Crohn's Disease study: Vedolizumab vs Upadacitinib
Official title A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease
ClinicalTrials.gov ID: NCT06227910
What this study is testing
What is Vedolizumab?
Vedolizumab is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for crohn's disease.
Also referred to as Entyvio, MLN0002.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if adding upadacitinib to vedolizumab reduces bowel inflammation and ulcers more than vedolizumab alone, and to compare safety and effectiveness of the two approaches.
- Who it's for
- Adults who have moderate or severe Crohn's disease.
- What's involved
- Participants will receive either vedolizumab with upadacitinib or vedolizumab with a placebo for 12 weeks, then responders will continue with vedolizumab alone for up to 40 more weeks. The study includes clinic visits and tests.
- Time commitment
- The trial lasts up to 52 weeks with about 15 clinic visits over that time.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- The participant has a diagnosis of CD established at least 3 months before screening by clinical and endoscopic evidence and corroborated by a...
- 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...
- The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic...
You likely can't join 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...
- The participant has evidence of an active infection during the screening period, or clinically significant infection within 30 days prior to...
- The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode)...
- The participant has any of the following ongoing known complications of CD: abscess (abdominal or peri-anal); symptomatic bowel strictures
- The participant has an ostomy or ileoanal pouch.
See the full eligibility 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.
- 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
- 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 study team makes the final eligibility decision.
Where it is enrolling
- Colorado Springs, Colorado, United States
- San Antonio, Texas, United States
- Tyler, Texas, United States
- Barrie, Ontario, Canada
- Oshawa, Ontario, Canada
- Toronto, Ontario, Canada
- Busan, South Korea
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Colorado Springs, Colorado, United States; San Antonio, Texas, United States; Tyler, Texas, United States; Barrie, Ontario, Canada; Oshawa, Ontario, Canada; Toronto, Ontario, Canada and 2 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.