Testing Vedolizumab against a placebo for Crohn's disease
Official title: A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
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
Interventions
Vedolizumab
Vedolizumab IV infusion.
Upadacitinib
Upadacitinib over-encapsulated tablets.
Placebo
Upadacitinib matched placebo capsules.
Canadian Sites (9)
Heritage Medical Research Clinic - University Of Calgary
Calgary, Alberta, Canada
University of Manitoba-Winnipeg Regional Health Authority-Health Sciences Centre
Winnipeg, Manitoba, Canada
Dalhousie University
Halifax, Nova Scotia, Canada
Barrie GI Associates
Barrie, Ontario, Canada
McMaster University - Farncombe Family Digestive Health Research Institute (FFDHRI)
Hamilton, Ontario, Canada
Taunton Surgical Centre-Oshawa Clinic
Oshawa, Ontario, Canada
Toronto Immune and Digestive Health Institute (TIDHI)
Toronto, Ontario, Canada
Toronto Digestive Disease Associates
Vaughan, Ontario, Canada
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Eligibility Criteria
See who this study is looking for12 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450.
- +The participant has a diagnosis of CD established at least 3 months before screeningScreeningThe checks done before joining, to see whether a study fits.Read more → by clinical and endoscopic evidence and corroborated by a histopathology report.
- +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 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 baselineBaselineYour starting measurements, taken before treatment begins.Read more → or oral/intramuscular anti-infectives within 14 days prior to baseline.
- −The participant has evidence of an active infection during the screening periodScreeningThe checks done before joining, to see whether a study fits.Read more →, 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 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.
- −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 enrolledEnrolmentThe number of participants a study plans to include, or has included.Read more → in the study.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
What is being given or done in this study: Vedolizumab, Upadacitinib, PlaceboPlaceboA dummy treatment with no active medicine, used for comparison.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
- armsInterventionsModule.interventions[].name
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
There are 3 groups in this study.
From the trial registry
Built from this field:
- armsInterventionsModule.armGroups[].type
Who the study is looking for
The study lists an age range of 18 years to 65 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 396 people.
The study is currently expected to finish around August 2028.
The main measurement is taken over: Week 12.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12 — measured over Week 12.
Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12 — measured over Week 12.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06227910 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About VedolizumabDrug
Vedolizumab IV infusion.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About UpadacitinibDrug
Upadacitinib over-encapsulated tablets.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Upadacitinib matched placebo capsules.
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 65 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 65 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Week 12.
The study as a whole is currently expected to finish around 2028-08-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 396 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 11 locations, including: Calgary, Alberta, Canada; Winnipeg, Manitoba, Canada; Halifax, Nova Scotia, Canada; Barrie, Ontario, Canada; Hamilton, Ontario, Canada; Oshawa, Ontario, Canada, and 5 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
Other Sites (6)
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
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
Worth passing on?
Save it to the Care Package and send it to them, or to their doctor, in one message. Whether they follow it up is theirs to decide.
Review the Care PackageThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.