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New treatment option for Crohn's Disease
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 infusion into 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 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.
- 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; 2 entire...
- 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; 2 entire missing segments of the following 5 segments: terminal ileum, right...
- 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's taking place
- La Jolla, California, United States
- Los Angeles, California, United States
- Colorado Springs, Colorado, United States
- Naples, Florida, United States
- Orlando, Florida, United States
- Tampa, Florida, United States
- Indianapolis, Indiana, United States
- Lexington, Kentucky, United States
- New York, New York, United States
- Greenville, South Carolina, United States
- Rapid City, South Dakota, United States
- San Antonio, Texas, United States
- Tyler, Texas, United States
- Seattle, Washington, United States
- Milwaukee, Wisconsin, United States
- Vienna, State of Vienna, Austria
- Innsbruck, Tyrol, Austria
- Linz, Austria
- Salzburg, Austria
- Vienna, Austria
+ 99 more site(s).
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 - 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?
Study sites include La Jolla, California, United States; Los Angeles, California, United States; Colorado Springs, Colorado, United States; Naples, Florida, United States; Orlando, Florida, United States; Tampa, Florida, United States and 113 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.