A Randomized Double-Blind Placebo-Controlled. Multi-center Proof-of-Mechanism Phase 2a Study to Evaluate the Safety Tolerability and efficacy of TAK-018 (EB8018) for the Prevention of Post-Operative Crohn s Disease Recurrence.

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Crohn’s Disease
  • Age: Between 18 years - 150 years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Participants are capable of understanding and complying with protocol requirements
    2. Participants who provide written informed consent form
    3. Must have a documented diagnosis of Crohn’s disease (CD) confirmed by endoscopic biopsy before resection or by tissue obtained at resection
    4. Plans to undergo a laparoscopic ileocecal resection with primary anastomosis
    5. Participants has postoperative discontinuation of all concomitant medications specifically related to the treatment of CD
    6. Those who have resumed oral intake and is capable of swallowing
    7. Child bearing potential female participants and male participants who agree to take contraceptive methods during the entire study treatment period and through 100 days after the last dose of study drug

You may not be eligible for this study if the following are true:

    1. Has active perianal CD
    2. Had >3 previous surgical procedures for CD.
    3. Has macroscopically active CD that was not resected at the time of surgery
    4. Has small bowel resection that exceeds 100 cm or a subject who is considered at risk of short bowel syndrome by the surgeon or investigator
    5. Has any significant intraoperative or postoperative complications such as anastomotic leak, surgical site infection, or inability to tolerate oral intake
    6. Unable or unwilling to undergo or has contraindications to ileocolonoscopic procedures as assessed by the investigator
    7. Has inadequate renal or hepatic function postsurgery and before randomization
    8. Participants with any unstable or uncontrolled cardiovascular, pulmonary, hepatic, renal, genitourinary, coagulation, immunological, endocrine/metabolic, neurologic, active substance abuse, psychiatric or other medical disorder not related to the subject’s primary disease
    9. Active or latent tuberculosis
    10. Has chronic hepatitis B or hepatitis C infection
    11. Has a history of HIV or tests positive for HIV at screening
    12. Pregnant, lactating or breastfeeding, or intending to become pregnant If male, the subject intends to donate sperm during this study or for 100 days thereafter.
    13. Diagnosis of biliary obstruction
    14. Drug abuse or alcohol abuse
    15. Hypersensitivity or allergies to TAK-018
    16. Participated in another clinical study within the past 30 days before completing informed consent.

If you are registered as a volunteer, please log in to contact the study team/express interest in this study.