A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Recruiting · NCT06227910 · Interventional (participants receive a specific treatment) · Lead sponsor: Takeda
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years to 65 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 11 US states.
- UCSD Medical Center - La Jolla, California, United States
- Keck Medicine Of USC - USC Healthcare Center 1 - Los Angeles, California, United States
- Peak Gastroenterology Associates - Colorado Springs, Colorado, United States
- GI PROS, Inc. - Naples, Florida, United States
- Orlando Health Ambulatory Care Center - Orlando, Florida, United States
- USF Health Morsani Center for Advanced Healthcare - Tampa, Florida, United States
- Indiana University (IU) Health University Hospital - Indianapolis, Indiana, United States
- University of Kentucky - Lexington, Kentucky, United States
- Mount Sinai Hospital - The Susan and Leonard Feinstein Inflammatory Bowel Disease (IBD) Clinical Center - New York, New York, United States
- Columbia University Medical Center, New York-Presbyterian Hospital - New York, New York, United States
- Lenox Hill Hospital Northwell Health - New York, New York, United States
- Gastroenterology Associates - Greenville, South Carolina, United States
- Rapid City Medical Center - Rapid City, South Dakota, United States
- Southern Star Research Institute, LLC - San Antonio, Texas, United States
- Tyler Research Institute, LLC - Tyler, Texas, United States
- Virginia Mason Medical Center - Seattle, Washington, United States
- Swedish Cancer Institute - Seattle, Washington, United States
- University of Washington Medical Center - Montlake - Seattle, Washington, United States
- Medical College of Wisconsin Cancer Center - Froedtert Hospital - Milwaukee, Wisconsin, United States
- Aalborg Hospital - Aalborg, Denmark
- CHU d'Amiens-Picardie - Hopital SUD - Amiens, France
- Amsterdam UMC Research BV - Amsterdam, Netherlands
- University Hospital Basel - Basel, Switzerland
- Soroka Medical Center - Beersheba, Israel
- Haukeland Universitetssjukehus (Haukeland University Hospital) - Bergen, Norway
- Krankenhaus Waldfriede e.V. - Berlin, Germany
- University Hospital Bern (Inselspital) - Bern, Switzerland
- Imelda GI Clinical Research Center - Bonheiden, Belgium
- Central Hospital of Northern Pest - Military Hospital - Budapest, Hungary
- Semmelweis Egyetem - Budapest, Hungary
- Inje University Haeundae Paik Hospital - Busan, South Korea
- Changhua Christian Hospital - Changhua, Taiwan
- Unidade Local de Saude Coimbra - Coimbra, Portugal
- Yeungnam University Medical Center - Daegu, South Korea
- The Catholic University of Korea, Daejeon St.Mary's Hospital - Daejeon, South Korea
- Adelaide, Meath and National Children's Hospital - Dublin, Ireland
- University College Dublin (UCD) - St. Vincent's University Hospital (SVUH) - Dublin, Ireland
- Beaumont Hospital - Dublin, Ireland
- Agaplesion Markus Krankenhaus - Frankfurt am Main, Germany
- Universitair Ziekenhuis Gent - Ghent, Belgium
- Rambam Health Care Campus (RHCC) - Haifa, Israel
- Studiengesellschaft BSF - Halle, Germany
- Fakultni Nemocnice Hradec Kralove - Hradec Králové, Czechia
- Hepato-Gastroenterologie HK, s.r.o. - Hradec Králové, Czechia
- Hvidovre Hospital Medicinsk Gastroenterologisk Afdeling - Hvidovre, Denmark
- Universitaetsklinikum Jena - Jena, Germany
- Meir Medical Center - Kfar Saba, Israel
- Universitaetsklinikum Schleswig-Holstein, UKSH-Campus Kiel - Kiel, Germany
- University Hospitals Leuven - Leuven, Belgium
- Hopital Huriez - CHRU de Lille - Lille, France
- Universitetssjukhuset i Linkoping, Endokrin- och magtarmmedicinska Kliniken (EM-Kliniken) - Linköping, Sweden
- Johannes Kepler Universitat Linz (JKU) - Linz, Austria
- Centro Hospitalar de Lisboa ocidental (CHLO), Hospital Egas Moniz - Lisbon, Portugal
- Centro Hospitalar Universitario Lisboa Norte EPE - Lisbon, Portugal
- Centre Hospitalier Chretien MontLegia - Liège, Belgium
- University Clinical Centre - Ljubljana - Ljubljana, Slovenia
- Oddzial Kliniczny Gastroenterologii Ogolnej i Onkologicznej SPZOZ Uniwersytecki Szpital Kliniczny Nr 1 im. Barlickiego Uniwersytetu Medycznego w Lodzi - Lodz, Poland
- Akershus University Hospital - Lorenskog, Norway
- St. Marien- und St. Annastiftskrankenhaus - Ludwigshafen, Germany
- Hospital General Universitario Gregorio Maranon (HGUGM) - Madrid, Spain
Showing 60 of 138 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →