Determination of the Optimal Treatment Target in Ulcerative Colitis
NCT ID: NCT04259138
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE4
672 participants
INTERVENTIONAL
2020-02-18
2026-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
SINGLE
Study Groups
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Symptomatic remission
Treatment target defined as achievement of corticosteroid-free symptomatic remission.
Treatment 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.
Treatment 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.
Treatment 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.
Symptomatic and endoscopic remission
Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission.
Treatment 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.
Treatment 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.
Treatment 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.
Symptomatic, endoscopic and histological remission
Treatment target defined as achievement of corticosteroid-free symptomatic remission plus endoscopic remission plus histological remission.
Treatment 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.
Treatment 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.
Treatment 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.
Interventions
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Treatment 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.
Treatment 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.
Treatment 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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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).
18 Years
ALL
No
Sponsors
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Takeda Development Center Americas, Inc.
INDUSTRY
Alimentiv Inc.
OTHER
Responsible Party
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Principal Investigators
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Vipul Jairath, MD
Role: PRINCIPAL_INVESTIGATOR
Alimentiv Inc.
Locations
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St. Joseph Mercy Hospital/Huron Gastroenterology Associates
Ypsilanti, Michigan, United States
Icahn School of Medicine at Mt Sinai Hospital
New York, New York, United States
New York-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
Digestive Health Partners - Asheville Gastroenterology Associate
Asheville, North Carolina, United States
Atrium Health (Carolinas HealthCare)
Charlotte, North Carolina, United States
Gomel Regional Clinical Hospital
Homyel, Homiel, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk, Vitebsk Oblast, Belarus
Imelda Ziekenhuis Bonheiden
Bonheiden, Antwerp, Belgium
University Hospital Ghent
Ghent, East Flanders, Belgium
UZ Leuven - University Hospital Gasthuisberg
Leuven, Flemish Brabant, Belgium
University of Calgary
Calgary, Alberta, Canada
GIRI (GI Research Institute)
Vancouver, British Columbia, Canada
Barrie GI Associates Inc.
Barrie, Ontario, Canada
McMaster University Medical Centre
Hamilton, Ontario, Canada
London Health Sciences Centre - University Campus
London, Ontario, Canada
LHSC - Victoria Hospital
London, Ontario, Canada
ABP Research Services Corp.
Oakville, Ontario, Canada
Taunton Surgical Centre
Oshawa, Ontario, Canada
Toronto Immune and Digestive Health Institute (TIDHI)
Toronto, Ontario, Canada
McGill University Health Centre (MUHC) Montreal General Hospital
Montreal, Quebec, Canada
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France
CHU Besançon - Hôpital Jean Minjoz
Besançon, Bourgogne-Franche-Comté, France
CHRU De Nancy - Hopital de Brabois
Vandœuvre-lès-Nancy, Grand Est, France
CHRU de Lille - Hopital Claude Huriez
Lille, Hauts-de-France, France
CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud
Pessac, Nouvelle-Aquitaine, France
CHRU Montpellier - Hopital Saint Eloi
Montpellier, Occitanie, France
Azienda Ospedaliera - Polyclinico Sant'Orsola-Malpighi
Bologna, Emilia-Romagna, Italy
Ospedale San Raffaele S.r.I.
Milan, Milan, Italy
Istituto Clinico Humanitas
Rozzano, Milan, Italy
Azienda Ospedaliera di Padova
Padua, Padua, Italy
Policlinico Universitario Agostino Gemelli
Roma, Rome, Italy
Radboud University Nijmegen Medical Centre
Nijmegen, Gelderland, Netherlands
Catharina Hospital
Eindhoven, North Brabant, Netherlands
ETZ Hospital Tilburg
Tilburg, North Brabant, Netherlands
Amsterdam UMC - Academisch Medisch Centrum
Amsterdam, North Holland, Netherlands
Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszcz
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
GASTROMED - Kopon, Zmudzinski I Wspolnicy Sp.j.
Torun, Kuyavian-Pomeranian Voivodeship, Poland
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Lesser Poland Voivodeship, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, Poland
Endoskopia Sp. z.o.o.
Sopot, Pomeranian Voivodeship, Poland
Sonomed Sp. z o.o. - Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, Poland
Szpital Miejski Sw. Jana Pawla II w Elblagu
Elblag, , Poland
Oddział Gastroenterologiczny SP ZOZ w Łęcznej
Łęczna, , 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
Zaporizhzhia, , Ukraine
Hampshire Hospitals NHS Foundation Trust - The Royal Hampshire County Hospital
Winchester, Hampshire, United Kingdom
Oxford University Hospitals NHS Foundation - John Radcliffe Hospital
Headington, Oxford, United Kingdom
University Hospitals Birmingham NHS Foundation Trust (UHB) - Queen Elizabeth Hospital Birmingham
Birmingham, West Midlands, United Kingdom
Russells Hall Hospital
Dudley, West Midlands, United Kingdom
Hull & East Yorkshire NHS Trust
Hull, Yorkshire, United Kingdom
Barts Health NHS Trust / Whipps Cross University Hospital
Leytonstone, , United Kingdom
Barts Health NHS Trust - Royal London Hospital
London, , United Kingdom
University of Nottingham NHS Trust
Nottingham, , United Kingdom
Countries
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References
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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.
Related Links
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Determining the optimal treatment target in patients with ulcerative colitis: rationale, design, protocol and interim analysis for the randomised controlled VERDICT trial
Other Identifiers
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2019-002485-12
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
RP1706
Identifier Type: -
Identifier Source: org_study_id
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