VECTORS – A study to evaluate transmural healing as a treatment target in Crohn’s disease
Research type
Research Study
Full title
An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients with Moderately to Severely Active Crohn’s Disease (VECTORS)
IRAS ID
1009787
Contact name
Angela Winkler
Contact email
Sponsor organisation
Alimentiv Inc.
Clinicaltrials.gov Identifier
Research summary
Researchers are investigating how treating and monitoring Crohn’s disease (CD) to meet specific treatment goals will keep the disease under control (remission) and decrease complications such as hospitalisations and surgeries.
Group 1 treatment goals include IUS response (using ultrasound to monitor whether the medication is improving CD) and IUS assessed transmural healing (using ultrasound to assess healing of all bowel layers), clinical remission (normalisation of CD symptoms), and biomarker remission (improvement in stool and blood tests that show inflammation). Group 2 treatment goals include clinical remission and biomarker remission.
Participants have a 50% chance of being assigned to 1 of 2 groups. Neither participant nor the study doctor will be able to choose which group they are assigned to. Approximately 152 people will be assigned to each group.
This study will enroll approximately 304 participants in approximately 10 countries for approximately 2 years. Participants may have up to 11 visits to the site over about 100 weeks. Visits may take from 2 to 4 hours as tests differ at each visit.
Stool, urine, blood samples and biopsy will be collected, for routine safety and study-related tests.
Participants will be asked to complete an electronic study diary, the number of questions to complete will vary each day , on some days it can take approximately 20 to 30 minutes to complete.
This study will involve participants receiving 300 mg of vedolizumab as an intravenous (IV) infusion at Weeks 0, 2, 6, 10, and 14, then every 4 or 8 weeks thereafter.
Vedolizumab has been approved in many countries for use in CD. However, this study includes 1 extra injection of vedolizumab at Week 10 which is considered investigational.
This study is paid for by Takeda Development Center Americas, Inc., the pharmaceutical company who developed vedolizumab.
Alimentiv, Inc., is the sponsor of the study and is responsible for running the study.REC name
London - South East Research Ethics Committee
REC reference
24/LO/0360
Date of REC Opinion
20 Jun 2024
REC opinion
Further Information Favourable Opinion