A Phase 2a Safety and Efficacy Open-Label Study of PRA023 in Subjects With Moderately to Severely Active Crohn's Disease

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to assess the safety and efficacy of PRA023 in participants with moderately to severely active Crohn's Disease.

After the completion of the 12-week induction period, all participants have the option to continue in the open-label extension for another 38 weeks.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prometheus Biosciences, Inc.

Criteria

Inclusion Criteria:

• Confirmed diagnosis of Crohn's disease

• Moderately to severely active CD as defined by Crohn's disease activity index (CDAI) score and centrally read endoscopy

• Must have corticosteroid dependence or have had no response, insufficient response, loss of response and/or intolerance to at least one of the following therapies: corticosteroid, immunosuppressants, or an approved anti-tumor necrosis factor (TNF), anti-integrin, or anti-interleukin (IL)12/23

• Able to provide written informed consent and understand and comply with the requirements of the study

Exclusion Criteria:

• Women of child bearing potential (WOCBP) and men with female partner of childbearing potential who are unwilling to use two highly effective methods of contraception to avoid pregnancy for the entire study period and up to 12 weeks after the last dose of study drug

• Diagnosis of ulcerative colitis (UC) or indeterminate colitis

• CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and/or illeal involvement

• Suspected or diagnosed intra-abdominal or perianal abscess at screening

• Current stoma or need for colostomy or ileostomy

• Previous small bowel resection with a combined resected length of >100 cm or previous colonic resection of > 2 segments

• Surgical bowel resection within 3 months before screening

• Past or current evidence of definite low-grade or high-grade colonic dysplasia not completely removed

• Subjects in the opinion of the investigator are at an unacceptable risk for participation in the study

• Subjects who meet the protocol criteria for important laboratory exclusion criteria