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CompletedNCT04259138VERDICTUpdated Sep 10, 2026

Determination of the Optimal Treatment Target in Ulcerative Colitis

A Phase 4 interventional study of Treatment Algorithm A and Treatment Algorithm B in Colitis, Ulcerative, sponsored by Alimentiv Inc.. Completed at 58 sites in 10 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-10.

Sponsored by Alimentiv Inc. · Phase 4, Interventional, and Treatment

Phase
Phase 4
Study type
Interventional
Enrollment
672
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

Disease activity and response to therapy in ulcerative colitis (UC) can be assessed by a range of endpoints including symptoms, endoscopic mucosal activity, histological disease activity, and biomarkers. This study aims to determine the optimal treatment target, which is a research priority for the management of UC both to inform clinical practice and to help inform regulatory endpoints and targets for drug development.

Participants with active UC will be randomized in a 5:4:1 (initially 2:3:5) ratio to 1 of 3 groups, each with a different treatment target. Treatment targets will be defined as:

  • Group 1: corticosteroid-free symptomatic remission
  • Group 2: corticosteroid-free endoscopic + symptomatic remission
  • Group 3: corticosteroid-free histological + endoscopic + symptomatic remission

An interim analysis was performed to assess the proportion of subjects that reached their assigned treatment target after 50 subjects in each group had reached the first 32-week assessment. The interim analysis and projections made based on target achievement rates for all subjects included in the interim analysis resulted in a recommendation to adjust the randomization ratio from 2:3:5 to 5:4:1 for Groups 1, 2 and 3 respectively as of May 5th, 2023. This change was necessary in order to complete the study with approximately 100 subjects achieving treatment target within each group.

02

Conditions studied

  • Colitis, Ulcerative

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03

In context

Colitis, Ulcerative

1,853 studies on the registry are indexed under Colitis, Ulcerative; 472 are open to participants now.

This study's enrollment of 672 is above the median of 70 across 1,236 interventional studies indexed under Colitis, Ulcerative.

Browse Colitis, Ulcerative studies →

Lead sponsor

Alimentiv Inc. is the lead sponsor of 12 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 must be obtained and documented.
  6. Agree not to participate in an 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 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 * agrees to use adequate * 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

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 ( 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 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 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 , 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. to any of vedolizumab.
  15. Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
  16. History of or positive test at screening (Italy-specific criterion).
  17. Any other (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 within 4 weeks prior to randomization, or planned vaccination during conduct of the study, except vaccination for coronavirus disease of 2019 (COVID-19).
Terms in these criteria, in plain language(12)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Hepatitis B tests

Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.

Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Live vaccines

Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.

05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
672 participants (actual)

Study arms

  • Other
    Symptomatic remission

    Treatment target defined as achievement of corticosteroid-free symptomatic remission.

    Biological: Treatment Algorithm A · Biological: Treatment Algorithm B · Biological: Treatment Algorithm C

  • Other
    Symptomatic and endoscopic remission

    Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission.

    Biological: Treatment Algorithm A · Biological: Treatment Algorithm B · Biological: Treatment Algorithm C

  • Other
    Symptomatic, endoscopic and histological remission

    Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission plus histological remission.

    Biological: Treatment Algorithm A · Biological: Treatment Algorithm B · Biological: Treatment Algorithm C

Interventions

  • BiologicalTreatment Algorithm A

    Participants who are not on UC treatment at screening (or who have only used topical therapy) will require standard first-line therapy. Either oral 5-ASA and/or immunosuppressive (azathioprine, 6-mercaptopurine, or methotrexate), with optional oral corticosteroid up to a maximum of 30 mg or prednisone or equivalent, will be initiated.

    Also known as: vedolizumab

  • BiologicalTreatment Algorithm B

    Participants who are taking oral 5-ASA, immunosuppressive (azathioprine, 6-mercaptopurine, methotrexate), and/or oral corticosteroid at screening will follow the treatment algorithm. Participants will change to intravenous vedolizumab therapy. Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm.

    Also known as: vedolizumab

  • BiologicalTreatment Algorithm C

    Participants who are taking a TNFα antagonist (infliximab, golimumab, or adalimumab), tofacitinib, or ustekinumab therapy at screening will follow the treatment algorithm. Participants will change to intravenous vedolizumab therapy. Participants will be assessed to determine it remission target is achieved at weeks 16, 32 and 48. If the participant has achieved their treatment target, they will continue that line of therapy. If the participant has not achieved their treatment target, treatment and/or dose escalation will be administered according to the algorithm.

    Also known as: vedolizumab

06

What researchers measure

Primary outcomes

  1. Difference in Time to UC-related Complication Between Treatment Target Groups 1 and 3

    Time to UC-related complication starting when a participant reaches their assigned treatment target, compared between treatment target groups 1 and 3.

    Time frame: From date of treatment target achievement until date of first UC-related complication until end of study (Week 96), whichever came first

Secondary outcomes

  1. Difference in Time to UC-related Complication Compared Between Treatment Target Groups 1 and 2.

    Time to UC-related complication starting when a participant reaches their assigned treatment target, compared between treatment target groups 1 and 2.

    Time frame: From date of treatment target achievement until date of first UC-related complication until end of study (Week 96), whichever came first

  2. Difference in Time to UC-related Complication Compared Between Treatment Target Groups 2 and 3.

    Time to UC-related complication starting when a participant reaches their assigned treatment target, compared between treatment target groups 2 and 3.

    Time frame: From date of treatment target achievement until date of first UC-related complication until end of study (Week 96), whichever came first

  3. Difference in time to UC-related complication compared between subgroups

    Time to UC-related complication compared between subgroups on and off corticosteroids at the time of achieving other relevant components of the treatment target.

    Time frame: From date of treatment target achievement until date of first UC-related complication until end of study (Week 96), whichever came first

  4. Difference in Time to Achieve Treatment Target

    Time taken to achieve the respective targets among the randomized groups. Time will be censored for subjects who do not achieve their assigned target by Week 48.

    Time frame: up to 96 weeks

  5. Fecal Calprotectin Levels

    Change in fecal calprotectin levels from baseline to Weeks 8, 16, 32, 48, and 96.

    Time frame: Baseline, weeks 8, 16, 32, 48, and 96.

  6. C-Reactive Protein Concentration

    Change in C-Reactive Protein concentration from baseline to Weeks 8, 16, 32, 48, 64, 80, and 96.

    Time frame: Baseline, weeks 8, 16, 32, 48, 64, 80, and 96

  7. Difference in time to UC-related complication (as in the primary outcome and secondary outcomes 2 and 3)

    Time to UC-related complication (as in the primary outcome and secondary outcomes 2 and 3) in the subgroup of subjects who exclusively reach their assigned target and not a higher target by Week 48.

    Time frame: Up to week 96

  8. Evaluate the time to each type of UC-related complication

    Evaluate, across the 3 target achievement groups, the time to each type of UC-related complication that comprises the primary endpoint.

    Time frame: Up to week 96

  9. Assess the effect of treatment(s) on UC-related complications

    Assess the effect of treatment(s) on UC-related complications that is mediated through treatment targets.

    Time frame: Up to week 96

  10. Evaluate change in the UC-100 score from baseline to Weeks 16, 32, 48, and 96

    To evaluate change in the UC-100 score from baseline to Weeks 16, 32, 48, and 96 (both in the full and the achieved-target populations). The UC-100 is a composite disease activity index consisting of clinical, endoscopic, and histological findings.The total UC-100 score ranges from 1 to 100, with higher scores representing more severe disease activity.

    Time frame: Up to week 96

  11. Evaluate changes in the health-related quality of life (HRQoL) using the Inflammatory Bowel Disease Questionnaire (IBDQ)

    To evaluate changes in the health-related quality of life (HRQoL) using the Inflammatory Bowel Disease Questionnaire (IBDQ) from baseline to all follow-up visits.The Inflammatory Bowel Disease Questionnaire (IBDQ) includes 32 questions on 4 domains of health-related quality of life (HRQoL); the total score ranges from 32 and 224, with a higher score signifying a better outcome.

    Time frame: Up to week 96

  12. Evaluate changes in the Work Productivity and Activity Impairment-UC (WPAI-UC) questionnaire

    To evaluate changes in the Work Productivity and Activity Impairment-UC (WPAI-UC) questionnaire from baseline to all follow-up visits.The WPAI-UC (Work Productivity and Activity Impairment Questionnaire) consists of 6 questions that will grade the productivity while the participant is working on a scale from 0 to 10; a higher score signifies a higher impact on work productivity.

    Time frame: Up to week 96

  13. Evaluate the change in Mayo Clinic Score (MCS; and subcomponents including the MES)

    To evaluate the change in Mayo Clinic Score (MCS; and subcomponents including the MES) from baseline to Week 16,32,48 and 96/end of study (EOS). The Mayo Clinic Score for Ulcerative Colitis is a score that ranges from 0 to 12 with higher scores indicating worse severity. The score has four items (Stool Frequency, Rectal Bleeding, Mucosal appearance at endoscopy, Physician rating of disease activity) each rated from 0 to 3, where 3 means highest severity.

    Time frame: Up to week 96

  14. Describe the change in Geboes scores from baseline to baseline to Week 16, 32, 48 and 96/end of study (EOS)

    To describe the change in Geboes scores from baseline to baseline to Week 16, 32, 48 and 96/end of study (EOS). Geboes score is the most commonly used histological score in ulcerative colitis \[UC\] and is divided in 6 grades: architectural changes \[grade 0\], chronic inflammatory infiltrate \[grade 1\], lamina propria neutrophils and eosinophils \[grade 2\], neutrophils in epithelium \[grade 3\], crypt destruction \[grade 4\] and erosions or ulcerations \[grade 5\].

    Time frame: Up to week 96

  15. Describe the change in RHI scores from baseline to all baseline to Week 16, 32, 48 and 96/end of study (EOS)

    To describe the change in RHI scores from baseline to all baseline to Week 16, 32, 48 and 96/end of study (EOS). The Robarts Histopathology Index (RHI) is a validated instrument that measures histological disease activity in ulcerative colitis. The RHI assesses four characteristics of mucosal activity, inflammatory infiltrate, lamina propria neutrophils, neutrophils in epithelium, and erosion or ulceration, all of which are rated on a scale of 0 to 3, with higher scores representing more severe disease activity.

    Time frame: Up to week 96

  16. Describe the change in Nancy Histological Index scores from baseline to baseline to Week 16, 32, 48 and 96/end of study (EOS)

    To describe the change in Nancy Histological Index scores from baseline to baseline to Week 16, 32, 48 and 96/end of study (EOS). The Nancy Histological Index is made up of 3 items: acute inflammatory cell infiltrates, chronic inflammatory cell infiltrates, and the presence of ulceration. Histological disease activity is graded on a 5-point scale; from grade 0 (no histologically significant disease) to grade 4 (severely active disease), with this grade being determined by the scoring algorithm.

    Time frame: Up to week 96

  17. Evaluate the numbers of AEs and SAEs among the 3 randomized groups

    To evaluate the numbers of AEs and SAEs among the 3 randomized groups.

    Time frame: Up to week 96

  18. Validate the Symptoms and Impacts Questionnaire for UC (SIQ-UC) tool in English-fluent subjects

    To validate the Symptoms and Impacts Questionnaire for Ulcerative Colitis (SIQ-UC) tool in English-fluent subjects. SIQ-UC consists of a symptom domain, which includes Gastrointestinal, 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.

    Time frame: Up to week 96

07

Study locations

58 sites
  • St. Joseph Mercy Hospital/Huron Gastroenterology Associates
    Ypsilanti, Michigan 48197, United States
  • Icahn School of Medicine at Mt Sinai Hospital
    New York, New York 10029, United States
  • New York-Presbyterian/Weill Cornell Medical Center
    New York, New York 10065, United States
  • Digestive Health Partners - Asheville Gastroenterology Associate
    Asheville, North Carolina 28801, United States
  • Atrium Health (Carolinas HealthCare)
    Charlotte, North Carolina 28204, United States
  • Gomel Regional Clinical Hospital
    Homyel, Homiel 246029, Belarus
  • Vitebsk Regional Clinical Hospital
    Vitebsk, Vitebsk Oblast 210037, Belarus
  • Imelda Ziekenhuis Bonheiden
    Bonheiden, Antwerp 2820, Belgium
  • University Hospital Ghent
    Ghent, East Flanders 9000, Belgium
  • UZ Leuven - University Hospital Gasthuisberg
    Leuven, Flemish Brabant 3000, Belgium
  • University of Calgary
    Calgary, Alberta T2N 4Z6, Canada
  • GIRI (GI Research Institute)
    Vancouver, British Columbia V6Z 2K5, Canada
  • Barrie GI Associates Inc.
    Barrie, Ontario L4M 7G1, Canada
  • McMaster University Medical Centre
    Hamilton, Ontario L8S 4L8, Canada
  • London Health Sciences Centre - University Campus
    London, Ontario N6A 5A5, Canada
  • LHSC - Victoria Hospital
    London, Ontario N6A 5W9, Canada
  • ABP Research Services Corp.
    Oakville, Ontario L6L 5L7, Canada
  • Taunton Surgical Centre
    Oshawa, Ontario L1J 0C7, Canada
  • Toronto Immune and Digestive Health Institute (TIDHI)
    Toronto, Ontario M6A 3B4, Canada
  • McGill University Health Centre (MUHC) Montreal General Hospital
    Montreal, Quebec H3G 1A4, Canada
  • CH Saint Etienne Hopital Nord
    Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes 42055, France
  • CHU Besançon - Hôpital Jean Minjoz
    Besançon, Bourgogne-Franche-Comté 25000, France
  • CHRU De Nancy - Hopital de Brabois
    Vandœuvre-lès-Nancy, Grand Est 54500, France
  • CHRU de Lille - Hopital Claude Huriez
    Lille, Hauts-de-France 59037, France
  • CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud
    Pessac, New Aquitaine 33604, France
  • CHRU Montpellier - Hopital Saint Eloi
    Montpellier, Occitanie 34295, France
  • Azienda Ospedaliera - Polyclinico Sant'Orsola-Malpighi
    Bologna, Emilia-Romagna 40138, Italy
  • Ospedale San Raffaele S.r.I.
    Milan, Milan 20132, Italy
  • Istituto Clinico Humanitas
    Rozzano, Milan 20089, Italy
  • Azienda Ospedaliera di Padova
    Padova, Padua 35128, Italy
  • Policlinico Universitario Agostino Gemelli
    Roma, Rome 00-168, Italy
  • Radboud University Nijmegen Medical Centre
    Nijmegen, Gelderland 6525 GA, Netherlands
  • Catharina Hospital
    Eindhoven, North Brabant 5623 EJ, Netherlands
  • ETZ Hospital Tilburg
    Tilburg, North Brabant 5022 GC, Netherlands
  • Amsterdam UMC - Academisch Medisch Centrum
    Amsterdam, North Holland 1081 HV, Netherlands
  • Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszcz
    Bydgoszcz, Kuyavian-Pomeranian Voivodeship 85-168, Poland
  • GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.
    Torun, Kuyavian-Pomeranian Voivodeship 87-100, Poland
  • Gabinet Endoskopii Przewodu Pokarmowego
    Krakow, Lesser Poland Voivodeship 31009, Poland
  • WIP Warsaw IBD Point Profesor Kierkus
    Warsaw, Masovian Voivodeship 00-72, Poland
  • Endoskopia Sp. z.o.o.
    Sopot, Pomeranian Voivodeship 81-756, Poland
  • Sonomed Sp. z o.o. - Centrum Medyczne
    Szczecin, West Pomeranian Voivodeship 71-685, Poland
  • Szpital Miejski Sw. Jana Pawla II w Elblagu
    Elblag, 82300, Poland
  • Oddział Gastroenterologiczny SP ZOZ w Łęcznej
    Łęczna, 21-010, Poland
  • Dniepropetrovsk State Medical Academy
    Dnipro, Ukraine
  • Odesa Regional Clinical Hospital
    Odesa, Ukraine
  • Ternopil City Communal Emergency Medical Care Hosp
    Ternopil, Ukraine
  • Uzhhorod National University
    Uzhhorod, Ukraine
  • Vinnytsia City Clinical Hospital #1, Dept of Gastroenterology
    Vinnytsia, Ukraine
  • Vinnytsia M.I. Pyrohov Regional Clinical Hospital
    Vinnytsia, Ukraine
  • City Clinical Hospital #9 Dept of Gastrosurgery SI Zaporizhzhia MA of PGE of MoHU
    Zaporizhzhya, 69065, Ukraine
  • Hampshire Hospitals NHS Foundation Trust - The Royal Hampshire County Hospital
    Winchester, Hampshire SO22 5DG, United Kingdom
  • Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
    Headington, Oxford OX39DU, United Kingdom
  • University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elizabeth Hospital Birmingham
    Birmingham, West Midlands B15 2GW, United Kingdom
  • Russells Hall Hospital
    Dudley, West Midlands DY1 2HQ, United Kingdom
  • Hull & East Yorkshire NHS Trust
    Hull, Yorkshire HU3 2JZ, United Kingdom
  • Barts Health NHS Trust / Whipps Cross University Hospital
    Leytonstone, E11 1NR, United Kingdom
  • Barts Health NHS Trust - Royal London Hospital
    London, E1 1BB, United Kingdom
  • University of Nottingham NHS Trust
    Nottingham, NG7 2UH, United Kingdom
08

References and documents

Publications

  • Jairath V, Zou G, Wang Z, Adsul S, Colombel JF, D'Haens GR, Freire M, Moran GW, Peyrin-Biroulet L, Sandborn WJ, Sebastian S, Travis S, Vermeire S, Radulescu G, Sigler J, Hanzel J, Ma C, Sedano R, McFarlane SC, Arya N, Beaton M, Bossuyt P, Danese S, Green D, Harlan W 3rd, Horynski M, Klopocka M, Petroniene R, Silverberg MS, Wolanski L, Feagan BG. Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial. BMJ Open Gastroenterol. 2024 Feb 8;11(1):e001218. doi: 10.1136/bmjgast-2023-001218. PubMed 38336367 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Feb 2020 to primary completion in Apr 2026, 73 months.

Of 48 non-industry phase 4 interventional studies under Colitis, Ulcerative, half reached primary completion within 56 months of starting (the median), counting those still running; a quarter within 33 and three quarters within 66. This study's 73 months is above that.

Counting every sponsor, half of 63 studies reached it within 43 months; a quarter within 25 and three quarters within 63.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2020
First posted
Feb 6, 2020
StartActual
Feb 18, 2020
Primary completionActual
Apr 13, 2026
CompletionActual
Apr 13, 2026
Last update
Sep 10, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Sep 10, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04259138
Lead sponsor
Alimentiv Inc.
Collaborators
Takeda Development Center Americas, Inc.
Responsible party
Sponsor
First posted
Feb 6, 2020
Start date
Feb 18, 2020
Primary completion
Apr 13, 2026
Completion
Apr 13, 2026
Last update
Sep 10, 2026

Study contacts

Vipul Jairath, MD
principal investigator · Alimentiv Inc.

Oversight

Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Discussion

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Studies of the drug tested here: Vedolizumab

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