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

ClinicalTrials.gov ID NCT06257706 · An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease

View the official record

At a glance

Status
Recruiting
Condition
Moderately to Severely Active Crohn's Disease, Crohn Disease, Disease Crohn
Phase
Phase 4
Ages
18 Years to 80 Years
Sex
All
Healthy volunteers
Not accepted
What is being studied
Vedolizumab (biological)
Sponsor
Alimentiv Inc.
Target enrollment
304 participants
Study sites
60 open in Alberta, Antwerp, Antwerpen, Auvergne-Rhône-Alpes, Bavaria, Belgium, Capital, Capital Region, Central Denmark, East Flanders, East Midlands, Flemish Brabant, Foggia, Gelderland, Gmina Leczna, Greater Poland Voivodeship, Kuyavian-Pomeranian Voivodeship, Lombardy, Lower Saxony, Lower Silesian Voivodeship, Masovia, Milan, New South Wales, North Holland, Nova Scotia, Ontario, Podkarpackie Voivodeship, Poland, Portugal, Provence-Alpes-Côte d'Azur Region, Queensland, Rome, Schleswig-Holstein, Silesian, South Australia, South Carolina, South Holland, South Moravian, Texas, United Kingdom, Victoria, West Flanders, West Pomerianian, Western Australia
Start date
2024-08-07
Primary completion
2029-01-03

Common questions

Is NCT06257706 still recruiting?

ClinicalTrials.gov lists this trial as recruiting (checked 5 October 2026). It has 60 open or upcoming sites.

Who can take part in NCT06257706?

The record lists people aged 18 to 80 years with moderately to severely active crohn's disease, crohn disease, disease crohn. The study team decides who is eligible, and the full criteria are on this page and in the official record.

Where is NCT06257706 running?

60 sites in Alberta, Antwerp, Antwerpen, Auvergne-Rhône-Alpes, Bavaria, Belgium, Capital, Capital Region, Central Denmark, East Flanders, East Midlands, Flemish Brabant, Foggia, Gelderland, Gmina Leczna, Greater Poland Voivodeship, Kuyavian-Pomeranian Voivodeship, Lombardy, Lower Saxony, Lower Silesian Voivodeship, Masovia, Milan, New South Wales, North Holland, Nova Scotia, Ontario, Podkarpackie Voivodeship, Poland, Portugal, Provence-Alpes-Côte d'Azur Region, Queensland, Rome, Schleswig-Holstein, Silesian, South Australia, South Carolina, South Holland, South Moravian, Texas, United Kingdom, Victoria, West Flanders, West Pomerianian, Western Australia, according to ClinicalTrials.gov.

What is being studied in NCT06257706?

It is a Phase 4 trial. The record lists this intervention: Vedolizumab. The sponsor is Alimentiv Inc.

How many people will NCT06257706 enroll?

The record gives a target of 304 participants.

How do I sign up for NCT06257706?

Contact the study team listed in the official ClinicalTrials.gov record.

About this trial

From the ClinicalTrials.gov record.

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.

Where it's running

SiteCityStateStatus
Medical University of South Carolina (MUSC)CharlestonSouth CarolinaNot yet recruiting
Houston Methodist HospitalHoustonTexasRecruiting
Concord Repatriation General HospitalConcordNew South WalesRecruiting
Mater Misericordiae LtdSouth BrisbaneQueenslandRecruiting
Calvary Adelaide HospitalAdelaideSouth AustraliaRecruiting
Royal Adelaide HospitalAdelaideSouth AustraliaRecruiting
The Queen Elizabeth HospitalWoodvilleSouth AustraliaRecruiting
Northern Hospital EppingEppingVictoriaRecruiting
Austin HealthHeidelbergVictoriaRecruiting
The Alfred HospitalMelbourneVictoriaRecruiting
Royal Melbourne HospitalMelbourneVictoriaRecruiting
Harry Perkins institute of Medical Research - Fiona Stanley HospitalMurdochWestern AustraliaRecruiting
VITAZ - AZ NikolaasSint-NiklaasAntwerpenRecruiting
Imelda Ziekenhuis BonheidenBonheidenAntwerpRecruiting
University Hospital GhentGhentEast FlandersRecruiting
UZ Leuven-University Hospital GasthuisbergLeuvenFlemish BrabantRecruiting
AZ Delta - Rumbeke CampusRoeselareWest FlandersRecruiting
ULB Hopital ErasmeBrusselsBelgiumRecruiting
University of CalgaryCalgaryAlbertaRecruiting
University of Alberta, Dept of Medicine, Division of GastroenterologyEdmontonAlbertaRecruiting
Viable Clinical Research - BridgewaterBridgewaterNova ScotiaRecruiting
LHSC - University CampusLondonOntarioRecruiting
LHSC - Victoria HospitalLondonOntarioNot yet recruiting
Toronto Immune and Digestive Health Institute Inc. (TIDHI)TorontoOntarioRecruiting
Vojenska nemocnice BrnoBrnoSouth MoravianNot yet recruiting
Fakultni Nemocnice BrnoBrnoSouth MoravianNot yet recruiting
Herlev HospitalHerlevCapital RegionRecruiting
Nordsjaellands Hospital - HillerodHillerødCapital RegionRecruiting
Bispebjerg HospitalCopenhagen NVCapitalRecruiting
Hvidovre HospitalHvidovreCapitalRecruiting
Aarhus UniversitetshospitalAarhusCentral DenmarkRecruiting
Randers Regional HospitalRandersCentral DenmarkRecruiting
Hopital Lyon SudPierre-BéniteAuvergne-Rhône-AlpesRecruiting
APHMMarseilleProvence-Alpes-Côte d'Azur RegionRecruiting
Universitatsklinikum AugsburgAugsburgBavariaNot yet recruiting
Klinikum LuneburgLüneburgLower SaxonyRecruiting
Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus KielKielSchleswig-HolsteinRecruiting
Ospedale Casa Sollievo della Sofferenza IRCCSSan Giovanni RotondoFoggiaRecruiting
Ospedale Luigi SaccoMilanLombardyRecruiting
Ospedale San Raffaele S.r.I.MilanMilanNot yet recruiting
Policlinico Universitario Agostino GemelliRomaRomeRecruiting
Radboud University Nijmegen Medical CentreNijmegenGelderlandRecruiting
Amsterdam UMC - VU Medisch CentrumAmsterdamNorth HollandRecruiting
Erasmus Medisch Centrum (MC)RotterdamSouth HollandNot yet recruiting
Oddzial Gastroenterologiczny SP ZOZ w LecznejŁęcznaGmina LecznaRecruiting
SOLUMED Centrum MedycznePoznanGreater Poland VoivodeshipRecruiting
GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.TorunKuyavian-Pomeranian VoivodeshipRecruiting
Melita Medical Sp ZooWroclawLower Silesian VoivodeshipRecruiting
Bodyclinic Sp.z.o.o. Sp.KWarsawMasoviaRecruiting
WIP Warsaw IBD Point Profesor KierkusWarsawMasoviaRecruiting
Centrum Medyczne MedykRzeszówPodkarpackie VoivodeshipRecruiting
Vita Longa Sp. z o.o.KatowiceSilesianRecruiting
Sonomed Sp. z o.o. - Centrum MedyczneSzczecinWest PomerianianRecruiting
EuroMediCare (EMC) Instytut Medyczny SAWroclawPolandRecruiting
LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa MariaLisbonPortugalNot yet recruiting
Nottingham University Hospitals NHS Trust - QMCNottinghamEast MidlandsRecruiting
Western General HospitalEdinburghUnited KingdomNot yet recruiting
Barts Health NHS Trust - The Royal London HospitalLondonUnited KingdomRecruiting
University College London Hospitals NHS Foundation TrustLondonUnited KingdomRecruiting
Kings College Hospital NHS Foundation TrustLondonUnited KingdomRecruiting
Full eligibility criteria (from the record)

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).

Other recruiting trials: Moderately to severely active crohn's disease clinical trials

This listing shows only what the public ClinicalTrials.gov record NCT06257706 says, last updated there on 2026-01-15. It was checked against the registry on 5 October 2026. Taking part is voluntary, and the study team decides who is eligible. For the most current details, see the official record.