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Can Ultrasound-Guided healing beat standard care for Crohn's?

NCT ID NCT06257706

Disease control Sponsor: Alimentiv Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether treating Crohn's disease with a goal of healing the entire gut wall (seen on ultrasound) leads to better results than treating based on symptoms and blood tests alone. About 304 adults with moderate to severe Crohn's will be split into two groups and followed for 48 weeks. The aim is to see if the ultrasound-guided approach helps more people achieve remission without steroids.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 304 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2024

Expected to finish

Feb 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

Crohn disease

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Crohn disease Disease Crohn Moderately to severely active Crohn's disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    60 sites in 13 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • APHM

    RECRUITING

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

  • AZ Delta - Rumbeke Campus

    RECRUITING

    Roeselare, West Flanders, 8800, Belgium

  • Aarhus Universitetshospital

    RECRUITING

    Aarhus, Central Denmark, 8200, Denmark

  • Amsterdam UMC - VU Medisch Centrum

    RECRUITING

    Amsterdam, North Holland, 1081HV, Netherlands

  • Austin Health

    RECRUITING

    Heidelberg, Victoria, 3084, Australia

  • Barts Health NHS Trust - The Royal London Hospital

    RECRUITING

    London, E1 2AJ, United Kingdom

  • Bispebjerg Hospital

    RECRUITING

    Copenhagen NV, Capital, 2400, Denmark

  • Bodyclinic Sp.z.o.o. Sp.K

    RECRUITING

    Warsaw, Masovia, 03-712, Poland

  • Calvary Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Centrum Medyczne Medyk

    RECRUITING

    Rzeszów, Podkarpackie Voivodeship, 35-326, Poland

  • Concord Repatriation General Hospital

    RECRUITING

    Concord, New South Wales, 2139, Australia

  • ETZ - St. Elisabeth Hospital

    WITHDRAWN

    Tilburg, Netherlands

  • Erasmus Medisch Centrum (MC)

    NOT_YET_RECRUITING

    Rotterdam, South Holland, 3015 GD, Netherlands

  • EuroMediCare (EMC) Instytut Medyczny SA

    RECRUITING

    Wroclaw, 54-144, Poland

  • Fakultni Nemocnice Brno

    NOT_YET_RECRUITING

    Brno, South Moravian, 625 00, Czechia

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

    RECRUITING

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

  • Groupe Hospitalier Prive Ambroise Pare - Hartmann

    WITHDRAWN

    Neuilly-sur-Seine, France

  • Harry Perkins institute of Medical Research - Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Herlev Hospital

    RECRUITING

    Herlev, Capital Region, 2730, Denmark

  • Hopital Lyon Sud

    RECRUITING

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

  • Houston Methodist Hospital

    RECRUITING

    Houston, Texas, 77030, United States

  • Hvidovre Hospital

    RECRUITING

    Hvidovre, Capital, 2650, Denmark

  • Imelda Ziekenhuis Bonheiden

    RECRUITING

    Bonheiden, Antwerp, 2820, Belgium

  • Kings College Hospital NHS Foundation Trust

    RECRUITING

    London, SE5 9RS, United Kingdom

  • Klinikum Luneburg

    RECRUITING

    Lüneburg, Lower Saxony, 21339, Germany

  • LHSC - University Campus

    RECRUITING

    London, Ontario, N6A 5A5, Canada

  • LHSC - Victoria Hospital

    NOT_YET_RECRUITING

    London, Ontario, N6A 5W9, Canada

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

    NOT_YET_RECRUITING

    Lisbon, Portugal

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

    WITHDRAWN

    Harrow, Middlesex, HA1 3UJ, United Kingdom

  • Mater Misericordiae Ltd

    RECRUITING

    South Brisbane, Queensland, 4101, Australia

  • Medical University of South Carolina (MUSC)

    NOT_YET_RECRUITING

    Charleston, South Carolina, 29425, United States

  • Melita Medical Sp Zoo

    RECRUITING

    Wroclaw, Lower Silesian Voivodeship, 53-611, Poland

  • Nordsjaellands Hospital - Hillerod

    RECRUITING

    Hillerød, Capital Region, 3400, Denmark

  • Northern Hospital Epping

    RECRUITING

    Epping, Victoria, 3076, Australia

  • Nottingham University Hospitals NHS Trust - QMC

    RECRUITING

    Nottingham, East Midlands, NG7 2UH, United Kingdom

  • Oddzial Gastroenterologiczny SP ZOZ w Lecznej

    RECRUITING

    Łęczna, Gmina Leczna, 21-010, Poland

  • Ospedale Casa Sollievo della Sofferenza IRCCS

    RECRUITING

    San Giovanni Rotondo, Foggia, 71013, Italy

  • Ospedale Luigi Sacco

    RECRUITING

    Milan, Lombardy, 20157, Italy

  • Ospedale San Raffaele S.r.I.

    NOT_YET_RECRUITING

    Milan, Milan, 20132, Italy

  • Policlinico Universitario Agostino Gemelli

    RECRUITING

    Roma, Rome, 00168, Italy

  • Radboud University Nijmegen Medical Centre

    RECRUITING

    Nijmegen, Gelderland, 6525, Netherlands

  • Randers Regional Hospital

    RECRUITING

    Randers, Central Denmark, 83930, Denmark

  • Royal Adelaide Hospital

    RECRUITING

    Adelaide, South Australia, 5000, Australia

  • Royal Melbourne Hospital

    RECRUITING

    Melbourne, Victoria, Australia

  • SOLUMED Centrum Medyczne

    RECRUITING

    Poznan, Greater Poland Voivodeship, 60-529, Poland

  • Sjaellands Universitets hospitall Koge

    WITHDRAWN

    Køge, Region Sjælland, 4600, Denmark

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

    RECRUITING

    Szczecin, West Pomerianian, 71-685, Poland

  • Svendborg Hospital

    WITHDRAWN

    Svendborg, Denmark

  • TLC Clinical Research Inc - Los Angeles

    WITHDRAWN

    Los Angeles, California, 90048, United States

  • The Alfred Hospital

    RECRUITING

    Melbourne, Victoria, 3004, Australia

  • The Queen Elizabeth Hospital

    RECRUITING

    Woodville, South Australia, 5011, Australia

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

    RECRUITING

    Toronto, Ontario, Canada

  • Twoja Przychodnia-Centrum Medyczne Opole

    WITHDRAWN

    Opole, Poland

  • ULB Hopital Erasme

    RECRUITING

    Brussels, 1070, Belgium

  • UZ Leuven-University Hospital Gasthuisberg

    RECRUITING

    Leuven, Flemish Brabant, 3000, Belgium

  • Universitaetsklinikum Schleswig-Holstein (UKSH)- Campus Kiel

    RECRUITING

    Kiel, Schleswig-Holstein, 24105, Germany

  • Universitats Klinikum Freiburg

    WITHDRAWN

    Freiburg im Breisgau, Germany

  • Universitatsklinikum Augsburg

    NOT_YET_RECRUITING

    Augsburg, Bavaria, 86156, Germany

  • Universitatsklinkum Frankfurt - Goethe Universitat

    WITHDRAWN

    Frankfurt am Main, Hesse, 60590, Germany

  • University College London Hospitals NHS Foundation Trust

    RECRUITING

    London, NW1 2BU, United Kingdom

  • University Hospital Ghent

    RECRUITING

    Ghent, East Flanders, 9000, Belgium

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

    RECRUITING

    Edmonton, Alberta, T6G 2X8, Canada

  • University of Calgary

    RECRUITING

    Calgary, Alberta, T2N 4Z6, Canada

  • VITAZ - AZ Nikolaas

    RECRUITING

    Sint-Niklaas, Antwerpen, 9100, Belgium

  • Viable Clinical Research - Bridgewater

    RECRUITING

    Bridgewater, Nova Scotia, B4V 3N2, Canada

  • Vita Longa Sp. z o.o.

    RECRUITING

    Katowice, Silesian, 40-748, Poland

  • Vojenska nemocnice Brno

    NOT_YET_RECRUITING

    Brno, South Moravian, 615 00, Czechia

  • WIP Warsaw IBD Point Profesor Kierkus

    RECRUITING

    Warsaw, Masovia, 04-501, Poland

  • Western General Hospital

    NOT_YET_RECRUITING

    Edinburgh, EH4 2XU, United Kingdom

More trials for these conditions

Other studies related to the condition(s) this trial covers.