TAK-018 for Prevention of the Recurrence of Postoperative Crohn's Disease (CD)
Purpose
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.
Condition
- Crohn Disease
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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 after surgery.
Exclusion Criteria
- 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.
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Prevention
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
Little Rock, Arkansas 72205
Miami, Florida 33136
Atlanta, Georgia 30342
Boston, Massachusetts 02114
Lebanon, New Hampshire 03756
New York, New York 10016
New York, New York 10029
Chapel Hill, North Carolina 27599
Houston, Texas 77030
More Details
- NCT ID
- NCT03943446
- Status
- Recruiting
- Sponsor
- Millennium Pharmaceuticals, Inc.
Detailed 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.