TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD)

  • STATUS
    Recruiting
  • End date
    Oct 31, 2022
  • participants needed
    96
  • sponsor
    Millennium Pharmaceuticals, Inc.
Updated on 28 August 2021
antibiotic therapy
antibiotics
tumor necrosis factor
crohn's disease
tumor necrosis factor alpha
tumour necrosis
immunomodulators
thiopurines

Summary

The purpose of this study is to evaluate the efficacy of TAK-018 in reducing endoscopic recurrence of intestinal inflammation in postoperative participants with CD after a planned laparoscopic ileocecal resection with primary anastomosis.

Description

The drug being tested in this study is called TAK-018. 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.

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.

Details
Condition Inflammatory bowel disease, Crohn's Disease, Crohn's Disease (Pediatric), crohns disease
Treatment TAK-018, TAK-018 Placebo
Clinical Study IdentifierNCT03943446
SponsorMillennium Pharmaceuticals, Inc.
Last Modified on28 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

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-) 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 after surgery

Exclusion Criteria

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
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