VECTORS - A Study to Evaluate Transmural Healing as a Treatment Target in Crohn's Disease
NCT ID: NCT06257706
Last Updated: 2026-01-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE4
304 participants
INTERVENTIONAL
2024-08-07
2029-02-06
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Central readers performing the assessment of IUS, endoscopy, and histology assessments will be blinded to treatment target randomization, participant, treatment received, and timepoint which will be used to determine treatment escalation.
Study Groups
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Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission
Group 1 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.
Vedolizumab
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. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points.
Group 2: Corticosteroid-free clinical remission + biomarker remission.
Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.
Vedolizumab
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. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points.
Interventions
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Vedolizumab
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. Treatment may be modified at Weeks 22, 30, and/or 38 based on the results of the target assessment at each of these time points.
Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
80 Years
ALL
No
Sponsors
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Takeda
INDUSTRY
Alimentiv Inc.
OTHER
Responsible Party
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Principal Investigators
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Vipul Jairath, MD
Role: PRINCIPAL_INVESTIGATOR
Alimentiv Inc.
Locations
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TLC Clinical Research Inc - Los Angeles
Los Angeles, California, United States
Medical University of South Carolina (MUSC)
Charleston, South Carolina, United States
Houston Methodist Hospital
Houston, Texas, United States
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia
Calvary Adelaide Hospital
Adelaide, South Australia, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Queen Elizabeth Hospital
Woodville, South Australia, Australia
Northern Hospital Epping
Epping, Victoria, Australia
Austin Health
Heidelberg, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Royal Melbourne Hospital
Melbourne, Victoria, Australia
Harry Perkins institute of Medical Research - Fiona Stanley Hospital
Murdoch, Western Australia, Australia
VITAZ - AZ Nikolaas
Sint-Niklaas, Antwerpen, Belgium
Imelda Ziekenhuis Bonheiden
Bonheiden, Antwerp, Belgium
University Hospital Ghent
Ghent, East Flanders, Belgium
UZ Leuven-University Hospital Gasthuisberg
Leuven, Flemish Brabant, Belgium
AZ Delta - Rumbeke Campus
Roeselare, West Flanders, Belgium
ULB Hopital Erasme
Brussels, , Belgium
University of Calgary
Calgary, Alberta, Canada
University of Alberta, Dept of Medicine, Division of Gastroenterology
Edmonton, Alberta, Canada
Viable Clinical Research - Bridgewater
Bridgewater, Nova Scotia, Canada
LHSC - University Campus
London, Ontario, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
Toronto Immune and Digestive Health Institute Inc. (TIDHI)
Toronto, Ontario, Canada
Vojenska nemocnice Brno
Brno, South Moravian, Czechia
Fakultni Nemocnice Brno
Brno, South Moravian, Czechia
Herlev Hospital
Herlev, Capital Region, Denmark
Nordsjaellands Hospital - Hillerod
Hillerød, Capital Region, Denmark
Bispebjerg Hospital
Copenhagen NV, Capital, Denmark
Hvidovre Hospital
Hvidovre, Capital, Denmark
Aarhus Universitetshospital
Aarhus, Central Denmark, Denmark
Randers Regional Hospital
Randers, Central Denmark, Denmark
Sjaellands Universitets hospitall Koge
Køge, Region Sjælland, Denmark
Svendborg Hospital
Svendborg, , Denmark
Hopital Lyon Sud
Pierre-Bénite, Auvergne-Rhône-Alpes, France
APHM
Marseille, Provence-Alpes-Côte d'Azur Region, France
Groupe Hospitalier Prive Ambroise Pare - Hartmann
Neuilly-sur-Seine, , France
Universitatsklinikum Augsburg
Augsburg, Bavaria, Germany
Universitatsklinkum Frankfurt - Goethe Universitat
Frankfurt am Main, Hesse, Germany
Klinikum Luneburg
Lüneburg, Lower Saxony, Germany
Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel
Kiel, Schleswig-Holstein, Germany
Universitats Klinikum Freiburg
Freiburg im Breisgau, , Germany
Ospedale Casa Sollievo della Sofferenza IRCCS
San Giovanni Rotondo, Foggia, Italy
Ospedale Luigi Sacco
Milan, Lombardy, Italy
Ospedale San Raffaele S.r.I.
Milan, Milan, Italy
Policlinico Universitario Agostino Gemelli
Roma, Rome, Italy
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Amsterdam UMC - VU Medisch Centrum
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum (MC)
Rotterdam, South Holland, Netherlands
ETZ - St. Elisabeth Hospital
Tilburg, , Netherlands
Oddzial Gastroenterologiczny SP ZOZ w Lecznej
Łęczna, Gmina Leczna, Poland
SOLUMED Centrum Medyczne
Poznan, Greater Poland Voivodeship, Poland
GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Melita Medical Sp Zoo
Wroclaw, Lower Silesian Voivodeship, Poland
Bodyclinic Sp.z.o.o. Sp.K
Warsaw, Masovia, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovia, Poland
Centrum Medyczne Medyk
Rzeszów, Podkarpackie Voivodeship, Poland
Vita Longa Sp. z o.o.
Katowice, Silesian, Poland
Sonomed Sp. z o.o. - Centrum Medyczne
Szczecin, West Pomerianian, Poland
Twoja Przychodnia-Centrum Medyczne Opole
Opole, , Poland
EuroMediCare (EMC) Instytut Medyczny SA
Wroclaw, , Poland
LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria
Lisbon, , Portugal
Nottingham University Hospitals NHS Trust - QMC
Nottingham, East Midlands, United Kingdom
London North West University Healthcare NHS Trust - Northwick Park Hospital
Harrow, Middlesex, United Kingdom
Western General Hospital
Edinburgh, , United Kingdom
Barts Health NHS Trust - The Royal London Hospital
London, , United Kingdom
University College London Hospitals NHS Foundation Trust
London, , United Kingdom
Kings College Hospital NHS Foundation Trust
London, , United Kingdom
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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TAK01769
Identifier Type: -
Identifier Source: org_study_id
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