NL-OMON52134已完成2 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
- 2 期
- 状态
- 已完成
- 入组人数
- 5
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
- 18 至 99（—）
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 known
- •celiac disease alleles (typically 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
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
- •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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