A study of PRA023 in patients with Ulcerative Colitis

Phase 1

• Conditions: lcerative Colitis; MedDRA version: 20.1Level: LLTClassification code 10045365Term: Ulcerative colitisSystem Organ Class: 100000004856; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-000091-11-CZ
• Lead Sponsor: Prometheus Biosciences, Inc. a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-04-22
• Last Update Posted: 26 September 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 183

Inclusion Criteria

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

Exclusion Criteria

- 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified