Determination of the Optimal Treatment Target in Ulcerative Colitis

Study Purpose

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 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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Diagnosis of UC confirmed by clinical, endoscopic, and histological evidence prior to screening as per standard criteria.
  • - Moderately to severely active UC with a Mayo rectal bleeding subscore ≥ 1 and a Mayo endoscopic subscore (MES) ≥ 2, with minimum disease extent of 15 cm and objective evidence of inflammation that can be visualized using central endoscopic imaging system.
  • - Ability of subject to participate fully in all aspects of this clinical trial.
  • - Written informed consent must be obtained and documented.
  • - Agree not to participate in an investigational trial for the duration of the trial (observation trials without investigational product may be permitted at the discretion of the investigator) - Willing to perform a standard of care tuberculosis (TB) test and hepatitis B and C test prior to starting any biologic drug during the study, unless negative results available from within 12 months prior.
  • - A male subject 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.
  • - A female subject 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.
  • - 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.
  • - Subjects who are not responding to their existing treatment for UC (Netherlands-specific criterion).

Exclusion Criteria:

  • - Subjects 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.
  • - Current or previous treatment with vedolizumab, ertrolizumab, or natalizumab.
  • - Topical therapy (corticosteroid or 5-aminosalicylate [5-ASA]) use within 2 weeks prior to screening endoscopy.
  • - Change to oral corticosteroid dosing within 2 weeks prior to screening.
  • - Known diagnosis of CD, indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, or microscopic colitis.
  • - Short gut syndrome.
  • - Positive stool culture for or active Clostridioides difficile infection (as demonstrated by positive toxin and/or antigen) - Known 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 TB.
If a negative test results is available in the 12 months prior to randomization, confirmatory testing is not required.
  • - Received any investigational drug within 30 days prior to randomization/target assignment.
  • - Serious underlying disease other than UC that in the opinion of the investigator may interfere with the subject's ability to participate fully in the study or would compromise subject safety (such as history of malignancies, major neurological disorders, or any unstable or uncontrolled medical disorder) - History of alcohol or drug abuse that in the opinion of the investigator may interfere with the subject's ability to comply with the study procedures.
  • - The subject has active cerebral/meningeal disease, signs, symptoms, or any history of progressive multifocal leukoencephalopathy (PML) prior to randomization.
  • - Hypersensitivity to any excipient of vedolizumab .
  • - Active severe infection such as sepsis, cytomegalovirus, listeriosis, or opportunistic infection.
  • - History of HIV or positive test at screening (Italy-specific criterion).
  • - Any other contraindication(s)to vedolizumab (Italy-specific criterion).
  • - If female, the subject 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.
  • - If male, the subject intends to donate sperm during the course of this study or for 18 weeks after the last dose.
  • - 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).

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04259138
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 4
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Alimentiv Inc.
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Vipul Jairath, MD
Principal Investigator Affiliation Alimentiv Inc.
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, Industry
Overall Status Recruiting
Countries Belgium, Canada, France, Netherlands, Poland, Ukraine, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Colitis, Ulcerative
Arms & Interventions

Arms

Other: Symptomatic remission

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

Other: Symptomatic and endoscopic remission

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

Other: Symptomatic, endoscopic and histological remission

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

Interventions

Biological: - Treatment Algorithm A

Participants who are treatment-naïve at randomization will follow treatment algorithm A. Participants, upon entry into the study, will require standard first-line therapy. Either oral 5-ASA and/or immunosuppressive (with optional oral corticosteroid in combination) will be initiated. 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.

Biological: - Treatment Algorithm B

Participants who are taking non-biologic UC therapies at randomization will follow treatment algorithm B. 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.

Biological: - Treatment Algorithm C

Participants who are taking anti-TNF, tofacitinib or ustekinumab therapy at randomization will follow treatment algorithm C. 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ypsilanti, Michigan

Status

Recruiting

Address

Huron Gastroenterology Associates - Center for Digestive Care

Ypsilanti, Michigan, 48197

Site Contact

Andrea Shah

verdictcsm@alimentiv.com

+1 858-768-2260

New York, New York

Status

Recruiting

Address

Icahn School of Medicine at Mt Sinai Hospital

New York, New York, 10029

Site Contact

Sari Feldman

verdictcsm@alimentiv.com

+1 858-768-2260

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10065

Site Contact

Fatiha Chabouni

verdictcsm@alimentiv.com

646-697-0985

Asheville, North Carolina

Status

Recruiting

Address

Asheville Gastroenterology Associates, PA

Asheville, North Carolina, 28801

Site Contact

Kelly Roberts

verdictcsm@alimentiv.com

+1 858-768-2260

Atrium Health (Carolinas HealthCare), Charlotte, North Carolina

Status

Recruiting

Address

Atrium Health (Carolinas HealthCare)

Charlotte, North Carolina, 28204

Site Contact

Jodi Macko

verdictcsm@alimentiv.com

+1 858-768-2260

International Sites

Imelda Ziekenhuis Bonheiden, Bonheiden, Antwerp, Belgium

Status

Recruiting

Address

Imelda Ziekenhuis Bonheiden

Bonheiden, Antwerp, 2820

Site Contact

Ils Van De Schoot

verdictcsm@alimentiv.com

+1 858-768-2260

University Hospital Ghent, Ghent, East Flanders, Belgium

Status

Recruiting

Address

University Hospital Ghent

Ghent, East Flanders, 9000

Site Contact

Lien Van Den Bossche

verdictcsm@alimentiv.com

+1 858-768-2260

Leuven, Flemish Brabant, Belgium

Status

Recruiting

Address

UZ Leuven - University Hospital Gasthuisberg

Leuven, Flemish Brabant, 3000

Site Contact

Julie Thijs

verdictcsm@alimentiv.com

+1 858-768-2260

University of Calgary, Calgary, Alberta, Canada

Status

Recruiting

Address

University of Calgary

Calgary, Alberta, T2N 4Z6

Site Contact

Nima Hamidi

verdictcsm@alimentiv.com

+1 858-768-2260

GIRI (GI Research Institute), Vancouver, British Columbia, Canada

Status

Recruiting

Address

GIRI (GI Research Institute)

Vancouver, British Columbia, V6Z 2K5

Site Contact

Mari Chris Colman

verdictcsm@alimentiv.com

+1 858-768-2260

Barrie GI Associates Inc., Barrie, Ontario, Canada

Status

Recruiting

Address

Barrie GI Associates Inc.

Barrie, Ontario, L4M 7G1

Site Contact

Colayna Harris-Mailloux

verdictcsm@alimentiv.com

+1 858-768-2260

London, Ontario, Canada

Status

Recruiting

Address

London Health Sciences Centre - University Campus

London, Ontario, N6A 5A5

Site Contact

Heather Prins

verdictcsm@alimentiv.com

+1 858-768-2260

LHSC - Victoria Hospital, London, Ontario, Canada

Status

Recruiting

Address

LHSC - Victoria Hospital

London, Ontario, N6A 5W9

Site Contact

Cindi Wessman

verdictcsm@alimentiv.com

+1 858-768-2260

ABP Research Services Corp., Oakville, Ontario, Canada

Status

Recruiting

Address

ABP Research Services Corp.

Oakville, Ontario, L6L 5L7

Site Contact

Ananya Sahni

verdictcsm@alimentiv.com

+1 858-768-2260

Taunton Surgical Centre, Oshawa, Ontario, Canada

Status

Recruiting

Address

Taunton Surgical Centre

Oshawa, Ontario, L1J 0C7

Site Contact

Alana Carter

verdictcsm@alimentiv.com

+1 858-768-2260

Toronto, Ontario, Canada

Status

Recruiting

Address

Toronto Immune and Digestive Health Institute (TIDHI)

Toronto, Ontario, M6A 3B4

Site Contact

Ajani Jeyakumar

verdictcsm@alimentiv.com

+1 858-768-2260

CH Saint Etienne Hopital Nord, Saint-Priest-en-Jarez, Auvergne-Rhone-Alpes, France

Status

Recruiting

Address

CH Saint Etienne Hopital Nord

Saint-Priest-en-Jarez, Auvergne-Rhone-Alpes, 42055

Site Contact

Nabila Boukhadra

verdictcsm@alimentiv.com

+1 858-768-2260

CHU Besançon - Hôpital Jean Minjoz, Besançon, Bourgogne-Franche-Comte, France

Status

Recruiting

Address

CHU Besançon - Hôpital Jean Minjoz

Besançon, Bourgogne-Franche-Comte, 25000

Site Contact

Fanny Vaurie

verdictcsm@alimentiv.com

+1 858-768-2260

CHRU de Lille - Hopital Claude Huriez, Lille Cedex, Hauts-de-France, France

Status

Recruiting

Address

CHRU de Lille - Hopital Claude Huriez

Lille Cedex, Hauts-de-France, 59037

Site Contact

Audrey Baillon

verdictcsm@alimentiv.com

+1 858-768-2260

PESSAC cedex, Nouvelle-Aquitaine, France

Status

Recruiting

Address

CHU de Bordeaux - Hopital Haut Leveque - Groupe Hospitalier Sud

PESSAC cedex, Nouvelle-Aquitaine, 33604

Site Contact

Cavillon Elodie

verdictcsm@alimentiv.com

+1 858-768-2260

CHRU Montpellier - Hopital Saint Eloi, MONTPELLIER cedex 05, Occitanie, France

Status

Recruiting

Address

CHRU Montpellier - Hopital Saint Eloi

MONTPELLIER cedex 05, Occitanie, 34295

Site Contact

Perrine Rocher

verdictcsm@alimentiv.com

+1 858-768-2260

CHU Nice - Hopital l'Archet II, NICE Cedex 03, Provence-Alpes-Cote d'Azur, France

Status

Withdrawn

Address

CHU Nice - Hopital l'Archet II

NICE Cedex 03, Provence-Alpes-Cote d'Azur, 6202

Amsterdam, North Holland, Netherlands

Status

Recruiting

Address

Amsterdam UMC - Academisch Medisch Centrum

Amsterdam, North Holland, 1105 AZ

Site Contact

Karolien Van Den Broeck

verdictcsm@alimentiv.com

+1 858-768-2260

Catharina Hospital, Eindhoven, Netherlands

Status

Recruiting

Address

Catharina Hospital

Eindhoven, , 5623 EJ

Site Contact

Vincent Peters

verdictcsm@alimentiv.com

+1 858-768-2260

Nijmegen, Netherlands

Status

Recruiting

Address

Radboud University Nijmegen Medical Centre

Nijmegen, , 6525 GA

Site Contact

Cynthia Jansen

verdictcsm@alimentiv.com

+1 858-768-2260

ETZ Hospital Tilburg, Tilburg, Netherlands

Status

Recruiting

Address

ETZ Hospital Tilburg

Tilburg, , 5022 GC

Site Contact

Dominique Bierens-Peters

verdictcsm@alimentiv.com

+1 858-768-2260

Bydgoszcz, Poland

Status

Recruiting

Address

Szpital Uniwersytecki nr 2 im. dr Jana Biziela w Bydgoszcz

Bydgoszcz, , 85-168

Site Contact

Marcin Manerowski

verdictcsm@alimentiv.com

+1 858-768-2260

Elblag, Poland

Status

Recruiting

Address

Szpital Miejski Sw. Jana Pawla II w Elblagu

Elblag, , 82300

Site Contact

Kamila Osak

verdictcsm@alimentiv.com

+1 858-768-2260

Gabinet Endoskopii Przewodu Pokarmowego, Krakow, Poland

Status

Recruiting

Address

Gabinet Endoskopii Przewodu Pokarmowego

Krakow, , 31009

Site Contact

Magdalena Ras

verdictcsm@alimentiv.com

+1 858-768-2260

Endoskopia Sp. z.o.o., Sopot, Poland

Status

Recruiting

Address

Endoskopia Sp. z.o.o.

Sopot, , 81-756

Site Contact

Lidia ZaszczyryńskaInstitute

verdictcsm@alimentiv.com

+1 858-768-2260

Gastromed, Torun, Poland

Status

Recruiting

Address

Gastromed

Torun, , 87-100

Site Contact

Daria Kriks

verdictcsm@alimentiv.com

+1 858-768-2260

Nzoz Vivamed, Warsaw, Poland

Status

Recruiting

Address

Nzoz Vivamed

Warsaw, , 03-580

Site Contact

Magdalena Miecz

verdictcsm@alimentiv.com

+1 858-768-2260

Łęczna, Poland

Status

Recruiting

Address

Oddział Gastroenterologiczny SP ZOZ w Łęcznej

Łęczna, , 21-010

Site Contact

Damian Sowa, MD

verdictcsm@alimentiv.com

+1 858-768-2260

Dniepropetrovsk State Medical Academy, Dnipro, Ukraine

Status

Active, not recruiting

Address

Dniepropetrovsk State Medical Academy

Dnipro, ,

Odesa Regional Clinical Hospital, Odesa, Ukraine

Status

Active, not recruiting

Address

Odesa Regional Clinical Hospital

Odesa, ,

Ternopil, Ukraine

Status

Active, not recruiting

Address

Ternopil City Communal Emergency Medical Care Hosp

Ternopil, ,

Vinnytsia, Ukraine

Status

Active, not recruiting

Address

Vinnytsia City Clinical Hospital #1, Dept of Gastroenterology

Vinnytsia, ,

Vinnytsia, Ukraine

Status

Active, not recruiting

Address

Vinnytsia M.I. Pyrohov Regional Clinical Hospital

Vinnytsia, ,

Zaporizhzhia, Ukraine

Status

Active, not recruiting

Address

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

Zaporizhzhia, , 69065

Uzhhorod National University, Úzhgorod, Ukraine

Status

Active, not recruiting

Address

Uzhhorod National University

Úzhgorod, ,

John Radcliffe Hospital, Oxford, Oxfordshire, United Kingdom

Status

Recruiting

Address

John Radcliffe Hospital

Oxford, Oxfordshire, OX3 9DU

Site Contact

Mary Lucas

verdictcsm@alimentiv.com

+1 858-768-2260

Hull & East Yorkshire NHS Trust, Hull, Yorkshire, United Kingdom

Status

Recruiting

Address

Hull & East Yorkshire NHS Trust

Hull, Yorkshire, HU3 2JZ

Site Contact

Sally Myers

verdictcsm@alimentiv.com

+1 858-768-2260

Leytonstone, United Kingdom

Status

Recruiting

Address

Barts Health NHS Trust / Whipps Cross University Hospital

Leytonstone, , E11 1NR

Site Contact

Ceri Guarnieri

verdictcsm@alimentiv.com

+1 858-768-2260

Royal London Hospital, Barts Health, London, United Kingdom

Status

Recruiting

Address

Royal London Hospital, Barts Health

London, , E3 5QU

Site Contact

Irish Lee

verdictcsm@alimentiv.com

+1 858-768-2260

University of Nottingham NHS Trust, Nottingham, United Kingdom

Status

Recruiting

Address

University of Nottingham NHS Trust

Nottingham, , NG7 2UH

Site Contact

Aleesha Mohanan

verdictcsm@alimentiv.com

+1 858-768-2260