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

Study Description:

• 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.