TAK-018 for Prevention of the Recurrence of Postoperative Crohn’s Dise
Research type
Research Study
Full title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Phase 2a Study to Evaluate the Safety, Tolerability, and Early Proof of Concept of TAK-018 for the Prevention of Postoperative Crohn’s Disease Recurrence
IRAS ID
266345
Contact name
Ailsa Hart
Contact email
Sponsor organisation
Takeda Development Center, Americas, Inc.
Eudract number
2019-000886-19
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
U1111-1225-5064, WHO Universal Trial Number (UTN); 137694, IND Number
Duration of Study in the UK
1 years, 8 months, 0 days
Research summary
Crohn’s disease (CD) is a chronic, relapsing inflammatory disease of the gastrointestinal tract with no known cure. Its incidence globally is on the rise, reaching 20 per 100,000 person-years in Western countries. Up to 60% of patients with CD will require surgery to remove part of the bowel (resection) within 10 years of their diagnosis, and a majority of them will develop postoperative recurrence within 1 year after surgery.
A number of factors are involved in causing CD; genetics, an imbalance in the types of bacteria living inside the bowel, and the patient’s inflammatory response.
Bacteria may trigger and sustain the ongoing inflammation and bowel wall damage seen in CD. TAK-018 works by blocking a type of bacteria that enters the bowel wall. This is a unique mechanism of action for treatment of CD. Most current CD therapies (such as steroids, immunosuppressants and biological medicines) have yielded either negative or equivocal results in terms of preventing relapse, and their use may result in suppression of the immune system. TAK-018 may allow patients with CD to maintain remission without lifelong immune suppression.
The main purpose of this study is to evaluate how safe and well-tolerated TAK-018 is in participants with CD after bowel resection. The study will also look at whether TAK-018 can stop CD from recurring after surgery.
Participants may be involved in the study for up to 34 weeks. This includes a screening period of 30 days, treatment period of 12 weeks and follow-up period of 18 weeks. There will be about 45 to 75 volunteers taking part in this study at approximately 30 study clinics in North America and Europe.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
19/NE/0287
Date of REC Opinion
6 Nov 2019
REC opinion
Further Information Favourable Opinion