NL-OMON52361尚未招募2 期
RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 2 STUDY OF VE202 IN PATIENTS WITH MILD-TO-MODERATE ULCERATIVE COLITIS - study research the effects of VE202 in patients with ulcerative colitis
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 29
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
- •1. Active mild to moderate UC, as defined by the following:
- •* Disease that extends at least 15 cm from the anal verge
- •* Modified Mayo score of 4 to 8
- •* Mayo endoscopic subscore as follows, based on screening flexible
- •sigmoidoscopy:
- •i. Subscore of >2 * Rectal bleeding score of >= -1
- •2. May be on corticosteroids, maximum dose of 10 mg QD prednisone (or prednisone
- •equivalent) or budesonide 9 mg QD, if dose is stable for at least 4 weeks
- •3. Other allowable medications (eg, mesalamine, 6-mercaptopurine) at a stable
- •dose for at least
- •4. Naïve to biologics - and Janus kinase inhibitor and sphingosine-1-phosphate
排除标准
- •A diagnosis of any non-IBD diarrheal illness
- •. A diagnosis of primary sclerosing cholangitis
- •Allergy to VE202 or vancomycin or any of their components
- •. Use of systemic or non-absorbable oral antibiotics within the prior 4 weeks
- •before randomization or anticipated within the study period
- •. Use of probiotics within the prior 2 weeks (consumption of yogurt and kefir
- •are permissible)
- •. Active colonic dysplasia
- •. Presence of adenomatous polyp on screening endoscopy, or history of
- •adenomatous polyps that were not removed
- •. Pregnant or lactating female
研究者
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