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 - NA

GENENTECH, INC.0 个研究点目标入组 195 人开始时间: 2021年1月22日最近更新: 2024年3月12日

适应症

试验速览

暂无简介。

•- 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

•- 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

发起方