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Looking for participantsPhase4

VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease

Sponsor: Alimentiv Inc.

NCT ID: NCT06257706

View on ClinicalTrials.gov ↗

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.

Moderately to Severely Active Crohn's DiseaseCrohn DiseaseDisease Crohn

How this trial compares with your answers

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What we know so far

Condition· Matched your search
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Still need:

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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

have a negativedemonstrated by positiveIf a negative

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
Inclusion Criteria: 1. Adults aged 18 to 80 years, inclusive, at the time of consent; 2. Moderately to severely active CD at baseline defined by a CDAI score of 220 to 450 inclusive and SES-CD, excluding the presence of narrowing component, ≥6 (or ≥4 for participants with isolated ileal disease); 3. BWT on IUS of \>4.0 mm in the terminal ileum or any colonic segment (excluding the rectum) as assessed by the mean of 2 longitudinal and 2 cross-sectional measurements of the same segment; 4. Biologic-naïve or have previous exposure (within the last 5 years of the screening date) to no more than 1 advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD. Note: only approximately 15% to 30% of the enrolled population will have had prior exposure to an advanced therapeutic; 5. Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD; 6. Persons of childbearing potential must have a negative serum pregnancy test prior to randomization and must use a highly effective method of contraception throughout the study. Females unable to bear children must have documentation of such in the source records; 7. Able to participate fully in all aspects of this clinical trial; 8. Written informed consent must be obtained and documented. Exclusion Criteria: 1. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab; 2. Previously exposed to 2 or more compounds or classes of an advanced therapeutic compound (approved biologic or small molecule drug) for the treatment of their CD; 3. Change to oral corticosteroid therapy dosing within 2 weeks prior to randomization or a corticosteroid dose of \>40 mg of prednisone or equivalent at randomization; 4. Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy; 5. Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention; 6. Previous extensive colonic resection or missing \>2 segments out of 5 (terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum), ileorectal anastomosis, or a proctocolectomy; 7. Ostomy or ileoanal pouch; 8. Short bowel syndrome; 9. Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis; 10. Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded; 11. Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the participant's ability to participate fully in the study or would compromise participant safety; 12. Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin); 13. Known HIV or hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required; 14. Known active or latent tuberculosis (TB); if a negative test result is available in the 12 months prior to randomization, confirmatory testing (per standard of care) is not required before randomization; 15. Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization; 16. Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization; 17. Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab; 18. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection. 19. Unwillingness to withhold protocol-prohibited medications during the trial; 20. Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization; 21. History of alcohol or drug abuse that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures; 22. Prior enrolment in the current study and had received study treatment; 23. Pregnant, lactating, or intending to become pregnant/impregnate a partner before, during, or within 18 weeks after the last dose; or intending to donate ova or sperm during such time period; 24. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination with a live or live-attenuated vaccine during participation in the study; 25. Any person performing mandatory military service, deprived of liberty, in a residential care setting, or any person who, due to a judicial decision, cannot take part in clinical studies; 26. The person is an immediate family member, study site employee, or is in a dependent relationship with a study site employee who is involved in conduct of this study (e.g., spouse, parent, child, sibling).

Where Is This Study? (6 UK sites)

Nottingham University Hospitals NHS Trust - QMC

Nottingham NG7 2UH, United Kingdom

Recruiting
Site contact (verified)
Sunil SamuelPrincipal Investigator

London North West University Healthcare NHS Trust - Northwick Park Hospital

Harrow HA1 3UJ, United Kingdom

WITHDRAWN
Hospital R&D contact (matched)

Sunder Chita

Lnwh-tr.Research@nhs.net020 8869 5829

Western General Hospital

Edinburgh EH4 2XU, United Kingdom

NOT_YET_RECRUITING
Site contact (verified)
Nikolas Plevris, MDPrincipal Investigator

Barts Health NHS Trust - The Royal London Hospital

London E1 2AJ, United Kingdom

Recruiting
Site contact (verified)
Gareth Parkes, MDPrincipal Investigator

University College London Hospitals NHS Foundation Trust

London NW1 2BU, United Kingdom

Recruiting
Site contact (verified)
Paul Harrow, MDPrincipal Investigator

Kings College Hospital NHS Foundation Trust

London SE5 9RS, United Kingdom

Recruiting
Site contact (verified)
Polychronis PavlidisPrincipal Investigator

How to Get in Touch

Elena van Hest

Sponsor contact

CONTACT

31205630316 elena.vanhest@alimentiv.com
Data sourced from ClinicalTrials.gov · Last verified: 2026-01