A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
Condition: Crohn Disease
MeSH terms: Crohn Disease; Recurrence
Intervention: TAK-018; TAK-018 Placebo
Intervention description: TAK-018 immediate-release tablets.; TAK-018 placebo-matching tablets.
Phase: Phase 2
Study type: Interventional
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 34.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Drug Therapy

Summary:

      The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after
      abdominal resection surgery in adults with Crohn's disease.

      Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to
      26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it.

      Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be
      conducted at the study clinic. The others can be in the clinic or at the participant's home.
      Follow-up will occur 4 weeks after final treatment.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection
             or by tissue obtained at resection.

          2. Planned to undergo a laparoscopic ileocecal resection with primary anastomosis within
             72 hours before randomization Day 1. Confirmation that no active disease has been left
             behind after resection will be based on surgeon's documentation in the operative
             report.

          3. With postoperative discontinuation of all concomitant medications specifically related
             to the treatment of CD. This includes anti-tumor necrosis factor-alpha (TNF-α) and
             anti-integrin therapy, anti- interleukin (IL) 12/23, thiopurines and other
             immunomodulators, steroids, 5-minosalicylates, and prophylactic use of antibiotics for
             the prevention of postoperative recurrence such as metronidazole.

          4. Has resumed oral intake and is capable of swallowing tablets within 72 hours after
             surgery.

        Exclusion Criteria:

          1. Has active perianal CD.

          2. Has had >3 previous surgical procedures for CD.

          3. Has macroscopically active CD that was not resected at the time of surgery as
             documented in the surgeon's operative report.

          4. With small bowel resection that exceeds 100 centimeter (cm) or a participant who is
             considered at risk of short bowel syndrome by the surgeon or investigator.

          5. Has active or latent tuberculosis, regardless of treatment history, as evidenced by
             any of the following: history of tuberculosis, OR positive QuantiFERON test or 2
             successive indeterminate QuantiFERON tests, OR a tuberculin skin test reaction ≥10
             millimeter (mm) (≥5 mm in participants receiving the equivalent of >15 milligram per
             day (mg/day) prednisone).

          6. Has chronic hepatitis B (hepatitis B surface antigen positive, or positive for both
             hepatitis B surface antibody and hepatitis B core antibody but negative for hepatitis
             B surface antigen) or hepatitis C infection (evident by viral replication by
             polymerase chain reaction) within 30 days of randomization.