TAK-018 for the Prevention of Postoperative CD Recurrence
Condition: Crohn’s disease
Key Inclusion Criteria
- At least 18 years old
- Documented diagnosis of Crohn’s disease (CD) confirmed by endoscopic biopsy before resection or by tissue obtained at resection
- Planning to undergo a laparoscopic ileocecal resection with primary anastomosis within 72 hours before assignment to study group
Key Exclusion Criteria
- Has active perianal CD
- Has had >3 previous surgical procedures for CD
- Has macroscopically active CD that was not resected at the time of surgery
Full Study Name
TAK-018-2001: A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn's Disease Recurrence (IRB no. 00001016)
This study focuses on individuals with Crohn’s disease (CD) who are going to have surgery to remove part of their bowel (called “resection”). The purpose of the study is to evaluate the safety and tolerability of an investigational drug called TAK-018 in patients with CD after bowel resection. The study will also evaluate whether TAK-018 can prevent CD from recurring after surgery. TAK-018 works by blocking a type of gut bacteria that enters the bowel wall.
Participants will be randomly assigned to 1 of 3 treatment groups: One group will receive a low dose of TAK-018; another group will receive a high dose of TAK-018, and the third group will receive placebo (inactive substance).
Participants will also be asked to give tissue, blood and stool samples for biomarker research. Biomarkers found in tissue, blood, and stool may allow doctors to identify individuals who are more likely to respond to TAK-018, are responding to the drug, or may develop side effects to TAK-018.