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โ† Trials
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A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

RecruitingPhase 3Ages 18 Years - 65 YearsAllTakeda
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. 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. 2. The participant has a confirmed diagnosis of moderately to severely active CD as assessed by CDAI of 220-450. 3. 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. 4. The participant has demonstrated an inadequate response to, loss of response to, or intolerance to corticosteroids, immunomodulators, or biologic therapy. Exclusion Criteria: 1. The participant has a current diagnosis of ulcerative colitis or indeterminate colitis. 2. 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. 3. 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. 4. The participant has a history of recurrent or disseminated (including a single episode) herpes zoster, or disseminated (including a single episode) herpes simplex. 5. 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. 6. The participant has an ostomy or ileoanal pouch. 7. 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). 8. The participant has severe (Child-Pugh C) hepatic impairment.
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What it tests

  • Vedolizumab
  • Upadacitinib
  • Placebo
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Where

138 sites
UCSD Medical Center
La Jolla, United States
Keck Medicine Of USC - USC Healthcare Center 1
Los Angeles, United States
Peak Gastroenterology Associates
Colorado Springs, United States
GI PROS, Inc.
Naples, United States
Orlando Health Ambulatory Care Center
Orlando, United States
USF Health Morsani Center for Advanced Healthcare
Tampa, United States
Indiana University (IU) Health University Hospital
Indianapolis, United States
University of Kentucky
Lexington, United States

โ€ฆand 130 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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