EUCTR2017-002350-36-ES进行中（未招募）1 期
A PHASE II, RANDOMIZED, PARALLEL-GROUP, DOUBLE-BLIND, DOUBLE-DUMMY, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY, SAFETY, AND PHARMACOKINETICS OF UTTR1147A COMPARED WITH PLACEBO AND COMPARED WITH VEDOLIZUMAB IN PATIENTS WITH MODERATE TO SEVERE ULCERATIVE COLITIS
Roche Farma, S.A por delegación de Genentech, Inc.0 个研究点目标入组 330 人开始时间: 2018年6月6日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 330
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
- •- Age 18-80 years
- •- Diagnosis of UC
- •- Moderate to severely active UC, defined by the Mayo Clinic Score
- •- Inadequate response, loss of response, or intolerance to prior immunosuppressant treatment and and/or corticosteroid treatment
- •- Use of highly effective contraception as defined by the protocol
- •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 300
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 30
排除标准
- •- History of psoriasis or psoriatic arthritis; any other inflammatory skin disorders requiring oral corticosteroids, immunosuppressants, or biological therapy within the previous year and primary sclerosing cholangitis
- •- History of cancer as defined by the protocol
- •- Significant uncontrolled comorbidity, such as cardiac, pulmonary, renal, hepatic, endocrine, or GI disorders (excluding UC)
- •- Prior extensive colonic resection, subtotal or total colectomy, or proctocolectomy, or planned surgery for UC
- •- Diagnosis of indeterminate colitis or granulomatous (Crohn's) colitis and toxic megacolon within 12 months prior to screening
- •- Suspicion of ischemic colitis, radiation colitis, or microscopic colitis
- •- Current fistula or history of fistula, current pericolonic abscess and Stricture (stenosis) of the colon
- •- History or current evidence of unresectable colonic mucosal dysplasia and high-grade colonic mucosal dysplasia
- •- Prior treatment with vedolizumab, etrolizumab, natalizumab, efalizumab, or any other anti-integrin agents and rituximab
- •- Use of prohibited therapies as defined by the protocol prior to randomization
- •- Evidence or treatment of infections or history of infections as defined by the protocol
研究者
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