A Phase 2a Safety and Efficacy Open-Label Study of Tulisokibart (MK-7240/PRA023) in Participants With Moderately to Severely Active Crohn's Disease (MK-7240-006)
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Confirmed diagnosis of Crohn's disease (CD)
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
You may not be if
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
Participants in the opinion of the investigator are at an unacceptable risk for participation in the study
