A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery

Stopped early · Phase 2 · Has a placebo group

Conditions studied: Crohn Disease

In brief

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.

Key facts

Study ID

NCT03943446

Run by

Takeda

People needed

34

Starts

2020-08-04

Expected to finish

2022-08-25

Last updated by the study team

2023-09-07

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Must have a documented diagnosis of CD confirmed by endoscopic biopsy before resection or by tissue obtained at resection.
• 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.
• 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.
• Has resumed oral intake and is capable of swallowing tablets within 72 hours after surgery.

You may not qualify if…

• 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 as documented in the surgeon's operative report.
• 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.
• 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).
• 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.

Where it is running

• University of Arkansas for Medical Sciences — Little Rock, Arkansas, United States
• Cedars-Sinai Medical Center — Los Angeles, California, United States
• Hoag Memorial Hospital Presbyterian — Los Angeles, California, United States
• University of Colorado Hospital Anschutz Cancer Pavilion — Aurora, Colorado, United States
• Mayo Clinic - Jacksonville — Jacksonville, Florida, United States
• University of Miami Leonard M. Miller School of Medicine — Miami, Florida, United States
• University of South Florida/USF Health — Tampa, Florida, United States
• Atlanta Gastroenterology Associates — Atlanta, Georgia, United States
• Northwestern University — Chicago, Illinois, United States
• The University of Chicago Medical Center — Chicago, Illinois, United States
• University of Kentucky Chandler Medical Center — Lexington, Kentucky, United States
• Johns Hopkins University — Baltimore, Maryland, United States
• Massachusetts General Hospital — Boston, Massachusetts, United States
• Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States
• NYU Langone Inflammatory Bowel Disease Center — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• Columbia University Irving Medical Center — New York, New York, United States
• University of North Carolina School of Medicine — Chapel Hill, North Carolina, United States
• Atrium Health — Charlotte, North Carolina, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Vanderbilt Inflammatory Bowel Disease Clinic — Nashville, Tennessee, United States
• Houston Methodist Hospital — Houston, Texas, United States
• Allgemeines Krankenhaus Wien — Vienna, State of Vienna, Austria
• Medizinische Universitat Innsbruck — Innsbruck, Tyrol, Austria

Full record on ClinicalTrials.gov

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