A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
VICTRIVA
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
2 other identifiers
interventional
396
26 countries
138
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jan 2025
Typical duration for phase_3
138 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 19, 2024
CompletedFirst Posted
Study publicly available on registry
January 29, 2024
CompletedStudy Start
First participant enrolled
January 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 8, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
August 1, 2028
June 3, 2025
May 1, 2025
2.4 years
January 19, 2024
May 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12
Clinical remission is defined as a CDAI score of \<150 points. CDAI assesses CD based on clinical signs such as number of liquid or very soft stools, abdominal pain, general wellbeing, extra-intestinal manifestations of CD, antidiarrheal use, presence of abdominal mass, hematocrit, and body weight. CDAI consists of eight factors, each summed after adjustment with a weighting factor. Total score ranges from 0 to 600 points. Higher scores indicate more severity.
Week 12
Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12
Endoscopic response per SES-CD is assessed as proportion of participants achieving decrease in SES CD \>50% from baseline (for participants with isolated ileal disease,SES-CD \<=4 or \<=2-point reduction from baseline) read centrally. SES-CD evaluates 4 endoscopic variables (ulcer size,percentage of ulcerated and affected surface area,presence and type of narrowings in 5 colonic segments evaluated during ileocolonoscopy (ileum,right,transverse,and left colon,rectum). Each variable is coded from 0 to 3 based on severity, where 0 is none or not severe and 3 is most severe case, with sum of the scores for each variable ranging from 0 to 15, except for presence of narrowing. Presence of narrowing ranges from 0 to 11 since a severity of 3 represents a narrowing which a colonoscope cannot be passed and, thus, can only be observed once among the bowel segments. Overall SES-CD score ranges from 0 to 56 and is sum of 4 variables across 5 bowel segments. Higher scores indicate more severe disease.
Week 12
Secondary Outcomes (10)
Percentage of Participants Achieving 2-item Patient-reported Outcome Measure (PRO2) Based Clinical Remission at Week 12
Week 12
Percentage of Participants Achieving Endoscopic Remission Based on SES-CD at Week 12
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
Week 12
Percentage of Participants Exhibiting a Clinical Response Based on the CDAI at Week 12
Week 12
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 52
Week 52
- +5 more secondary outcomes
Study Arms (3)
Double-blind Induction Phase: Vedolizumab + Upadacitinib
EXPERIMENTALParticipants will receive vedolizumab 300 mg intravenous (IV) infusion at Weeks 0, 2, 6 and 10 along with upadacitinib 45 mg, orally, once daily (QD) for 12 weeks.
Double-blind Induction Phase: Vedolizumab + Placebo
PLACEBO COMPARATORParticipants will receive vedolizumab IV 300 mg infusion, at Weeks 0, 2, 6 and 10 along with upadacitinib matched placebo, orally, QD for 12 weeks.
Main Study Maintenance Phase: Vedolizumab Monotherapy
EXPERIMENTALParticipants who achieve a CDAI reduction of \>=70 points from baseline at Week 12 will receive vedolizumab 300 mg IV infusion (monotherapy), every 8 weeks (Q8W) starting at Week 14 to 52. The Q8W vedolizumab monotherapy may be escalated to Q4W at the investigator's discretion.
Interventions
Vedolizumab IV infusion.
Upadacitinib over-encapsulated tablets.
Upadacitinib matched placebo capsules.
Eligibility Criteria
You may qualify if:
- 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 (excluding the presence of narrowing component) 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Study Sites (138)
UCSD Medical Center
La Jolla, California, 92037, United States
Keck Medicine Of USC - USC Healthcare Center 1
Los Angeles, California, 90033, United States
Peak Gastroenterology Associates
Colorado Springs, Colorado, 80907, United States
GI PROS, Inc.
Naples, Florida, 34102, United States
Orlando Health Ambulatory Care Center
Orlando, Florida, 32806, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, Florida, 33612, United States
Indiana University (IU) Health University Hospital
Indianapolis, Indiana, 46202, United States
University of Kentucky
Lexington, Kentucky, 40536, United States
Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center
New York, New York, 10029-5204, United States
Columbia University Medical Center, New York-Presbyterian Hospital
New York, New York, 10032, United States
Lenox Hill Hospital Northwell Health
New York, New York, 10075, United States
Gastroenterology Associates
Greenville, South Carolina, 29607, United States
Rapid City Medical Center
Rapid City, South Dakota, 57701, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Swedish Cancer Institute
Seattle, Washington, 98104, United States
University of Washington Medical Center - Montlake
Seattle, Washington, 98195, United States
Medical College of Wisconsin Cancer Center - Froedtert Hospital
Milwaukee, Wisconsin, 53226, United States
Medical University Innsbruck
Innsbruck, Tyrol, 6020, Austria
Medizinische Universitaet Wien - Allgemeines Krankenhaus der Stadt Wien (AKH) - Universitaetsklinik fuer Innere Medizin III
Vienna, Vienna, 1090, Austria
Johannes Kepler Universitat Linz (JKU)
Linz, 4021, Austria
Landeskrankenhaus Salzburg, Innere Medizin I, Labor im Erdgeschoss
Salzburg, 5020, Austria
Krankenhaus der Barmherzigen Brueder Wien
Vienna, 1020, Austria
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Brussel
Brussels, Anderlecht, 1070, Belgium
Imelda GI Clinical Research Center
Bonheiden, 2820, Belgium
Universitair Ziekenhuis Gent
Ghent, 9000, Belgium
University Hospitals Leuven
Leuven, 3000, Belgium
Centre Hospitalier Chretien MontLegia
Liège, 4000, Belgium
Hospital Universitario Cajuru
Curitiba, Paraná, 80050-350, Brazil
Faculdade de Medicina de Botucatu
Botucatu, São Paulo, 18618-970, Brazil
Centro de Estudos Clinico do Interior Paulista - CECIP
Jaú, São Paulo, 17201130, Brazil
Pesquisare Saude
Santo André, São Paulo, 9080110, Brazil
Universidade Federal do Rio de Janeiro (UFRJ)-Hospital Universitario Clementino Fraga Filho (HUCFF)
Rio de Janeiro, 21941-617, Brazil
Hospital das Clinicas of the University of Sao Paulo (Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo (HC/FMUSP))
São Paulo, 05403-010, Brazil
Unidade de Pesquisa Clinica UPC Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
São Paulo, 1405-1243, Brazil
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, T2N 4Z6, Canada
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
Winnipeg, Manitoba, R3A 1R9, Canada
Dalhousie University
Halifax, Nova Scotia, B3H 2Y9, Canada
Barrie GI Associates
Barrie, Ontario, L4M 7G1, Canada
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
Hamilton, Ontario, L8S 4K1, Canada
Taunton Surgical Centre-Oshawa Clinic
Oshawa, Ontario, L1J 0C7, Canada
Toronto Immune and Digestive Health Institute (TIDHI)
Toronto, Ontario, M6A 3B4, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, L4L 4Y7, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, H2X 0A9, Canada
Poliklinika Borzan d.o.o.
Osijek, 31000, Croatia
Clinical Hospital Center Rijeka
Rijeka, 51000, Croatia
University Hospital Centre Sestre Milosrdnice
Zagreb, 10000, Croatia
Nemocnice Ceske Budejovice, a.s.
České Budějovice, 370 01, Czechia
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
IBD Clinical and Research centre
Prague, 190 00, Czechia
Aalborg Hospital
Aalborg, 9000, Denmark
Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling
Hvidovre, 2650, Denmark
CHU d'Amiens-Picardie - Hopital SUD
Amiens, 80054, France
Hopital Huriez - CHRU de Lille
Lille, 59037, France
Chu - Hopital Nord
Marseille, 13015, France
Centre Hospitalier Universitaire de Nantes (CHU de Nantes) - Hopital Hotel Dieu
Nantes, 44093, France
Centre Hospitalier Universitaire de Bordeaux - Hopital Haut-Leveque
Pessac, 33600, France
CHU St Etienne Hopital Nord
Saint-Etienne, 42270, France
Centre Hospitalier Universitaire (CHU) de Toulouse - Hopital Rangueil
Toulouse, 31059, France
Centre Hospitalier Regional Universitaire de Nancy, Hopital Brabois
Vandœuvre-lès-Nancy, 54511, France
Krankenhaus Waldfriede e.V.
Berlin, 14163, Germany
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431, Germany
Studiengesellschaft BSF
Halle, 06108, Germany
Universitaetsklinikum Jena
Jena, 07747, Germany
Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel
Kiel, 24105, Germany
St. Marien- und St. Annastiftskrankenhaus
Ludwigshafen, 67065, Germany
Universitaetsklinikum Mannheim (Umm) - Ii Medizinische Klinik
Mannheim, 68167, Germany
University of Athens School of Medicine, Alexandra General Hospital
Athens, Attica, 11528, Greece
Metaxa Cancer Hospital
Piraeus, Attica, 185 37, Greece
University Hospital of Heraklion
Heraklion, Crete, 71110, Greece
Central Hospital of Northern Pest - Military Hospital
Budapest, 1062, Hungary
Semmelweis Egyetem
Budapest, 1082, Hungary
Szegedi Tudomanyegyetem Altalanos Orvostudomanyi Kar Szent-Gyorgyi Albert Klinikai Kozpont, I.Sz. Belogyaszati Klinika
Szeged, 6720, Hungary
Adelaide, Meath and National Children's Hospital
Dublin, 24, Ireland
University College Dublin (UCD) - St. Vincent's University Hospital (SVUH)
Dublin, D04 T6F4, Ireland
Beaumont Hospital
Dublin, D09 V2N0, Ireland
Soroka Medical Center
Beersheba, 8410101, Israel
Rambam Health Care Campus (RHCC)
Haifa, 3109601, Israel
Meir Medical Center
Kfar Saba, 44281, Israel
Rabin Medical Center - Beilinson Campus (Beilinson and Hasharon Hospital)
Petah Tikva, 49100, Israel
The Tel Aviv Sourasky Medical Center
Tel Aviv, 6423906, Israel
Ospedale San Raffaele (HSR) Instituto Scientifico Universitario San Raffaele
Milan, 20132, Italy
Azienda Ospedaliero Universitaria Federico II di Napoli
Naples, 80131, Italy
A. Gemelli University Hospital, Catholic University of the Sacred Heart
Roma, 00168, Italy
Humanitas Clinical And Research Institute
Rozzano, 20089, Italy
Fondazione IRCSS Casa Sollievo Della Sofferenza
San Giovanni Rotondo, 71013, Italy
AO Ordine Mauriziano di Torino
Torino, 10122, Italy
Amsterdam UMC Research BV
Amsterdam, 1105 AZ, Netherlands
Radboud University Medical Center
Nijmegen, 6525 GA, Netherlands
Erasmus Medisch Centrum
Rotterdam, 3015 GD, Netherlands
Elisabeth TweeSteden Ziekenhuis (ETZ)
Tilburg, 5022 GC, Netherlands
Vestre Viken HF - Baerum Sykehus
Drammen, Gjettum, 1309, Norway
Haukeland Universitetssjukehus (Haukeland University Hospital)
Bergen, N5021, Norway
Akershus University Hospital
Lorenskog, 1478, Norway
Oslo Universitetssykehus HF, Ulleval
Oslo, 0424, Norway
Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi
Lodz, 90-153, Poland
Samodzielny Publiczny Szpital Kliniczny Im. H. Swiecickiego Um
Poznan, 60-354, Poland
H-T. Centrum Medyczne Sp. z o.o. Sp.k.
Tychy, 43-100, Poland
Panstwowy Instytut Medyczny MSWiA
Warsaw, 02-507, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 05-401, Poland
Unidade Local de Saude Coimbra
Coimbra, 3000-075, Portugal
Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz
Lisbon, 1349-019, Portugal
Centro Hospitalar Universitario Lisboa Norte EPE
Lisbon, 1649-028, Portugal
University Clinical Centre - Ljubljana
Ljubljana, 1000, Slovenia
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Yeungnam University Medical Center
Daegu, 42415, South Korea
The Catholic University of Korea, Daejeon St.Mary's Hospital
Daejeon, 34943, South Korea
Kyung Hee University Hospital
Seoul, 02447, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591, South Korea
Chung-Ang University Hospital
Seoul, 06973, South Korea
The Catholic University Of Korea, St. Vincent's Hospital
Suwon, 16247, South Korea
Hospital General Universitario Gregorio Maranon (HGUGM)
Madrid, 28007, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitari Son Espases
Palma, 07120, Spain
Complejo Hospitalario de Navarra (CHN)
Pamplona, 31008, Spain
Complejo Hospitalario Universitario De Santiago De Compostela
Santiago de Compostela, 15706, Spain
Hospital Universitari I Politecnic La Fe
Valencia, 46026, Spain
Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken)
Linköping, Sweden
Ersta sjukhus
Stockholm, 116 30, Sweden
Karolinska Universitetssjukhuset - Hjartkliniken i Solna - Karolinska University Hospital
Stockholm, 171 76, Sweden
Danderyds Sjukhus AB
Stockholm, 182 88, Sweden
University Hospital Basel
Basel, 4031, Switzerland
University Hospital Bern (Inselspital)
Bern, 3010, Switzerland
Zentrum fur Gastroenterologie
Zurich, 8048, Switzerland
Universitatsspital Zurich
Zurich, 8091, Switzerland
Changhua Christian Hospital
Changhua, 50006, Taiwan
Chung Shan Medical University Hospital
Taichung, 40201, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
National Defense Medical Center (NDMC) (Tri-Service General Hospital (TSGH)) - Neihu
Taipei, 11490, Taiwan
Chang Gung Memorial Foundation Linkou Chang Gung Memorial Hospital
Taoyuan, 33305, Taiwan
St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
London, England, SE1 7EH, United Kingdom
The Royal London Hospital - Barts Health NHS Trust
London, Greater London, E1 1BB, United Kingdom
Western General Hospital
Edinburgh, Lothian, EH4 2XU, United Kingdom
Queen Elizabeth University Hospital - NHS Greater Glasgow & Clyde - South Glasgow University Hospital Division
Glasgow, Scotland, G51 4TF, United Kingdom
Related Publications (1)
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. doi: 10.1016/j.conctc.2025.101574. eCollection 2025 Dec.
PMID: 41403476DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 19, 2024
First Posted
January 29, 2024
Study Start
January 2, 2025
Primary Completion (Estimated)
June 8, 2027
Study Completion (Estimated)
August 1, 2028
Last Updated
June 3, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.