CTIS2023-504265-23-00招募中1 期
A PHASE 2, MULTI-CENTER, DOUBLE-BLIND, TWO-ARM STUDY OF SUBCUTANEOUS RVT-3101 FOR THE TREATMENT OF SUBJECTS WITH MODERATE TO SEVERE ACTIVE CROHN’S DISEASE - RVT-3101-201
Telavant Inc.0 个研究点目标入组 113 人开始时间: 2023年6月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 113
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 65+（—）
- 性别
- All
入选标准
- •Written informed consent, according to local guidelines, signed and dated by the participant prior to the performance of any study-specific procedures, sampling, or analysis., Participants of any gender-definition, aged 18-75 years (or at age of consent per local guidelines if =18 years)., Must have confirmed diagnosis of ileal, ileocolonic or colonic CD for at least 12 weeks (approximately 3 months) prior to the Baseline (W1, D1) Visit. Appropriate documentation of biopsy-proven CD must be available and recorded., CDAI score 220-450 determined at Screening, CDAI to be assessed prior to Screening colonoscopy.
排除标准
- •Diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis or active diverticular disease., For prohibited medications and exceptions please see Section 8.7 of the protocol., Presence of an ostomy or ileoanal pouch., Bowel resection or diversion within approximately 6 months prior to the Baseline (W1, D1) Visit.
研究者
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