JPRN-jRCT2071210034已完成2 期
Phase 2 clinical trial evaluating the efficacy and safety of ART-648 in patients with bullous pemphigoid
agabukuro Hiroshi0 个研究点目标入组 30 人开始时间: 2021年6月17日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
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
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) All sexes, 20 years old and older
- •2)Patients with mild to moderate bullous pemphigoid (BP) who meet the following 1 or 2
- •1 Patients satisfied with one or all items of A and both B-1 and B-2- (2) and distinguished from the diseases listed in C.
- •2 Patients satisfied with one or all items of A, two of B-2, and distinguished from the diseases listed in C.
- •A: Clincal diagnosis
- •1. Cutaneous tense bullae and erosions
- •2. Cutaneous itchy erythema on the skin
- •B: Laboratory diagnosis
- •1. Histopathology
- •(1) Subepidermal blisters are observed
- •2. Immunology
- •(1) IgG or complement deposits are observed on the basement membrane of the epidermis of the skin by the direct fluorescent antibody method.
- •(2) Detect anti-BP180 antibody (IgG) in blood by ELISA (CLEIA) method
- •C: Differential diagnosis
- •Differentiate from the following diseases. Mucosal pemphigoid, acquired epidermolysis bullosa, epidermolysis bullosa, insect bites, urticaria-like vasculitis, porphyria, erythema multiforme, drug eruption, amyloid-sis, blistering erythematosus
- •3) Patients with a total BPDAI score in the range of 10-40 at screening
- •4) Patients who are judged by the investigator to be able to visit the hospital according to the examination/observation schedule and carry out examination/evaluation of the clinical trial, including observation of the skin condition of the whole body.
- •5) Patients who understand the method and compliance items of this clinical trial and voluntarily agree to the participation in this clinical trial with written consent.
排除标准
- •1) Patients with clinically significant medical condition, mental condition, or medical history which the investigator judges to interfere the subject's ability to participate in the clinical trial or determines that participation in the clinical trial increases the risk of the subject.
- •2) Patients with BP resistant to oral steroid or IVIG therapy
- •3) Patients with suspected drug-induced BP
- •4) Patients with prior treatment for immunosuppressants, IVIG, plasmapheresis or steroid pulse therapy
- •5) Patients with skin diseases that interfere with the evaluation of BP
- •6) Patients with a history of prior treatment with prohibited drugs within the prescribed period before the start of study drug administration
- •7) Patients who have been previously treated with biologics and have not passed more than 5 times the T1 / 2 period of the drug used at screening.
- •8) Patients who participated in other clinical trials (excluding observational studies)
- •9) Patients who disagree with contraception
- •10) Pregnant or lactating female patients
- •11) Patients who are judged by the investigator to be not eligible for the clinical trial
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