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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03943446
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Takeda
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Study Director
Principal Investigator Affiliation Takeda
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Austria, France, Germany, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Crohn Disease
Study Website: View Trial Website
Additional Details

The drug being tested in this study is called TAK-018 (Sibofimloc). TAK-018 is used for the prevention of postoperative CD recurrence. This study will evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after planned laparoscopic ileocecal resection with primary anastomosis. 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.

Arms & Interventions

Arms

Experimental: TAK-018 0.30 g Low Dose

TAK-018 3*0.10 gram (g), tablets, orally, twice daily (BID) for up to 26 weeks.

Experimental: TAK-018 1.5 g High Dose

TAK-018 3*0.50 g, tablets, orally, BID for up to 26 weeks.

Placebo Comparator: Placebo

TAK-018 placebo-matching 3*0 g tablets, orally, BID for up to 26 weeks.

Interventions

Drug: - TAK-018

TAK-018 immediate-release tablets.

Drug: - TAK-018 Placebo

TAK-018 placebo-matching tablets.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Little Rock, Arkansas

Status

Recruiting

Address

University of Arkansas for Medical Sciences

Little Rock, Arkansas, 72205

Site Contact

Site Contact

sdehmel@uams.edu

501-603-1900

Cedars-Sinai Medical Center, Los Angeles, California

Status

Recruiting

Address

Cedars-Sinai Medical Center

Los Angeles, California, 90048

Site Contact

Site Contact

gil.melmed@cshs.org

310-652-8031

Hoag Memorial Hospital Presbyterian, Los Angeles, California

Status

Recruiting

Address

Hoag Memorial Hospital Presbyterian

Los Angeles, California, 92618

Site Contact

Site Contact

caroline.hwang@hoag.org

949-557-0251

Aurora, Colorado

Status

Recruiting

Address

University of Colorado Hospital Anschutz Cancer Pavilion

Aurora, Colorado, 80045

Site Contact

Site Contact

frank.i.scott@ucdenver.edu

720-848-2777

Mayo Clinic - Jacksonville, Jacksonville, Florida

Status

Recruiting

Address

Mayo Clinic - Jacksonville

Jacksonville, Florida, 32224

Site Contact

Site Contact

farraye.francis@mayo.edu

617-638-8339

Miami, Florida

Status

Recruiting

Address

University of Miami Leonard M. Miller School of Medicine

Miami, Florida, 33136

Site Contact

Site Contact

mabreu1@med.miami.edu

305-243-8644 #opt3

University of South Florida/USF Health, Tampa, Florida

Status

Recruiting

Address

University of South Florida/USF Health

Tampa, Florida, 33612

Site Contact

Site Contact

rbennet1@usf.edu

813-974-2201

Atlanta Gastroenterology Associates, Atlanta, Georgia

Status

Active, not recruiting

Address

Atlanta Gastroenterology Associates

Atlanta, Georgia, 30342

Northwestern University, Chicago, Illinois

Status

Recruiting

Address

Northwestern University

Chicago, Illinois, 60611

The University of Chicago Medical Center, Chicago, Illinois

Status

Recruiting

Address

The University of Chicago Medical Center

Chicago, Illinois, 60637

Lexington, Kentucky

Status

Recruiting

Address

University of Kentucky Chandler Medical Center

Lexington, Kentucky, 40536

Site Contact

Site Contact

drflom0@email.uky.edu

859-323-6423

Baton Rouge General Medical Center, Baton Rouge, Louisiana

Status

Not yet recruiting

Address

Baton Rouge General Medical Center

Baton Rouge, Louisiana, 70809

Site Contact

Site Contact

jchapman@tddctx.com

225-387-7077

Johns Hopkins University, Baltimore, Maryland

Status

Recruiting

Address

Johns Hopkins University

Baltimore, Maryland, 21205

Site Contact

Site Contact

joanna.peloquin@jhmi.edu

410-502-1559

Massachusetts General Hospital, Boston, Massachusetts

Status

Recruiting

Address

Massachusetts General Hospital

Boston, Massachusetts, 02114

Dartmouth-Hitchcock Medical Center, Lebanon, New Hampshire

Status

Recruiting

Address

Dartmouth-Hitchcock Medical Center

Lebanon, New Hampshire, 03756

New York, New York

Status

Recruiting

Address

NYU Langone Inflammatory Bowel Disease Center

New York, New York, 10016

Site Contact

Site Contact

jordan.axelrad@nyulangone.org

212-263-3095

Icahn School of Medicine at Mount Sinai, New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mount Sinai

New York, New York, 10029

Site Contact

Site Contact

james.marion@mssm.edu

212-861-2000

New York, New York

Status

Recruiting

Address

Columbia University Irving Medical Center

New York, New York, 10032

Site Contact

Site Contact

bs3270@cumc.columbia.edu

212-305-5664

Chapel Hill, North Carolina

Status

Recruiting

Address

University of North Carolina School of Medicine

Chapel Hill, North Carolina, 27599-7032

Site Contact

Site Contact

hherf@med.unc.edu

919-966-8946

Atrium Health, Charlotte, North Carolina

Status

Recruiting

Address

Atrium Health

Charlotte, North Carolina, 28204

Site Contact

Site Contact

lodhia@musc.edu

704-355-4593

Cleveland Clinic, Cleveland, Ohio

Status

Recruiting

Address

Cleveland Clinic

Cleveland, Ohio, 44195

Site Contact

Site Contact

philpoj@ccf.org

216-444-1711

University of Pittsburgh Medical Center, Pittsburgh, Pennsylvania

Status

Recruiting

Address

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213-2536

Site Contact

Site Contact

biniond@upmc.edu

412-648-8982

Nashville, Tennessee

Status

Recruiting

Address

Vanderbilt Inflammatory Bowel Disease Clinic

Nashville, Tennessee, 37212-1375

Site Contact

Site Contact

robin.dalal@vumc.org

615-322-0128

Houston Methodist Hospital, Houston, Texas

Status

Recruiting

Address

Houston Methodist Hospital

Houston, Texas, 77030-2740

Site Contact

Site Contact

bpabraham@houstonmethodist.org

713-790-3333

International Sites

Medizinische Universitat Innsbruck, Innsbruck, Tyrol, Austria

Status

Recruiting

Address

Medizinische Universitat Innsbruck

Innsbruck, Tyrol, 6020

Site Contact

Site Contact

robert.koch@i-med.ac.at

+43 512 504 23539

Allgemeines Krankenhaus Wien, Wien, Vienna, Austria

Status

Recruiting

Address

Allgemeines Krankenhaus Wien

Wien, Vienna, 1090

Strasbourg Cedex, Alsace, France

Status

Recruiting

Address

Les Hopitaux Universitaires de Strasbourg - Hopital Hautepierre

Strasbourg Cedex, Alsace, 67200

Centre Hospitalier Universitaire Estaing, Clermont-Ferrand Cedex, Auvergne, France

Status

Recruiting

Address

Centre Hospitalier Universitaire Estaing

Clermont-Ferrand Cedex, Auvergne, 63003

Hopital Pontchaillou, Rennes Cedex 9, Bretagne, France

Status

Recruiting

Address

Hopital Pontchaillou

Rennes Cedex 9, Bretagne, 35033

Hopital Saint-Louis, Paris Cedex 10, Il-de-France, France

Status

Recruiting

Address

Hopital Saint-Louis

Paris Cedex 10, Il-de-France, 75475

Site Contact

Site Contact

matthieu.allez@aphp.fr

+33142499597

Hopital Rangueil, Toulouse Cedex 9, Midi-pyrenees, France

Status

Recruiting

Address

Hopital Rangueil

Toulouse Cedex 9, Midi-pyrenees, 31059

Site Contact

Site Contact

gilletta.c@chu-toulouse.fr

+33 5 61 32 20 45

Nice Cedex 3, Provence Alpes Cote D'Azur, France

Status

Recruiting

Address

Centre Hospitalier Universitaire de Nice Hopital l'Archet

Nice Cedex 3, Provence Alpes Cote D'Azur, 06202

Site Contact

Site Contact

hebuterne.x@chu-nice.fr

+33 4 92 03 61 68

Universitatsklinikum Freiburg, Freiburg, Baden-Wuerttemberg, Germany

Status

Recruiting

Address

Universitatsklinikum Freiburg

Freiburg, Baden-Wuerttemberg, 79106

Universitatsmedizin Mannheim, Mannheim, Baden-Wuerttemberg, Germany

Status

Recruiting

Address

Universitatsmedizin Mannheim

Mannheim, Baden-Wuerttemberg, 68167

Site Contact

Site Contact

wolfgang.reindl@umm.de

+49 621 3833294

Klinikum Luneburg, Luneburg, Niedersachsen, Germany

Status

Recruiting

Address

Klinikum Luneburg

Luneburg, Niedersachsen, 21339

Evangelisches Krankenhaus Kalk, Koln, Nordrhein-westfalen, Germany

Status

Recruiting

Address

Evangelisches Krankenhaus Kalk

Koln, Nordrhein-westfalen, 51103

Site Contact

Site Contact

konrad.streetz@evkk.de

+4922182895289

Klinikum Sankt Georg GmbH, Leipzig, Sachsen, Germany

Status

Recruiting

Address

Klinikum Sankt Georg GmbH

Leipzig, Sachsen, 04129

Site Contact

Site Contact

ingolf.schiefke@sanktgeorg.de

+4903419092626

Krankenhaus Waldfriede, Berlin, Germany

Status

Recruiting

Address

Krankenhaus Waldfriede

Berlin, , 14163

Site Contact

Site Contact

c.buening@waldfriede.de

+493081810243

Birmingham, England, United Kingdom

Status

Recruiting

Address

University Hospitals Birmingham NHS Foundation Trust

Birmingham, England, B15 2TH

Site Contact

Site Contact

rachel.cooney@uhb.nhs.uk

+441213715879

London North West Healthcare NHS Trust, Harrow, England, United Kingdom

Status

Recruiting

Address

London North West Healthcare NHS Trust

Harrow, England, HA1 3UJ

Site Contact

Site Contact

ailsa.hart@nhs.net

+44 2088695805

London, England, United Kingdom

Status

Not yet recruiting

Address

University College London Hospitals NHS Foundation Trust

London, England, NWI 2PG

Site Contact

Site Contact

alex.vonroon@nhs.net

+44 020 3447 7059

Prescot, England, United Kingdom

Status

Recruiting

Address

Saint Helens and Knowsley Teaching Hospitals NHS Trust

Prescot, England, L35 5DR

Site Contact

Site Contact

rajiv.chandy@sthk.nhs.uk

+441514261600

NHS Greater Glasgow and Clyde, Glasgow, Scotland, United Kingdom

Status

Recruiting

Address

NHS Greater Glasgow and Clyde

Glasgow, Scotland, G51 4TF

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