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
To assess the safety and tolerability and early proof of efficacy of TAK-018 in patients with Crohn’s Disease who are planning to undergo surgery to remove the diseased ileo-cecal region of the bowel.
Severity: Requiring surgery as part of disease management
- Male or female patients aged ≥18 years or local legal age at signing of informed consent
- Patient has a documented diagnosis of Crohn’s Disease confirmed by endoscopic biopsy
- Patient undergoes laparoscopic ileocecal resection within 72 hours prior to first dose
- Patient discontinues from all medications related to the treatment of Crohn’s Disease after surgery
- Patient is capable of swallowing tablets within 72 hours after surgery
- Patient must agree to contraception requirements
- Patient must not have active perianal Crohn’s Disease
- Patient has applicable safety labs within normal limit parameters
- Phase 2a
- Patients will be consented and eligibility will be confirmed.
- Study drug or placebo will be dosed within 3 days after surgery, and continued for 6 months when a colonoscopy will be performed to assess how many patients remain in remission.
- During this time there are 6 study visits and a 30 day Safety Follow Up visit.
- To assess drug safety and tolerability, clinical visits with blood and stool collections will be performed periodically in the 6 month time frame, either in-person or virtually utilizing Home Healthcare and a telemedicine virtual visit to minimize inconvenience.
- Patient related outcomes including abdominal pain and stool frequency as well as study drug compliance will be monitored using a hand held device.
Description of treatment or intervention (mechanism of action):
- TAK018 is a small molecule that has the potential to block a group of bacteria present in the gut that might be triggering inflammation seen in Crohn’s Disease.
- The site of drug action is in the lumen of the gut and very small amount of the drug enters the circulation.
- Unlike antibiotics, TAK018 does not kill bacteria or regulate the patient’s immune system.
- If successful, this will offer a novel approach to prevent disease recurrence after surgery.
- TAK-018 is a tablet which is taken orally (by mouth).
- It is being evaluated as a possible treatment for CD.
- A number of factors are involved in causing CD.
- An imbalance of the types of bacteria that live inside the gut is one of those factors.
- TAK-018 works by blocking a type of gut bacteria that enters the bowel wall.
- The bacteria then may trigger and sustain the ongoing inflammation and bowel wall damage seen in CD.
Patient Participation Requirements
- Patients should discuss the study with their doctor to review eligibility for study participation.
Possible risks and side effects:
- TAK018 is under investigation for safety and tolerability.
- To date no side effects attributable to the drug have been identified.