EUCTR2017-002350-36-DE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
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 270
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 243
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 27
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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