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

NCT06257706 | Recruiting Phase 4 DMC FDA Drug

• 1 other identifier: TAK01769
• Study Type: interventional
• Target: 304
• Locations: 13 countries
• Sites: 69

Brief Summary

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.

Conditions

Moderately to Severely Active Crohn's Disease; Crohn Disease; Disease Crohn

Outcome Measures

Primary Outcomes (1)

• Percentage of participants with Corticosteroid-free Endoscopic remission in group 1 and group 2 at week 48

  Corticosteroid-free is defined as not using corticosteroids at the time of the assessment. Endoscopic remission is defined by a total Simple Endoscopic Score for CD (SES-CD) ≤4 and at least a 2-point reduction versus baseline with no subscore greater than 1 in any individual variable. The SES-CD scores 4 endoscopic items (ulcer size, proportion of ulcerated surface, proportion of the surface area affected by any disease lesion, and stenosis) from 0 to 3, with higher scores representing more severe endoscopic disease activity. Each variable is scored for the 5 intestinal segments (ileum, right colon, transverse colon, left colon, and rectum) and summed to provide the total variable score. The sum of each variable score ranges from 0 to 15, except for stenosis (ranges from 0 to 11), because 3 represents a stenosis through which a colonoscope cannot be passed and therefore, can only be observed once. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).

  week 48

Secondary Outcomes (35)

• Percentage of participants with Corticosteroid-free Transmural healing (TMH)+Endoscopic remission+Clinical remission in group 1 and group 2 at week 48

  week 48

• Percentage of participants with Corticosteroid-free IUS response+Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48

  week 48

• Percentage of participants with Corticosteroid-free Endoscopic remission+Clinical Remission in group 1 and group 2 at week 48

  week 48

• Percentage of participants with Corticosteroid-free endoscopic response+Clinical response in group 1 and group 2 at week 48

  week 48

• Percentage of participants with Corticosteroid-free clinical remission in group 1 and group 2 at Week 14, Week 22 and Week 48.

  week 14, week 22 and week 48

Study Arms (2)

Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission

OTHER

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.

Biological: Vedolizumab

Group 2: Corticosteroid-free clinical remission + biomarker remission.

OTHER

Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.

Biological: Vedolizumab

Interventions

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. 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 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission; Group 2: Corticosteroid-free clinical remission + biomarker remission.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18 to 80 years, inclusive, at the time of consent;
• 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);
• 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;
• 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;
• Participants may continue stable dose (initiated at least 4 weeks prior to Screening) of 5-ASA for CD;
• 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;
• Able to participate fully in all aspects of this clinical trial;
• Written informed consent must be obtained and documented.

You may not qualify if:

• 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 molecule drug) for the treatment of their CD;
• 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;
• Only have inflammation proximal to the terminal ileum that cannot be reached by ileocolonoscopy;
• Have a CD complication, such as symptomatic strictures in the small bowel with \>3 cm prestenotic dilatation on any imaging modality, requiring procedural intervention;
• 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;
• Ostomy or ileoanal pouch;
• Short bowel syndrome;
• Fibrotic-only stricture in the ileum or colon without evidence of active inflammation (in the investigator's judgment), including any impassable stenosis;
• Abscess \>2 cm, detected by IUS or endoscopy; participants with draining fistulas are not excluded;
• 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;
• Positive stool test for Clostridioides difficile infection (as demonstrated by positive toxin);
• 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;
• 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;
• Other systemic or opportunistic infection (including cytomegalovirus), any other clinically significant extraintestinal infection, or recurring infection within 6 months of randomization;

Sponsors & Collaborators

• Takeda: collaborator
• Alimentiv Inc.: lead

Study Sites (69)

TLC Clinical Research Inc - Los Angeles

Los Angeles, California, 90048, United States

WITHDRAWN

Medical University of South Carolina (MUSC)

Charleston, South Carolina, 29425, United States

NOT YET RECRUITING

Houston Methodist Hospital

Houston, Texas, 77030, United States

RECRUITING

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

RECRUITING

Mater Misericordiae Ltd

South Brisbane, Queensland, 4101, Australia

RECRUITING

Calvary Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

RECRUITING

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

RECRUITING

Northern Hospital Epping

Epping, Victoria, 3076, Australia

RECRUITING

Austin Health

Heidelberg, Victoria, 3084, Australia

RECRUITING

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

RECRUITING

Royal Melbourne Hospital

Melbourne, Victoria, Australia

RECRUITING

Harry Perkins institute of Medical Research - Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

VITAZ - AZ Nikolaas

Sint-Niklaas, Antwerpen, 9100, Belgium

RECRUITING

Imelda Ziekenhuis Bonheiden

Bonheiden, Antwerp, 2820, Belgium

RECRUITING

University Hospital Ghent

Ghent, East Flanders, 9000, Belgium

RECRUITING

UZ Leuven-University Hospital Gasthuisberg

Leuven, Flemish Brabant, 3000, Belgium

RECRUITING

AZ Delta - Rumbeke Campus

Roeselare, West Flanders, 8800, Belgium

RECRUITING

ULB Hopital Erasme

Brussels, 1070, Belgium

RECRUITING

University of Calgary

Calgary, Alberta, T2N 4Z6, Canada

RECRUITING

University of Alberta, Dept of Medicine, Division of Gastroenterology

Edmonton, Alberta, T6G 2X8, Canada

RECRUITING

Viable Clinical Research - Bridgewater

Bridgewater, Nova Scotia, B4V 3N2, Canada

RECRUITING

LHSC - University Campus

London, Ontario, N6A 5A5, Canada

RECRUITING

LHSC - Victoria Hospital

London, Ontario, N6A 5W9, Canada

NOT YET RECRUITING

Toronto Immune and Digestive Health Institute Inc. (TIDHI)

Toronto, Ontario, Canada

RECRUITING

Vojenska nemocnice Brno

Brno, South Moravian, 615 00, Czechia

NOT YET RECRUITING

Fakultni Nemocnice Brno

Brno, South Moravian, 625 00, Czechia

NOT YET RECRUITING

Herlev Hospital

Herlev, Capital Region, 2730, Denmark

RECRUITING

Nordsjaellands Hospital - Hillerod

Hillerød, Capital Region, 3400, Denmark

RECRUITING

Bispebjerg Hospital

Copenhagen NV, Capital, 2400, Denmark

RECRUITING

Hvidovre Hospital

Hvidovre, Capital, 2650, Denmark

RECRUITING

Aarhus Universitetshospital

Aarhus, Central Denmark, 8200, Denmark

RECRUITING

Randers Regional Hospital

Randers, Central Denmark, 83930, Denmark

RECRUITING

Sjaellands Universitets hospitall Koge

Køge, Region Sjælland, 4600, Denmark

WITHDRAWN

Svendborg Hospital

Svendborg, Denmark

WITHDRAWN

Hopital Lyon Sud

Pierre-Bénite, Auvergne-Rhône-Alpes, 69495, France

RECRUITING

APHM

Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France

RECRUITING

Groupe Hospitalier Prive Ambroise Pare - Hartmann

Neuilly-sur-Seine, France

WITHDRAWN

Universitatsklinikum Augsburg

Augsburg, Bavaria, 86156, Germany

NOT YET RECRUITING

Universitatsklinkum Frankfurt - Goethe Universitat

Frankfurt am Main, Hesse, 60590, Germany

WITHDRAWN

Klinikum Luneburg

Lüneburg, Lower Saxony, 21339, Germany

RECRUITING

Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel

Kiel, Schleswig-Holstein, 24105, Germany

RECRUITING

Universitats Klinikum Freiburg

Freiburg im Breisgau, Germany

WITHDRAWN

Ospedale Casa Sollievo della Sofferenza IRCCS

San Giovanni Rotondo, Foggia, 71013, Italy

RECRUITING

Ospedale Luigi Sacco

Milan, Lombardy, 20157, Italy

RECRUITING

Ospedale San Raffaele S.r.I.

Milan, Milan, 20132, Italy

NOT YET RECRUITING

Policlinico Universitario Agostino Gemelli

Roma, Rome, 00168, Italy

RECRUITING

Radboud University Nijmegen Medical Centre

Nijmegen, Gelderland, 6525, Netherlands

RECRUITING

Amsterdam UMC - VU Medisch Centrum

Amsterdam, North Holland, 1081HV, Netherlands

RECRUITING

Erasmus Medisch Centrum (MC)

Rotterdam, South Holland, 3015 GD, Netherlands

NOT YET RECRUITING

ETZ - St. Elisabeth Hospital

Tilburg, Netherlands

WITHDRAWN

Oddzial Gastroenterologiczny SP ZOZ w Lecznej

Łęczna, Gmina Leczna, 21-010, Poland

RECRUITING

SOLUMED Centrum Medyczne

Poznan, Greater Poland Voivodeship, 60-529, Poland

RECRUITING

GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.

Torun, Kuyavian-Pomeranian Voivodeship, 87-100, Poland

RECRUITING

Melita Medical Sp Zoo

Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

RECRUITING

Bodyclinic Sp.z.o.o. Sp.K

Warsaw, Masovia, 03-712, Poland

RECRUITING

WIP Warsaw IBD Point Profesor Kierkus

Warsaw, Masovia, 04-501, Poland

RECRUITING

Centrum Medyczne Medyk

Rzeszów, Podkarpackie Voivodeship, 35-326, Poland

RECRUITING

Vita Longa Sp. z o.o.

Katowice, Silesian, 40-748, Poland

RECRUITING

Sonomed Sp. z o.o. - Centrum Medyczne

Szczecin, West Pomerianian, 71-685, Poland

RECRUITING

Twoja Przychodnia-Centrum Medyczne Opole

Opole, Poland

WITHDRAWN

EuroMediCare (EMC) Instytut Medyczny SA

Wroclaw, 54-144, 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, NG7 2UH, United Kingdom

RECRUITING

London North West University Healthcare NHS Trust - Northwick Park Hospital

Harrow, Middlesex, HA1 3UJ, United Kingdom

WITHDRAWN

Western General Hospital

Edinburgh, EH4 2XU, United Kingdom

NOT YET RECRUITING

Barts Health NHS Trust - The Royal London Hospital

London, E1 2AJ, United Kingdom

RECRUITING

University College London Hospitals NHS Foundation Trust

London, NW1 2BU, United Kingdom

RECRUITING

Kings College Hospital NHS Foundation Trust

London, SE5 9RS, United Kingdom

RECRUITING

Related Publications (1)

• Jairath V, Vuyyuru SK, Zou G, Ma C, Neustifter B, Agboton C, Romo Bautista I, Allocca M, An YK, Begun J, Bryant RV, Danese S, Dubinsky M, Feagan BG, Freire M, Novak KL, Panaccione R, Pudipeddi A, Rubin DT, Sands BE, Sparrow MP, Taylor SA, Gecse KB, Wilkens R, Maaser C. Evaluating treatment to a target of transmural healing in patients with moderately to severely active Crohn's disease: rationale, design and protocol for the randomised controlled VECTORS trial. BMJ Open Gastroenterol. 2026 Feb 20;13(1):e002088. doi: 10.1136/bmjgast-2025-002088.

  PMID: 41720589 DERIVED

MeSH Terms

Conditions

Crohn Disease

Interventions

vedolizumab

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Officials

• Vipul Jairath, MD

  Alimentiv Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Elena van Hest

CONTACT

31205630316; elena.vanhest@alimentiv.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Study participants and investigators will be unblinded to the treatment target group assignment. 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: This is an interventional, randomized, parallel-group, multicenter, controlled study. A total of approximately 304 participants with moderately-to-severely active CD from multiple international sites will be enrolled into this study. All qualified participants will be randomly assigned in a 1:1 ratio to one of 2 different treatment target groups: Group 1 will be treated over 48 weeks to achieve a target of corticosteroid-free IUS-based outcomes + clinical remission + biomarker remission. Group 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission. Randomization will be stratified by the following 3 baseline factors each with 2 levels: prior exposure (within the last 5 years of the screening date) to an approved biologic/small molecule for CD (yes or no), disease location (ileal or colonic), and disease duration (≤ 2 years or \>2 years, based on date of diagnosis).

Study Record Dates

• First Submitted: January 24, 2024
• First Posted: February 14, 2024
• Study Start: August 7, 2024
• Primary Completion (Estimated): January 3, 2029
• Study Completion (Estimated): February 6, 2029
• Last Updated: January 15, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF, ANALYTIC CODE
• Time Frame: 06JAN2026 - 31JAN2029
• Access Criteria: De-identified individual participant data underlying the results reported in this article may be made available upon reasonable request, subject to review and approval by the study sponsor, execution of a data use agreement, and in accordance with participant consent and applicable privacy and data protection requirements.

Locations

FR (3); DK (8); CA (6); CZ (2); IT (4); NL (4); US (3); AU (10); PT (1); GB (6); DE (5); PL (11); BE (6)