A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
NCT ID: NCT03943446
Last Updated: 2023-09-07
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
34 participants
INTERVENTIONAL
2020-08-04
2022-08-25
Brief Summary
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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.
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Detailed Description
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The study will enroll approximately 96 participants. Participants will be randomly assigned (by chance, like flipping a coin) in 1:1:1 ratio to one of the three treatment groups-which will remain undisclosed to the participants and study doctor during the study (unless there is an urgent medical need):
* TAK-018 0.30 g Low dose
* TAK-018 1.5 g High dose
* Placebo
All participants will be asked to take the tablets twice daily immediately after a meal (that is, breakfast and dinner) with water, approximately 8 to 12 hours apart.
Participants will have flexibility to either to opt for home health care (HHC) solutions at Screening, Week 3, Week 6, Week 12, Week 18 and Week 30 or travel to the clinic for all scheduled visits per protocol as permitted by local regulations. This flexible approach is designed in response to health care delivery challenges presented by the coronavirus disease (COVID-19) pandemic and to provide additional flexibility during the course of the trial. Assessments after surgery and endoscopy at Week 26 will be conducted at the clinic. All other study visits may be conducted by telehealth and home health care (HHC).
This multi-center trial will be conducted in the United States, United Kingdom, France, Austria and Germany. The overall time to participate in this study is approximately 34 weeks. Participants will make final visit to the clinic or can opt for HHC visit at Week 30 (30 days after the Week 26 endoscopy) for safety follow-up.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Placebo
TAK-018 placebo-matching tablets, orally, twice daily (BID) for up to 27.7 weeks.
TAK-018 Placebo
TAK-018 placebo-matching tablets.
TAK-018 0.30 g Low Dose
TAK-018 0.30 gram (g), tablets, orally, BID for up to 31.7 weeks.
TAK-018
TAK-018 immediate-release tablets.
TAK-018 1.5 g High Dose
TAK-018 1.5 g, tablets, orally, BID for up to 26.1 weeks.
TAK-018
TAK-018 immediate-release tablets.
Interventions
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TAK-018
TAK-018 immediate-release tablets.
TAK-018 Placebo
TAK-018 placebo-matching tablets.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Takeda
INDUSTRY
Responsible Party
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Principal Investigators
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Study Director
Role: STUDY_DIRECTOR
Takeda
Locations
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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
Medizinische Universitat Innsbruck
Innsbruck, Tyrol, Austria
Allgemeines Krankenhaus Wien
Vienna, Vienna, Austria
Les Hopitaux Universitaires de Strasbourg - Hopital Hautepierre
Strasbourg, Alsace, France
Centre Hospitalier Universitaire Estaing
Clermont-Ferrand, Auvergne, France
Hopital Pontchaillou
Rennes, Brittany Region, France
Hopital Saint-Louis
Paris, Il-de-France, France
Hopital Rangueil
Toulouse, Midi-pyrenees, France
Centre Hospitalier Universitaire de Nice Hopital l'Archet
Nice, Provence-Alpes-Côte d'Azur Region, France
Universitatsklinikum Freiburg
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Universitatsmedizin Mannheim
Mannheim, Baden-Wurttemberg, Germany
Klinikum Luneburg
Lüneburg, Lower Saxony, Germany
Evangelisches Krankenhaus Kalk
Cologne, North Rhine-Westphalia, Germany
Klinikum Sankt Georg GmbH
Leipzig, Saxony, Germany
Krankenhaus Waldfriede
Berlin, , Germany
University Hospitals Birmingham NHS Foundation Trust
Birmingham, England, United Kingdom
London North West Healthcare NHS Trust
Harrow, England, United Kingdom
Saint Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, England, United Kingdom
NHS Greater Glasgow and Clyde
Glasgow, Scotland, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain more information about this study, click this link.
Other Identifiers
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2019-000886-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1225-5064
Identifier Type: REGISTRY
Identifier Source: secondary_id
NR266345
Identifier Type: REGISTRY
Identifier Source: secondary_id
NL71098.018.19
Identifier Type: REGISTRY
Identifier Source: secondary_id
TAK-018-2001
Identifier Type: -
Identifier Source: org_study_id
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