AzTrials
AzTrials

Moderately to Severely Active Crohn's DiseasePhase 4VECTORSNCT06257706

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

A Phase 4 study testing Vedolizumab in people with Moderately to Severely Active Crohn's Disease and Crohn Disease, run by Alimentiv Inc. at 69 sites in 13 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
Vedolizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
304 participants
Where
69 sitesin 13 countries
Study dates
7 Aug 2024to 6 Feb 2029
Phase
Phase 4

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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;
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  • 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;
  • Has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization;
  • Hypersensitivity, allergy, or intolerance to any excipient of vedolizumab or any other contraindication to vedolizumab;
  • Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
  • Unwillingness to withhold protocol-prohibited medications during the trial;
  • Concurrent or previous participation in another clinical trial and received any investigational therapy within 30 days prior to randomization;
  • 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;
  • Prior enrolment in the current study and had received study treatment;
  • 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;
  • 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;
  • 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;
  • 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).

Trial locations and contacts

69 sites in 13 countries. Contact the study team or a site near you to ask about taking part.

Elena van Hest contact

31205630316

elena.vanhest@alimentiv.com

69 sites in 13 countries

Poland11 sites, 10 recruiting

  • Vita Longa Sp. z o.o.

    Katowice, Silesian, 40-748

    Przemyslaw Ramos, MD

    Recruiting

  • Oddzial Gastroenterologiczny SP ZOZ w Lecznej

    Łęczna, Gmina Leczna, 21-010

    Lukasz Wolanski, MD

    Recruiting

  • Twoja Przychodnia-Centrum Medyczne Opole

    Opole

    Withdrawn

  • SOLUMED Centrum Medyczne

    Poznan, Greater Poland Voivodeship, 60-529

    Magdalena Andrzejewska, MD

    Recruiting

  • Centrum Medyczne Medyk

    Rzeszów, Podkarpackie Voivodeship, 35-326

    Rafal Filip, MD

    Recruiting

  • Sonomed Sp. z o.o. - Centrum Medyczne

    Szczecin, West Pomerianian, 71-685

    Anna Wiechowska-Kozlowska, MD

    Recruiting

  • GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.

    Torun, Kuyavian-Pomeranian Voivodeship, 87-100

    Adam Kopon, MD

    Recruiting

  • Bodyclinic Sp.z.o.o. Sp.K

    Warsaw, Masovia, 03-712

    Piotr Gietka, MD

    Recruiting

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Masovia, 04-501

    Jaroslaw Kierkus, MD

    Recruiting

  • Melita Medical Sp Zoo

    Wroclaw, Lower Silesian Voivodeship, 53-611

    Jaroslaw Leszczyszyn, MD

    Recruiting

  • EuroMediCare (EMC) Instytut Medyczny SA

    Wroclaw, 54-144

    Patryk Smolinski, MD

    Recruiting

Other trials in Poland

Australia10 sites, 10 recruiting

  • Calvary Adelaide Hospital

    Adelaide, South Australia, 5000

    Patricia Kaazan, MD

    Recruiting

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

    Kate Lynch, MD

    Recruiting

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

    Aviv Puddpedi, MD

    Recruiting

  • Northern Hospital Epping

    Epping, Victoria, 3076

    Mayur Garg, MD

    Recruiting

  • Austin Health

    Heidelberg, Victoria, 3084

    Peter De Cruz, MD

    Recruiting

  • The Alfred Hospital

    Melbourne, Victoria, 3004

    Miles Sparrow, MD

    Recruiting

  • Royal Melbourne Hospital

    Melbourne, Victoria

    Zaid Ardalan, MD

    Recruiting

  • Harry Perkins institute of Medical Research - Fiona Stanley Hospital

    Murdoch, Western Australia, 6150

    Lena Thin, MD

    Recruiting

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

    Jakob Begun, MD

    Recruiting

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

    Robert Bryant, MD

    Recruiting

Other trials in Australia

Denmark8 sites, 6 recruiting

  • Aarhus Universitetshospital

    Aarhus, Central Denmark, 8200

    Anders Dige, MD

    Recruiting

  • Bispebjerg Hospital

    Copenhagen NV, Capital, 2400

    Kristian Mikkelsen, MD

    Recruiting

  • Herlev Hospital

    Herlev, Capital Region, 2730

    Jacob Wium Bjerrum, MD

    Recruiting

  • Nordsjaellands Hospital - Hillerod

    Hillerød, Capital Region, 3400

    Salvatore Leotta, MD

    Recruiting

  • Hvidovre Hospital

    Hvidovre, Capital, 2650

    Klaus Theede, MD

    Recruiting

  • Sjaellands Universitets hospitall Koge

    Køge, Region Sjælland, 4600

    Withdrawn

  • Randers Regional Hospital

    Randers, Central Denmark, 83930

    Mia Bendix, MD

    Recruiting

  • Svendborg Hospital

    Svendborg

    Withdrawn

Other trials in Denmark

Belgium6 sites, 6 recruiting

  • Imelda Ziekenhuis Bonheiden

    Bonheiden, Antwerp, 2820

    Peter Bossuyt, MD

    Recruiting

  • ULB Hopital Erasme

    Brussels, 1070

    Denis Franchimont, MD

    Recruiting

  • University Hospital Ghent

    Ghent, East Flanders, 9000

    Triana Lobaton Ortega, MD

    Recruiting

  • UZ Leuven-University Hospital Gasthuisberg

    Leuven, Flemish Brabant, 3000

    Bram Verstockt, MD

    Recruiting

  • AZ Delta - Rumbeke Campus

    Roeselare, West Flanders, 8800

    Filip Baert, MD

    Recruiting

  • VITAZ - AZ Nikolaas

    Sint-Niklaas, Antwerpen, 9100

    Tom Holvoet, MD

    Recruiting

Other trials in Belgium

Canada6 sites, 6 recruiting

  • Viable Clinical Research - Bridgewater

    Bridgewater, Nova Scotia, B4V 3N2

    Hughie Fraser, MD

    Recruiting

  • University of Calgary

    Calgary, Alberta, T2N 4Z6

    Kerri Novak, MD

    Recruiting

  • University of Alberta, Dept of Medicine, Division of Gastroenterology

    Edmonton, Alberta, T6G 2X8

    Michal Gozdzik, MD

    Recruiting

  • LHSC - University Campus

    London, Ontario, N6A 5A5

    Melanie Beaton, MD

    Recruiting

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9

    Terry Ponich, MD

    Not yet recruiting

  • Toronto Immune and Digestive Health Institute Inc. (TIDHI)

    Toronto, Ontario

    Mark Silverberg, MD

    Recruiting

Other trials in Canada

United Kingdom6 sites, 5 recruiting

  • Western General Hospital

    Edinburgh, EH4 2XU

    Debbie Alexander, + 44 131 537 3858, debbie.alexander@ed.ac.uk

    Nikolas Plevris, MD

    Not yet recruiting

  • London North West University Healthcare NHS Trust - Northwick Park Hospital

    Harrow, Middlesex, HA1 3UJ

    Withdrawn

  • Barts Health NHS Trust - The Royal London Hospital

    London, E1 2AJ

    Gareth Parkes, MD

    Recruiting

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2BU

    Paul Harrow, MD

    Recruiting

  • Kings College Hospital NHS Foundation Trust

    London, SE5 9RS

    Polychronis Pavlidis

    Recruiting

  • Nottingham University Hospitals NHS Trust - QMC

    Nottingham, East Midlands, NG7 2UH

    Sunil Samuel

    Recruiting

Other trials in United Kingdom

Germany5 sites, 3 recruiting

  • Universitatsklinikum Augsburg

    Augsburg, Bavaria, 86156

    Elisabeth Schnoy, MD

    Not yet recruiting

  • Universitatsklinkum Frankfurt - Goethe Universitat

    Frankfurt am Main, Hesse, 60590

    Withdrawn

  • Universitats Klinikum Freiburg

    Freiburg im Breisgau

    Withdrawn

  • Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel

    Kiel, Schleswig-Holstein, 24105

    Stefan Schreiber, MD

    Recruiting

  • Klinikum Luneburg

    Lüneburg, Lower Saxony, 21339

    Christian Maaser, MD

    Recruiting

Other trials in Germany

Italy4 sites, 4 recruiting

  • Ospedale Luigi Sacco

    Milan, Lombardy, 20157

    Giovanni Maconi, MD

    Recruiting

  • Ospedale San Raffaele S.r.I.

    Milan, Milan, 20132

    Mariangela Allocca, MD

    Not yet recruiting

  • Policlinico Universitario Agostino Gemelli

    Roma, Rome, 00168

    Antonio Gasbarrini, MD

    Recruiting

  • Ospedale Casa Sollievo della Sofferenza IRCCS

    San Giovanni Rotondo, Foggia, 71013

    Fabrizio Bossa, MD

    Recruiting

Other trials in Italy

Netherlands4 sites, 3 recruiting

  • Amsterdam UMC - VU Medisch Centrum

    Amsterdam, North Holland, 1081HV

    Krisztina Gecse, MD

    Recruiting

  • Radboud University Nijmegen Medical Centre

    Nijmegen, Gelderland, 6525

    Marjolijn Duijvestein, MD

    Recruiting

  • Erasmus Medisch Centrum (MC)

    Rotterdam, South Holland, 3015 GD

    Annemarie De Vries, MD

    Not yet recruiting

  • ETZ - St. Elisabeth Hospital

    Tilburg

    Withdrawn

Other trials in Netherlands

United States3 sites, 2 recruiting

  • Medical University of South Carolina (MUSC)

    Charleston, South Carolina, 29425

    Erin Forster, MD

    Not yet recruiting

  • Houston Methodist Hospital

    Houston, Texas, 77030

    Bincy Abraham, MD

    Recruiting

  • TLC Clinical Research Inc - Los Angeles

    Los Angeles, California, 90048

    Withdrawn

Other trials in United States

France3 sites, 2 recruiting

  • APHM

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

    Melanie Serrero, MD

    Recruiting

  • Groupe Hospitalier Prive Ambroise Pare - Hartmann

    Neuilly-sur-Seine

    Withdrawn

  • Hopital Lyon Sud

    Pierre-Bénite, Auvergne-Rhône-Alpes, 69495

    Stephane Nancey, MD

    Recruiting

Other trials in France

Czechia2 sites, 2 recruiting

  • Vojenska nemocnice Brno

    Brno, South Moravian, 615 00

    David Stepek, MD

    Not yet recruiting

  • Fakultni Nemocnice Brno

    Brno, South Moravian, 625 00

    Stefan Konecny, MD

    Not yet recruiting

Other trials in Czechia

Portugal1 site, 1 recruiting

  • LisbonCentro Hospitalar Lisboa Norte, EPE- Hospital de Santa Maria

    Lisbon

    Samuel Fernandes, MD

    Not yet recruiting

Other trials in Portugal

About this study

Official title: An Interventional Study to Evaluate Treating to a Target of Transmural Healing in Patients With Moderately to Severely Active Crohn's Disease

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.

Being tested
Vedolizumab
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VedolizumabBiological

    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.

Study groups in NCT06257706
Study groupRoleWhat they receive
Group 1: Corticosteroid-free IUS-based outcomes + clinical remission + biomarker remissionOtherGroup 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.
Receives: Biological: Vedolizumab
Group 2: Corticosteroid-free clinical remission + biomarker remission.OtherGroup 2 will be treated over 48 weeks to achieve a target of corticosteroid-free clinical remission + biomarker remission.
Receives: Biological: Vedolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: week 48

Secondary outcomes (35)

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

    Transmural healing is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound.

    Endoscopic remission is defined by achievement of 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 assesses 4 endoscopic variables: the size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each variable score ranging from 0 to 3. The total SES-CD score is calculated using the sum of all parameter scores in 5 segments: terminal ileum, right colon, transverse colon, left colon, and rectum.

    Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) <150.

    CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: week 48

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

    IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS).

    Endoscopic remission is defined by achievement of 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.

    Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) <150.

    The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.

    Measured: week 48

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

    Endoscopic remission is defined by achievement of 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. 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. Total SES-CD score is then summed up the item scores (range, 0-56 points).

    Clinical Remission is defined by Crohn's Disease Activity Index (CDAI) <150. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: week 48

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

    Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. 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, higher scores indicate more severity. 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, where it ranges from 0 to 11. Total SES-CD score is then calculated by summing the item scores (range, 0-56 points).

    Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.

    Measured: week 48

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

    Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment.

    Clinical Remission is defined by achievement of Crohn's Disease Activity Index (CDAI) <150.

    The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.

    Measured: week 14, week 22 and week 48

  6. Percentage of participants with Corticosteroid-free Clinical Response in group 1 and group 2 at week 14, week 22 and week 48

    Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment.

    Clinical Response is defined by Crohn's Disease Activity Index (CDAI) decrease of ≥100 points from baseline. The CDAI consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.

    Measured: week 14, week 22 and week 48

  7. Crohn's Disease Activity Index(CDAI) total score and corresponding change from baseline during follow-up (Week 6, Week 14, Week 22, Week 30, Week 38, Week 48, Week 64, Week 80, Week 96) in group 1 and group 2

    Crohn's Disease Activity Index (CDAI) consists of 8 items including physical examination items, extraintestinal manifestations, the hematocrit, and PRO measures as recorded in the participant diary card for the 7 days prior to the clinic visit. Each item is multiplied by a weighting factor and summed to give a total CDAI score, ranging from 0 to over 600 points, with higher scores representing more severe disease activity.

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  8. Percentage of participants with Corticosteroid-free endoscopic response in group 1 and group 2 at week 48

    Corticosteroid-free is defined as not using corticosteroids for treatment of CD at the time of the assessment Endoscopic response is defined by Reduction in total Simple Endoscopic Score for CD (SES-CD) ≥50% from baseline. 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, where it 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).

    Measured: week 48

  9. SES-CD total score and corresponding change from baseline to Week 48 in group 1 and group 2

    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, where it 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).

    Measured: week 48

  10. Percentage of participants with Transmural healing (TMH) in group 1 and group 2 at week 48

    Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound

    Measured: week 48

  11. Percentage of participants with Intestinal Ultrasound (IUS) response in group 1 and group 2 at Week 48

    IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS)

    Measured: week 48

  12. Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at Week 48 in group 1 and group 2.

    Measured: week 48

  13. Color Doppler signal (CDS) and corresponding change from baseline at Week 48 in group 1 and group 2.

    Measured: week 48

  14. International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at Week 48 in group 1 and group 2

    International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters

    Measured: week 48

  15. Percentage of participants with Transmural healing (TMH) at week 14, week 22, week 30, week 38, and week 48 in group 1

    Transmural Healing (TMH) is defined by Bowel wall thickness (BWT) ≤3.0 mm and color Doppler signal (CDS) 0 in all evaluable segments assessed by Intestinal Ultrasound

    Measured: week 14, week 22, week 30, week 38, week 48

  16. Percentage of participants with Intestinal Ultrasound (IUS) response at week 14, week 22, week 30, week 38, and week 48 in group 1

    IUS response is defined by reduction from baseline of 25% in Bowel Wall thickness (BWT) assessed by Intestinal Ultrasound (IUS)

    Measured: week 14, week 22, week 30, week 38, week 48

  17. Bowel Wall Thickness (BWT) measured by Intestinal Ultrasound (IUS) in mm and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1

    Measured: week 14, week 22, week 30, week 38, week 48

  18. Color Doppler signal (CDS) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1

    Measured: week 14, week 22, week 30, week 38, week 48

  19. International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) (per segment as well as total) and corresponding change from baseline at week 14, week 22, week 30, week 38, and week 48 in group 1

    International Bowel Ultrasound Segmental Activity Score (IBUS-SAS) is a 0-100 numerical activity index for Crohn's disease calculated from four Intestinal Ultrasound (IUS) parameters

    Measured: week 14, week 22, week 30, week 38, week 48

  20. Percentage of participants with Histologic remission at week 48 in group 1 and group 2

    Histologic remission is defined by Robarts Histopathology Index (RHI) score ≤3 (per segment) with subscores of 0 for lamina propria neutrophils and 0 for neutrophils in epithelium, as scored by central reader.

    The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.

    Measured: week 48

  21. Percentage of participants with Histologic response at week 48 in group 1 and group 2

    Histologic response is defined as ≥7-point reduction from baseline in RHI, as scored by a central reader.

    The RHI is a validated instrument that measures histologic disease activity and consists of 4 subscores (chronic inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration). Each subscore ranges from 0-3, with higher subscores indicating greater histologic disease activity. The RHI score is calculated as: (1 x chronic inflammatory infiltrate) + (2 x lamina propria neutrophils) + (3 x neutrophils in epithelium) + (5 x erosion or ulceration). The RHI therefore ranges from 0-33, with higher scores indicating greater histologic disease activity.

    Measured: week 48

  22. Percentage of patients with Biomarker remission at week 48, week 64, week 80 and week 96 in group 1 and group 2

    Biomarker remission is defined as Normalization of C-reactive protein (CRP) <5 mg/mL and fecal calprotectin (FCal) <250 μg/g

    Measured: week 48, week 64, week 80, week 96

  23. Percentage of patients with Biomarker response at week 48, week 64, week 80 and week 96 in group 1 and group 2

    Biomarker response is defined as ≥50% reduction from baseline in either C-reactive protein (CRP) or fecal calprotectin (FCal)

    Measured: week 48, week 64, week 80, week 96

  24. Percentage of participants with C-reactive protein (CRP) response during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    C-reactive protein (CRP) response is defined by ≥50% reduction from baseline

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  25. Percentage of participants with fecal calprotectin (FCal) response during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    Fecal calprotectin (FCal) response is defined by ≥50% reduction from baseline

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  26. Changes in C-reactive protein (CRP) from baseline during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  27. Changes in fecal calprotectin (FCal) from baseline during follow-up (Week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  28. 2-item Patient-Reported Outcome (PRO-2) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    The PRO-2 consists of the 2 CDAI component items: daily stool frequency and abdominal pain. Study participants record the number of liquid or very soft stools and rate abdominal pain (range, 0-3) daily in their participant diary for the 7 days prior to a clinic visit, excluding days of bowel preparation and ileocolonoscopy. The stool frequency and abdominal pain scores are calculated as the average scores over the 7-day period.

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  29. Symptoms and Impacts Questionnaire for CD (SIQ-CD) score and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    SIQ-CD tool consists of a symptom domain, which includes Gastrointestinal (GI), pain and discomfort, nutrition-related, and fatigue-related symptoms; and an impact domain, which includes concepts related to daily activities, nutrition, emotional well-being, and productivity.

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  30. Urgency Numerical Rating Score (NRS) and corresponding changes from baseline during follow-up (Weeks 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80 and week 96) in group 1 and group 2

    The Urgency NRS evaluates the participant's sense of urgency to have a bowel movement over the previous 24 hours and is rated on an 11-point Likert scale, from 0 for "no urgency" to 10 for "worst possible urgency"

    Measured: week 6, week 14, week 22, week 30, week 38, week 48, week 64, week 80, week 96

  31. Inflammatory Bowel Disease Questionnaire (IBDQ) score and corresponding changes from baseline during follow-up (Weeks 30, week 48 and week 96) in group 1 and group 2

    The IBDQ measures health related quality of life in subjects with inflammatory bowel disease. It consists of 32 questions each with a graded response of 1 (worst) to 7 (best). The score ranges from 32 to 224

    Measured: week 30, week 48, week 96

  32. Time to CD-related complication from randomization through Week 96 in group 1 and group 2

    CD-related complication will be defined as any of the following: (1) CD-related surgery; (2) CD-related hospitalization; (3) CD medication-related complication; (4) CD procedure-related complication; (5) Rescue therapy for a documented CD-related flare e.g., new initiation of an advanced therapy other than VDZ (approved biologic or small molecule), dose escalation of vedolizumab, or dose intensification beyond the dose used at randomization of a corticosteroid after Week 48 or; (6) Other CD-related complication

    Measured: from randomization through Week 96

  33. Time to each component of CD-related complication in group 1 and group 2

    Measured: from randomization through Week 96

  34. Percentage of participants who switched to an alternate biologic (yes/no) by Week 48 and Week 96

    Measured: week 48, week 96

  35. Exposure-adjusted incidence rates of serious adverse events (SAEs), all adverse events (AEs), and AEs of special interest (AESIs) in group 1 and group 2

    Defined as the number of participants experiencing the event per 100 person-years (PYs) of exposure.

    Measured: up to week 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2024
  2. Study start7 Aug 2024
  3. Primary completion3 Jan 2029 (estimated)
  4. Study completion6 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
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).
Masking
None (open label)
Enrolment
304 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06257706
Sponsor's protocol ID
TAK01769
Acronym
VECTORS
Status last verified
Jan 2026
First submitted
24 Jan 2024
Last updated
15 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • 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.

    PubMed 41720589

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