EUCTR2020-002306-12-PL进行中（未招募）1 期
A Phase 2, randomized, double-blind, placebo-controlled, multi-center study to evaluate GB004 in adult subjects with mild-to-moderate active ulcerative colitis
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GB004, Inc.
- 入组人数
- 195
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
- •o Adult male and female subjects aged = 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
- •o UC diagnosed at least 3 months prior to first dose of investigational product (IP) on Day 1.
- •o Currently receiving treatment for UC, on a stable dose for at least 2 weeks prior to flexible sigmoidoscopy or colonoscopy, with oral 5-ASA (eg, mesalamine, sulfasalazine) alone or with one of the following treatments:
- •a. prednisone = 20 mg/day or equivalent or
- •b. beclomethasone = 5 mg/day or
- •c. budesonide or budesonide multi-matrix (MMX) of = 9 mg/day
- •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 195
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •o Prior approved biologic therapy used for the treatment of UC.
- •o Evidence of Crohn's disease, indeterminate colitis, or presence of bacterial or parasitic infection.
- •o Tofacitinib, oral cyclosporine, sirolimus or myocophenolate mofetil within 8 weeks of Day 1.
- •o Azathioprine, or 6-mercaptopurine within 1 day of Day 1.
- •o Diagnosis of Crohn's disease or indeterminate colitis, pouchitis.
研究者
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