EUCTR2020-000649-16-ES进行中（未招募）1 期
A Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of PRV-015 in Adult Patients with Non-Responsive Celiac Disease as an Adjunct to a Gluten-free Diet - PROACTIVE (PROvention-Amgen Celiac protecTIVE study)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •Adult male or females, 18-70 years of age
- •A diagnosis of celiac disease by intestinal biopsy
- •Following a GFD for at least 12 consecutive months
- •Must have detectable (above the lower limit of detection) serum celiac-related antibodies
- •Must have human leukocyte antigen DQ (HLA-DQ) typing consistent with celiac disease (DQ2 and/or DQ8)
- •Subjects must have had at least one of the following symptoms at least once per week during the month before screening: diarrhea, loose stools, abdominal pain, abdominal cramping, bloating, or gas.
- •Body weight between 35 and 120 kg
- •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 200
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Current diagnosis of any severe complication of celiac disease, such as refractory celiac disease type 1 (RCD-I) or RCD-II, enteropathy-associated T-cell lymphoma (EATL), ulcerative jejunitis, or gastrointestinal (GI) perforation
- •Diagnosis of any chronic, active GI disease other than celiac disease
- •Presence of any active infection
- •Selective immunoglobulin A (IgA) deficiency, defined as having undetectable levels of IgA
- •Known or suspected exposure to coronavirus disease 2019 (COVID-19) infection in the 4 weeks before screening
- •Administration of a live vaccine within 14 days prior to randomization and the first administration of study drug
- •History or presence of any clinically significant disease that, in the opinion of the Investigator, may confound the subject's participation and follow-up in the clinical trial or put the subject at unnecessary risk
- •Females who are pregnant or planning to become pregnant during the study period, or who are currently breastfeeding
研究者
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