
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