A Phase 2, Multi-Center, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of Induction Therapy with PRA023 in Subjects with Moderately to Severely Active Ulcerative Colitis

Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.0 个研究点目标入组 183 人开始时间: 2021年7月27日最近更新: 2024年6月3日

试验速览

暂无简介。

•Subjects are required to meet the following criteria in order to be included in the study:
•- Male or female =18 years of age
•- Subjects must have had a diagnosis of UC at least 3 months before Randomization (confirmed by endoscopy + histology) to be eligible for study participation
•- Moderately to severely active UC
•- Subjects must have had insufficient response and/or intolerance to conventional therapy
•- For subjects who are women of childbearing potential (WOCBP) involved in any sexual intercourse that could lead to pregnancy, the subject has used two highly effective methods of contraception for at least 4 weeks prior to Day 1 and agrees to continue to use two highly effective methods of contraception until at least 12 weeks after the last dose of study drug
•- Male subjects must use, with their female partner of childbearing potential, two highly effective methods of contraception and refrain from sperm donation from screening to 12 weeks after the last dose of study drug
•- Subject must meet concomitant medication stabilization requirements, as applicable
•- Able to provide written informed consent and understand and comply with the requirements of the study
•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 146
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 37

•- WOCBP and men with WOCBP partner unwilling/ unable to use two highly effective methods of contraception
•- Women who are pregnant or breastfeeding
•- Women with a positive pregnancy test
•- Diagnosis of Crohn's disease or indeterminate colitis
•- UC limited to the rectum (<15 cm from anal verge)
•- Current evidence of fulminant colitis, toxic megacolon, or bowel perforation
•- Current or impending need for colostomy or ileostomy
•- Previous total proctocolectomy or partial colectomy
•- Surgical bowel resection within 3 months before screening
•- Concomitant primary sclerosing cholangitis (PSC)
•- Past or current evidence of colonic dysplasia that has not been completely removed
•- Scheduled or anticipate the need for surgery, except dermatologic procedures
•- History of clinically significant drug or alcohol abuse
•- Prior exposure to PRA023
•- Prisoners or subjects who are compulsorily detained for treatment of either a psychiatric or physical illness must not be enrolled into this study
•- Legal or mental incapacitation, or inability to understand and comply with the requirements of the study

发起方

Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.