A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Vedolizumab, Upadacitinib, Placebo.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Austria, Belgium, Brazil, Canada +21
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab and Oral Placebo for Induction Followed by Intravenous Vedolizumab Monotherapy for Maintenance in the Treatment of Adults With Moderately to Severely Active Crohn's Disease
Overview
The main aim of this study is to learn whether vedolizumab and upadacitinib given together (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel compared to vedolizumab only (also called monotherapy) in adults with moderately or severely active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and effective DTT is compared to monotherapy for these participants. All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab only (monotherapy) for an additional 40 weeks. During the study, participants will visit their study clinic 15 times.
Detailed description
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderately to severely active CD. The study will look at the efficacy and safety of vedolizumab with and without upadacitinib. The study will enroll approximately 396 patients. Participants will be assigned in a 1:1 ratio to one of the two treatment groups in the 12-weeks Induction Phase:
* Induction Phase: Vedolizumab + Upadacitinib * Induction Phase: Vedolizumab + Placebo
Participants who achieve a Crohn's disease activity index (CDAI) reduction of greater than or equal to (\>=)70 points from baseline at Week 12 will enter the main study Maintenance Phase (40 weeks) of the study to receive vedolizumab monotherapy. Participants will be followed for a further 18-week safety follow-up period up to Week 70.
This multi-center trial will be conducted worldwide. The overall time to participate in this study is approximately 70 weeks.
Interventions
- Drug Vedolizumab
Vedolizumab IV infusion. - Drug Upadacitinib
Upadacitinib over-encapsulated tablets. - Drug Placebo
Upadacitinib matched placebo capsules.
Primary outcome measures
- Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 [Time frame: Week 12]
- Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12 [Time frame: Week 12]
Secondary outcome measures (10)
- Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Based Clinical Remission at Week 12 [Time frame: Week 12]
- Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12 [Time frame: Week 12]
- Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 12 [Time frame: Week 12]
- Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 12 [Time frame: Week 12]
- Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 52 [Time frame: Week 52]
- Percentage of Participants Exhibiting an Endoscopic Response Based on SES-CD at Week 52 [Time frame: Week 52]
- Percentage of Participants Achieving 2-item PRO2 Based Clinical Remission at Week 52 [Time frame: Week 52]
- Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 52 [Time frame: Week 52]
- Percentage of Participants Exhibiting Corticosteroid-free Clinical Remission in Participants who Were Taking Corticosteroids at Baseline Based on the CDAI at Week 52 [Time frame: Week 52]
- Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 52 [Time frame: Week 52]
Eligibility criteria
Inclusion criteria
- The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a histopathology report.
- The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
- The participant has evidence of mucosal inflammation based on the SES-CD: SES-CD score of >=6 (or >=4 for participants with isolated ileal disease), as confirmed by a central reader.
- The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy.
Exclusion criteria
- The participant has a current diagnosis of ulcerative colitis or indeterminate colitis.
- The participant has infection(s) requiring treatment with IV anti-infectives within 30 days prior to baseline or oral/intramuscular anti-infectives within 14 days prior to baseline.
- The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to screening, or ongoing chronic infection.
- The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex.
- The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures; 2 entire missing segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum; fulminant colitis; toxic megacolon; or any other manifestation that might require surgery while enrolled in the study.
- The participant has an ostomy or ileoanal pouch.
- The participant has severe renal impairment, defined as an estimated glomerular filtration rate of <30 milliliters per minute per 1.73 square meters (mL/min/1.73 m\^2).
- The participant has severe (Child-Pugh C) hepatic impairment.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
United States · 19 centers
- UCSD Medical Center — La Jolla
- Keck Medicine Of USC - USC Healthcare Center 1 — Los Angeles
- Peak Gastroenterology Associates — Colorado Springs
- GI PROS, Inc. — Naples
- Orlando Health Ambulatory Care Center — Orlando
- USF Health Morsani Center for Advanced Healthcare — Tampa
- Indiana University (IU) Health University Hospital — Indianapolis
- University of Kentucky — Lexington
- … and 11 more centers
Canada · 9 centers
- Heritage Medical Research Clinic - University Of Calgary — Calgary
- University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre — Winnipeg
- Dalhousie University — Halifax
- Barrie GI Associates — Barrie
- McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI) — Hamilton
- Taunton Surgical Centre-Oshawa Clinic — Oshawa
- Toronto Immune and Digestive Health Institute (TIDHI) — Toronto
- Toronto Digestive Disease Associates — Vaughan
- … and 1 more center
France · 8 centers
- CHU d'Amiens-Picardie - Hopital SUD — Amiens
- Hopital Huriez - CHRU de Lille — Lille
- Chu - Hopital Nord — Marseille
- Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu — Nantes
- Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque — Pessac
- CHU St Etienne Hopital Nord — Saint-Etienne
- Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil — Toulouse
- Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois — Vandœuvre-lès-Nancy
South Korea · 8 centers
Center list to be confirmed — check the primary protocol.
Brazil · 7 centers
- Hospital Universitario Cajuru — Curitiba
- Faculdade de Medicina de Botucatu — Botucatu
- Centro de Estudos Clinico do Interior Paulista - CECIP — Jaú
- Pesquisare Saude — Santo André
- Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filh — Rio de Janeiro
- Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade d — São Paulo
- Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao — São Paulo
Germany · 7 centers
- Krankenhaus Waldfriede e.V. — Berlin
- Agaplesion Markus Krankenhaus — Frankfurt am Main
- Studiengesellschaft BSF — Halle
- Universitaetsklinikum Jena — Jena
- Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel — Kiel
- St. Marien- und St. Annastiftskrankenhaus — Ludwigshafen
- Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik — Mannheim
Italy · 6 centers
Center list to be confirmed — check the primary protocol.
Spain · 6 centers
Center list to be confirmed — check the primary protocol.
Taiwan · 6 centers
Center list to be confirmed — check the primary protocol.
Austria · 5 centers
- Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universita — Vienna
- Medical University Innsbruck — Innsbruck
- Johannes Kepler Universitat Linz (JKU) — Linz
- Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss — Salzburg
- Krankenhaus der Barmherzigen Brueder Wien — Vienna
Belgium · 5 centers
- Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel — Brussels
- Imelda GI Clinical Research Center — Bonheiden
- Universitair Ziekenhuis Gent — Ghent
- University Hospitals Leuven — Leuven
- Centre Hospitalier Chretien MontLegia — Liège
Israel · 5 centers
- Soroka Medical Center — Beersheba
- Rambam Health Care Campus (RHCC) — Haifa
- … and 3 more centers
Poland · 5 centers
Center list to be confirmed — check the primary protocol.
Czechia · 4 centers
- Nemocnice Ceske Budejovice, a.s. — České Budějovice
- Fakultni Nemocnice Hradec Kralove — Hradec Králové
- Hepato-Gastroenterologie HK, s.r.o. — Hradec Králové
- IBD Clinical and Research centre — Prague
Netherlands · 4 centers
Center list to be confirmed — check the primary protocol.
Norway · 4 centers
Center list to be confirmed — check the primary protocol.
Sweden · 4 centers
Center list to be confirmed — check the primary protocol.
Switzerland · 4 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 4 centers
Center list to be confirmed — check the primary protocol.
Croatia · 3 centers
- Poliklinika Borzan d.o.o. — Osijek
- Clinical Hospital Center Rijeka — Rijeka
- University Hospital Centre Sestre Milosrdnice — Zagreb
Greece · 3 centers
- University of Athens School of Medicine, Alexandra General Hospital — Athens
- Metaxa Cancer Hospital — Piraeus
- University Hospital of Heraklion — Heraklion
Hungary · 3 centers
- Central Hospital of Northern Pest - Military Hospital — Budapest
- Semmelweis Egyetem — Budapest
- Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont — Szeged
Ireland · 3 centers
- Adelaide, Meath and National Children's Hospital — Dublin
- University College Dublin (UCD) - St. Vincent's University Hospital (SVUH) — Dublin
- Beaumont Hospital — Dublin
Portugal · 3 centers
Center list to be confirmed — check the primary protocol.
Denmark · 2 centers
- Aalborg Hospital — Aalborg
- Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling — Hvidovre
Slovenia · 1 center
Center list to be confirmed — check the primary protocol.
Publications
- Danese S, Sands BE, Feagan BG, Jairath V, Panaccione R, Peyrin-Biroulet L, Irving PM, Schreiber S, Dotan I, Ferrante M, D'Haens GR, Jones S, Freire M, Lindner D, Adsul S, Oberai P, Colombel JF. Design and rationale for the VICTRIVA study: A randomized, double-blind, phase 3b study of vedolizumab in combination with upadacitinib in Crohn's disease. Contemp Clin Trials Commun. 2025 Nov 24;48:101574. PMID 41403476
Identifiers
NCT: NCT06227910 · Vedolizumab-3043 · 2023-509391-42-00