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Ulcerative colitis study aims to pinpoint the perfect treatment goal

NCT ID NCT04259138

Knowledge-focused 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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 11, 2026 · Updated 2 times

Summary

This study looks at 672 people with active ulcerative colitis to find the best treatment target. Participants are split into three groups: one aiming for symptom relief only, another for symptom plus endoscopic healing, and a third for symptom, endoscopic, and microscopic healing. The goal is to see which target leads to fewer disease complications over time.

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

672 people

The number who actually took part.

Started

Feb 2020

Finished

Apr 2026

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 years and older

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. Age ≥ 18 years. 2. Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria. 3. Moderately to severely active UC with a Mayo rectal bleeding subscore ≥ 1 and a MES ≥ 2, with minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using central endoscopic imaging system. 4. Ability of participant to participate fully in all aspects of this clinical trial. 5. Written informed consent must be obtained and documented. 6. Agree not to participate in an investigational trial for the duration of the trial (observation or other noninterventional trials may be permitted at the discretion of the investigator). 7. Negative standard of care tuberculosis (TB) test and hepatitis B and C test prior to randomization unless negative results available from within 12 months prior. 8. A male participant who is nonsterilized\* and sexually active with a female partner of childbearing potential\* agrees to use adequate contraception\* from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. 9. A female participant of childbearing potential\* who is sexually active with a nonsterilized\* male partner agrees to use routinely adequate contraception\* from signing of informed consent throughout the duration of the study and for 18 weeks after last dose. 10. Up to date with colorectal carcinoma surveillance according to local standards and guidelines. If a subject is not up to date at screening, a standard of care surveillance assessment may be performed during the screening period. 11. Participants who are not responding to their existing treatment for UC (Netherlands-specific criterion). Exclusion Criteria: 1. Participants who have historically failed (i.e., had an inadequate response with, lost response to, or were intolerant to) 2 or more compounds or classes of advanced therapeutic options (biologics or small molecules; e.g., anti-TNFs, ustekinumab, or tofacitinib) for the treatment of their UC. 2. Current or previous treatment with vedolizumab, etrolizumab, or natalizumab. 3. Topical therapy (corticosteroid or 5-aminosalicylate \[5-ASA\]) use within 2 weeks prior to screening endoscopy. 4. Change to oral corticosteroid dosing within 2 weeks prior to randomization or a corticosteroid dose of \> 30 mg of prednisone or equivalent at randomization. 5. Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis. 6. Short gut syndrome. 7. Positive stool culture for or active Clostridioides difficile infection (as demonstrated by positive toxin and/or antigen). 8. Known hepatitis B or C infection. If a negative test result is available in the 12 months prior to randomization, retesting is not required. 9. Known active or latent 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. 10. Received any investigational drug within 30 days prior to randomization/target assignment. 11. Serious underlying disease other than UC 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 (such as history of malignancies, major neurological disorders, or any unstable or uncontrolled medical disorder). 12. 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. 13. The participant has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization. 14. Hypersensitivity to any excipient of vedolizumab. 15. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection. 16. History of HIV or positive test at screening (Italy-specific criterion). 17. Any other contraindication(s)to vedolizumab (Italy-specific criterion). 18. If female, the participant is pregnant or lactating or intending to become pregnant before, during, or within 18 weeks after the last dose; or intending to donate ova during such time period. 19. If male, the participant intends to donate sperm during the course of this study or for 18 weeks after the last dose. 20. Vaccination with a live or live-attenuated vaccine within 4 weeks prior to randomization, or planned vaccination during conduct of the study, except vaccination for coronavirus disease of 2019 (COVID-19).

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Conditions

The condition(s) this trial relates to.

ulcerative colitis

As listed by the trial registrant

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

Colitis ulcerative

Contacts and locations

Locations

  • ABP Research Services Corp.

    Oakville, Ontario, L6L 5L7, Canada

  • Amsterdam UMC - Academisch Medisch Centrum

    Amsterdam, North Holland, 1081 HV, Netherlands

  • Atrium Health (Carolinas HealthCare)

    Charlotte, North Carolina, 28204, United States

  • Azienda Ospedaliera - Polyclinico Sant'Orsola-Malpighi

    Bologna, Emilia-Romagna, 40138, Italy

  • Azienda Ospedaliera di Padova

    Padova, Padua, 35128, Italy

  • Barrie GI Associates Inc.

    Barrie, Ontario, L4M 7G1, Canada

  • Barts Health NHS Trust - Royal London Hospital

    London, E1 1BB, United Kingdom

  • Barts Health NHS Trust / Whipps Cross University Hospital

    Leytonstone, E11 1NR, United Kingdom

  • CH Saint Etienne Hopital Nord

    Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42055, France

  • CHRU De Nancy - Hopital de Brabois

    Vandœuvre-lès-Nancy, Grand Est, 54500, France

  • CHRU Montpellier - Hopital Saint Eloi

    Montpellier, Occitanie, 34295, France

  • CHRU de Lille - Hopital Claude Huriez

    Lille, Hauts-de-France, 59037, France

  • CHU Besançon - Hôpital Jean Minjoz

    Besançon, Bourgogne-Franche-Comté, 25000, France

  • CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud

    Pessac, New Aquitaine, 33604, France

  • Catharina Hospital

    Eindhoven, North Brabant, 5623 EJ, Netherlands

  • City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU

    Zaporizhzhya, 69065, Ukraine

  • Digestive Health Partners - Asheville Gastroenterology Associate

    Asheville, North Carolina, 28801, United States

  • Dniepropetrovsk State Medical Academy

    Dnipro, Ukraine

  • ETZ Hospital Tilburg

    Tilburg, North Brabant, 5022 GC, Netherlands

  • Endoskopia Sp. z.o.o.

    Sopot, Pomeranian Voivodeship, 81-756, Poland

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

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

  • GIRI (GI Research Institute)

    Vancouver, British Columbia, V6Z 2K5, Canada

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, Lesser Poland Voivodeship, 31009, Poland

  • Gomel Regional Clinical Hospital

    Homyel, Homiel, 246029, Belarus

  • Hampshire Hospitals NHS Foundation Trust - The Royal Hampshire County Hospital

    Winchester, Hampshire, SO22 5DG, United Kingdom

  • Hull & East Yorkshire NHS Trust

    Hull, Yorkshire, HU3 2JZ, United Kingdom

  • Icahn School of Medicine at Mt Sinai Hospital

    New York, New York, 10029, United States

  • Imelda Ziekenhuis Bonheiden

    Bonheiden, Antwerp, 2820, Belgium

  • Istituto Clinico Humanitas

    Rozzano, Milan, 20089, Italy

  • LHSC - Victoria Hospital

    London, Ontario, N6A 5W9, Canada

  • London Health Sciences Centre - University Campus

    London, Ontario, N6A 5A5, Canada

  • McGill University Health Centre (MUHC) Montreal General Hospital

    Montreal, Quebec, H3G 1A4, Canada

  • McMaster University Medical Centre

    Hamilton, Ontario, L8S 4L8, Canada

  • New York-Presbyterian/Weill Cornell Medical Center

    New York, New York, 10065, United States

  • Oddział Gastroenterologiczny SP ZOZ w Łęcznej

    Łęczna, 21-010, Poland

  • Odesa Regional Clinical Hospital

    Odesa, Ukraine

  • Ospedale San Raffaele S.r.I.

    Milan, Milan, 20132, Italy

  • Oxford University Hospitals NHS Foundation - John Radcliffe Hospital

    Headington, Oxford, OX39DU, United Kingdom

  • Policlinico Universitario Agostino Gemelli

    Roma, Rome, 00-168, Italy

  • Radboud University Nijmegen Medical Centre

    Nijmegen, Gelderland, 6525 GA, Netherlands

  • Russells Hall Hospital

    Dudley, West Midlands, DY1 2HQ, United Kingdom

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

    Szczecin, West Pomeranian Voivodeship, 71-685, Poland

  • St. Joseph Mercy Hospital/Huron Gastroenterology Associates

    Ypsilanti, Michigan, 48197, United States

  • Szpital Miejski Sw. Jana Pawla II w Elblagu

    Elblag, 82300, Poland

  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszcz

    Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland

  • Taunton Surgical Centre

    Oshawa, Ontario, L1J 0C7, Canada

  • Ternopil City Communal Emergency Medical Care Hosp

    Ternopil, Ukraine

  • Toronto Immune and Digestive Health Institute (TIDHI)

    Toronto, Ontario, M6A 3B4, Canada

  • UZ Leuven - University Hospital Gasthuisberg

    Leuven, Flemish Brabant, 3000, Belgium

  • University Hospital Ghent

    Ghent, East Flanders, 9000, Belgium

  • University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elizabeth Hospital Birmingham

    Birmingham, West Midlands, B15 2GW, United Kingdom

  • University of Calgary

    Calgary, Alberta, T2N 4Z6, Canada

  • University of Nottingham NHS Trust

    Nottingham, NG7 2UH, United Kingdom

  • Uzhhorod National University

    Uzhhorod, Ukraine

  • Vinnytsia City Clinical Hospital #1, Dept of Gastroenterology

    Vinnytsia, Ukraine

  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital

    Vinnytsia, Ukraine

  • Vitebsk Regional Clinical Hospital

    Vitebsk, Vitebsk Oblast, 210037, Belarus

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, Masovian Voivodeship, 00-72, Poland

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