At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Vedolizumab (biological)
- How long the study runs
- Study runs about 54 months (dates as stated)
- About the drug or intervention
- Vedolizumab — biological: All participants will begin a vedolizumab induction regimen of 300 mg IV at Weeks 0, 2, 6, and 10 followed by vedolizumab 300 mg IV every 8 weeks starting at Week 14.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study, called VECTORS, is looking at whether 'transmural healing' (healing through the full thickness of the bowel wall) can be used as a treatment goal in people with moderately to severely active Crohn's disease. The sponsor is Alimentiv Inc. What the treatment involves is not stated — ask the trial team.
Who can take part
- Adults aged 18 to 80
- Moderately to severely active Crohn's disease, measured by standard scoring tools (CDAI and SES-CD)
- Bowel wall thickness over 4.0 mm on an ultrasound scan
- Have never taken a biologic or similar advanced medicine, or have taken no more than one in the last 5 years
- May keep taking a stable dose of 5-ASA medicine for Crohn's disease
- Must use highly effective contraception if able to become pregnant, and have a negative pregnancy test before joining
- Able to take part fully and give written informed consent
Who may not be able to
- Current or previous treatment with vedolizumab, etrolizumab, or natalizumab
- Have taken 2 or more advanced medicines (biologics or similar) for Crohn's disease
- Recent steroid dose changes or a steroid dose above 40 mg prednisone (or equivalent) when joining
- Inflammation only in areas that cannot be reached by a colonoscopy
- Crohn's disease problems needing a procedure, such as serious bowel narrowing
- Extensive bowel surgery, including removal of parts of the colon, ileorectal anastomosis, or proctocolectomy
- Having an ostomy or ileoanal pouch, or short bowel syndrome
- Bowel narrowing caused by scarring only, with no active inflammation
- An abscess larger than 2 cm
- Other serious illnesses that could affect taking part or safety
- C. difficile infection in the stool
- HIV, hepatitis B or C, or tuberculosis
- Certain other infections, including cytomegalovirus, or repeat infections in the last 6 months
- History of brain or nervous system conditions such as progressive multifocal leukoencephalopathy (PML)
- Allergy or bad reaction to vedolizumab or its ingredients
- Serious active infections such as sepsis
- Unwilling to stop medicines not allowed in the trial
- Took part in another trial with an experimental treatment in the last 30 days
- History of alcohol or drug abuse that could affect following the study plan
- Took part in this study before and received study treatment
- Pregnant, breastfeeding, or planning a pregnancy or to donate eggs or sperm during the study or within 18 weeks after the last dose
- Had a live vaccine in the last 4 weeks, or planning one during the study
- People in mandatory military service, deprived of liberty, in residential care, or unable to take part due to a court decision
- Close family or staff of the study team
What taking part involves
- • Not stated — ask the trial team
Time commitment: Visit schedule and study duration are not stated — ask the trial team. Taking part involves ultrasound scans, colonoscopies with scoring, pregnancy testing if relevant, and following rules about which medicines you can take.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Testing a treatment
- Ages
- 18 Years to 80 Years
- Who
- All
- Number of participants
- 304
- Started
- 2024-08-07
- Last checked
- 2026-01
Plain English Summary
What is this study?
- • Testing a new treatment for moderately to severely active crohn's disease
- • Phase4 - 304 participants
- • Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target
Who can take part?
- • Ages 18 Years to 80 Years
- • Diagnosed with moderately to severely active crohn's disease
Where?
- • Nottingham - Nottingham University Hospitals NHS Trust - QMC
- • Harrow - London North West University Healthcare NHS Trust - Northwick Park Hospital
- • Edinburgh - Western General Hospital
- • London - Barts Health NHS Trust - The Royal London Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD). Qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different target treatment groups. Group 1: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. At Week 22 and 30, the IUS-based component of the target will be IUS response and at Week 38, the final treatment target will be TMH. Group 2: Participants will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 80 Years
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must have had:
- ✓ a negative serum pregnancy test
What the study is looking for
- ✓Adults aged 18 to 80 years, inclusive, at the time of consent;
- ✓BWT on IUS of \>4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean...
- ✓Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;
- ✓Able to participate fully in all aspects of this clinical trial;
- ✓Written agreement to take part must be obtained and documented.
Who cannot take part
- ✗Current or previous treatment with vedolizumab, etrolizumab, or natalizumab;
- ✗Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small...
- ✗Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \>40...
- ✗Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;
- ✗Have a CD complication, such as causing symptoms strictures in the small bowel with \>3 cm prestenotic dilatation on any...
See the full criteria
Where Is This Study? (6 UK sites)
Nottingham University Hospitals NHS Trust - QMC
Nottingham NG7 2UH, United Kingdom
London North West University Healthcare NHS Trust - Northwick Park Hospital
Harrow HA1 3UJ, United Kingdom
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London E1 2AJ, United Kingdom
University College London Hospitals NHS Foundation Trust
London NW1 2BU, United Kingdom
Kings College Hospital NHS Foundation Trust
London SE5 9RS, United Kingdom
How to Get in Touch
Elena van Hest
Sponsor contactCONTACT
