A study of PRA023 in patients with Crohn's Disease

Phase 1

• Conditions: Crohn's Disease; MedDRA version: 20.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

• Registration Number: EUCTR2021-000092-37-BE
• Lead Sponsor: Prometheus Biosciences, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2021-09-13
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

- Male or female = 18 years of age.
- A diagnosis of CD (confirmed by endoscopy + histology).
- Moderately to severely active CD as defined by CDAI of = 220 and = 450.
- SES-CD score = 6 if ileocolonic or colonic disease; or = 4 if isolated ileal disease only.
- Subjects must have had insufficient response and/or intolerance to conventional therapy.
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 40
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

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 on enrollment or prior to Day 1
- Diagnosis of ulcerative colitis or indeterminate colitis
- CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or ileal involvement
- Suspected or diagnosed intra-abdominal or perianal abscess at Screening
- Known symptomatic stricture or stenosis not passable in endoscopy (including pediatric colonoscope)
- Current stoma or need for colostomy or ileostomy
- Previous small bowel resection with combined resected length of > 100 cm or previous colonic resection of > 2 segments
- Currently receiving total parenteral nutrition
- Surgical bowel resection within 3 months before screening
- Concomitant PSC
- Prior exposure to PRA023
- Prisoners or subjects who are compulsorily detained (involuntarily incarcerated) for treatment of either a psychiatric or physical (e.g., infectious disease) illness
- 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