EUCTR2016-000420-26-PL进行中（未招募）1 期
A MULTICENTER, SUBJECT-BLIND, INVESTIGATOR-BLIND, RANDOMIZED, PLACEBO-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY, TOLERABILITY, AND PHARMACOKINETICS OF AN IV LOADING DOSE FOLLOWED BY SC ADMINISTRATION OF BIMEKIZUMAB (UCB4940) IN SUBJECTS WITH MODERATE TO SEVERE ACTIVE ULCERATIVE COLITIS
CB Biopharma SPR0 个研究点目标入组 60 人开始时间: 2017年2月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
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
- •-Subject has a diagnosis of Ulcerative Colitis (UC) confirmed (at least 90 days prior to Visit 1a) by clinical, endoscopic, and histologic evidence
- •- Subject has a Mayo endoscopy subscore >=2
- •- Subject has a Mayo rectal bleeding subscore >=1
- •- Subject has moderate to severe active UC - Total Mayo score 6 to 12 within 10 (±4) days prior to Visit 2 (Week 0)
- •- Subject has responded inadequately to convention therapy for UC
- •- Subjets may have received treamtment with 1 biological therapy or a calcineurin inhibitor
- •- Woman with childbearing potential must be either postmenopausal, permanently sterilized or willing
- •to use at least 1 highly effective method of contraception in addition to a barrier method
- •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 50
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •- Subject who has had a resective colonic surgery, or has an ostomy or ileoanal pouch or is planning any resection while enrolled in the study
- •- Subject with current diagnosis of Crohn´s Disease (CD) or indeterminant colitis or acute diverticulitis based on medical history
- •- Subject has an extension of disease limited to ulcerative proctitis (disease extension) <15cm from the anal verge
- •- Subject requiring immediate surgical, endoscopic or radiological intervention due to toxic megacolo intraabdominal or perianal abscess
研究者
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已完成
不适用
A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT-BLIND, ADAPTIVE SINGLE-ASCENDING-DOSE (SAD), PLACEBO-CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY, PHARMACOKINETICS (INCLUDING THE EFFECT OF FOOD AND THE EFFECT OF ITRACONAZOLE ON THE PHARMACOKINETICS OF A SINGLE ORAL DOSE OF RO7034067), AND PHARMACODYNAMICS OF RO7034067 FOLLOWING ORAL ADMINISTRATION IN HEALTHY SUBJECTSNL-OMON42781F. Hoffmann-La Roche Ltd93