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
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
| Site | City | State | Status |
|---|---|---|---|
| Medical University of South Carolina (MUSC) | Charleston | South Carolina | Not yet recruiting |
| Houston Methodist Hospital | Houston | Texas | Recruiting |
| Concord Repatriation General Hospital | Concord | New South Wales | Recruiting |
| Mater Misericordiae Ltd | South Brisbane | Queensland | Recruiting |
| Calvary Adelaide Hospital | Adelaide | South Australia | Recruiting |
| Royal Adelaide Hospital | Adelaide | South Australia | Recruiting |
| The Queen Elizabeth Hospital | Woodville | South Australia | Recruiting |
| Northern Hospital Epping | Epping | Victoria | Recruiting |
| Austin Health | Heidelberg | Victoria | Recruiting |
| The Alfred Hospital | Melbourne | Victoria | Recruiting |
| Royal Melbourne Hospital | Melbourne | Victoria | Recruiting |
| Harry Perkins institute of Medical Research - Fiona Stanley Hospital | Murdoch | Western Australia | Recruiting |
| VITAZ - AZ Nikolaas | Sint-Niklaas | Antwerpen | Recruiting |
| Imelda Ziekenhuis Bonheiden | Bonheiden | Antwerp | Recruiting |
| University Hospital Ghent | Ghent | East Flanders | Recruiting |
| UZ Leuven-University Hospital Gasthuisberg | Leuven | Flemish Brabant | Recruiting |
| AZ Delta - Rumbeke Campus | Roeselare | West Flanders | Recruiting |
| ULB Hopital Erasme | Brussels | Belgium | Recruiting |
| University of Calgary | Calgary | Alberta | Recruiting |
| University of Alberta, Dept of Medicine, Division of Gastroenterology | Edmonton | Alberta | Recruiting |
| Viable Clinical Research - Bridgewater | Bridgewater | Nova Scotia | Recruiting |
| LHSC - University Campus | London | Ontario | Recruiting |
| LHSC - Victoria Hospital | London | Ontario | Not yet recruiting |
| Toronto Immune and Digestive Health Institute Inc. (TIDHI) | Toronto | Ontario | Recruiting |
| Vojenska nemocnice Brno | Brno | South Moravian | Not yet recruiting |
| Fakultni Nemocnice Brno | Brno | South Moravian | Not yet recruiting |
| Herlev Hospital | Herlev | Capital Region | Recruiting |
| Nordsjaellands Hospital - Hillerod | Hillerød | Capital Region | Recruiting |
| Bispebjerg Hospital | Copenhagen NV | Capital | Recruiting |
| Hvidovre Hospital | Hvidovre | Capital | Recruiting |
| Aarhus Universitetshospital | Aarhus | Central Denmark | Recruiting |
| Randers Regional Hospital | Randers | Central Denmark | Recruiting |
| Hopital Lyon Sud | Pierre-Bénite | Auvergne-Rhône-Alpes | Recruiting |
| APHM | Marseille | Provence-Alpes-Côte d'Azur Region | Recruiting |
| Universitatsklinikum Augsburg | Augsburg | Bavaria | Not yet recruiting |
| Klinikum Luneburg | Lüneburg | Lower Saxony | Recruiting |
| Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel | Kiel | Schleswig-Holstein | Recruiting |
| Ospedale Casa Sollievo della Sofferenza IRCCS | San Giovanni Rotondo | Foggia | Recruiting |
| Ospedale Luigi Sacco | Milan | Lombardy | Recruiting |
| Ospedale San Raffaele S.r.I. | Milan | Milan | Not yet recruiting |
| Policlinico Universitario Agostino Gemelli | Roma | Rome | Recruiting |
| Radboud University Nijmegen Medical Centre | Nijmegen | Gelderland | Recruiting |
| Amsterdam UMC - VU Medisch Centrum | Amsterdam | North Holland | Recruiting |
| Erasmus Medisch Centrum (MC) | Rotterdam | South Holland | Not yet recruiting |
| Oddzial Gastroenterologiczny SP ZOZ w Lecznej | Łęczna | Gmina Leczna | Recruiting |
| SOLUMED Centrum Medyczne | Poznan | Greater Poland Voivodeship | Recruiting |
| GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j. | Torun | Kuyavian-Pomeranian Voivodeship | Recruiting |
| Melita Medical Sp Zoo | Wroclaw | Lower Silesian Voivodeship | Recruiting |
| Bodyclinic Sp.z.o.o. Sp.K | Warsaw | Masovia | Recruiting |
| WIP Warsaw IBD Point Profesor Kierkus | Warsaw | Masovia | Recruiting |
| Centrum Medyczne Medyk | Rzeszów | Podkarpackie Voivodeship | Recruiting |
| Vita Longa Sp. z o.o. | Katowice | Silesian | Recruiting |
| Sonomed Sp. z o.o. - Centrum Medyczne | Szczecin | West Pomerianian | Recruiting |
| EuroMediCare (EMC) Instytut Medyczny SA | Wroclaw | Poland | Recruiting |
| LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria | Lisbon | Portugal | Not yet recruiting |
| Nottingham University Hospitals NHS Trust - QMC | Nottingham | East Midlands | Recruiting |
| Western General Hospital | Edinburgh | United Kingdom | Not yet recruiting |
| Barts Health NHS Trust - The Royal London Hospital | London | United Kingdom | Recruiting |
| University College London Hospitals NHS Foundation Trust | London | United Kingdom | Recruiting |
| Kings College Hospital NHS Foundation Trust | London | United Kingdom | Recruiting |
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.