Tests vedolizumab with or without upadacitinib for Crohn's disease
Tests two drugs together against one drug in adults with Crohn's disease.
Plain-language title generated from the registry record
Registry title: A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
Key facts
- Where
- Barrie, Calgary, Halifax, Hamilton, Montreal, Oshawa, Toronto, Vaughan, and Winnipeg, CanadaSee the 9 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT06227910, who can take part
Where in Canada
- Barrie GI AssociatesBarrie, CanadaTaking people
- Heritage Medical Research Clinic - University Of CalgaryCalgary, CanadaNo longer taking part
- Dalhousie UniversityHalifax, CanadaNot yet recruiting
- McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)Hamilton, CanadaNo longer taking part
- Centre Hospitalier de l'Université de MontréalMontreal, CanadaNot yet recruiting
- Taunton Surgical Centre-Oshawa ClinicOshawa, CanadaTaking people
- Toronto Immune and Digestive Health Institute (TIDHI)Toronto, CanadaTaking people
- Toronto Digestive Disease AssociatesVaughan, CanadaNot yet recruiting
- University of Manitoba-Winnipeg Regional Health Authority-Health Sciences CentreWinnipeg, CanadaNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Takeda
- Trial code
- NCT06227910EU 2023-509391-42-00
- Record updated
- 27 May 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: 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: 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 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 a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex; 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; The participant has a current diagnosis of ulcerative colitis or indeterminate colitis; The participant has an ostomy or ileoanal pouch.