EUCTR2020-004382-39-CZ进行中（未招募）1 期
An Open-label Extension to the Phase 2 Randomized, Double-blind, Placebo-controlled, Crossover Multicenter Study to Evaluate the Safety and Efficacy of KZR-616 in the Treatment of Patients with Active Polymyositis or Dermatomyositis .
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
入排标准
- 性别
- All
入选标准
- •1. Must have successfully completed Study KZR-616-003 through Week 32, including the Week 32
- •Visit assessments, be willing and able to provide written informed consent prior to any study-related
- •procedures, and be willing and able to comply with study requirements.
- •2. Women of childbearing potential (WOCBP) must have a negative urine or serum pregnancy test
- •prior to the first dose of KZR-616 in Study KZR-616-003E, and must agree to continue to use a
- •highly effective method of birth control until completion of the study (or 30 days following the last
- •dose of KZR-616 in case of early withdrawal). Women of childbearing potential are defined as
- •postpubescent female patients, unless the patient is postmenopausal (defined by amenorrhea for at
- •least 2 years or amenorrhea for at least 1 year with confirmatory follicle stimulating hormone [FSH]
- •level in the postmenopausal range, as documented historically or measured by the central or local
- •laboratory and if patient is not on supplementary hormonal therapy) or surgically sterile (ie, tubal
- •ligation, hysterectomy, bilateral salpingoophorectomy).
- •3. Male patients must continue to use an effective contraception method (eg, condom with spermicide) for 1 week following their last dose of KZR-616 or be congenitally or surgically sterile (eg,
- •vasectomy with documented confirmation of post-surgical aspermia).
- •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. Have clinical evidence of significant unstable or uncontrolled diseases other than the disease under
- •study (eg, cardiac [including congestive heart failure, hypertension, angina, or myocardial
- •infarction], pulmonary [including pulmonary hypertension or interstitial lung disease], hematologic,
- •gastrointestinal, endocrinologic, hepatic, renal, neurological, or infectious disease, any ongoing
- •SAE(s), or AE(s) = Grade 3 by National Cancer Institute Common Terminology Criteria for Adverse
- •Events [NCI-CTCAE]) that, in the opinion of the Investigator or Sponsor/designee, could confound
- •the results of the study, put the patient at undue risk, or interfere with protocol adherence.
- •2. Has participated in any clinical study other than KZR-616-003 between the Week 32 Visit of Study
- •KZR-616-003 and the first study visit of KZR-616-003E, if they are not on the same calendar day.
- •3. Are females who are breastfeeding or who plan to become pregnant during the study, or who are
- •actively trying to conceive at the time of signing of the informed consent form (ICF).
- •4. Have hypersensitivity to KZR-616 or any of its excipients.
研究者
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