Combining vedolizumab and upadacitinib for treating Crohn's Disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to evaluate the effectiveness and safety of dual targeted therapy (DTT) using vedolizumab and upadacitinib compared to vedolizumab alone in adults with moderately to severely active Crohn's Disease. Participants will be randomly assigned to receive either the combination therapy or vedolizumab with a placebo for 12 weeks. Those who respond positively will continue with vedolizumab monotherapy for an additional 40 weeks. The study will involve multiple clinic visits and aims to assess bowel inflammation and ulcer reduction.

Why it matters

Who can join: the full rules

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.

Where it's running

• Peak Gastroenterology Associates
  Colorado Springs, Colorado, United States Recruiting
• Southern Star Research Institute, LLC
  San Antonio, Texas, United States Recruiting
• Tyler Research Institute, LLC
  Tyler, Texas, United States Recruiting
• Barrie GI Associates
  Barrie, Ontario, Canada Recruiting
• Taunton Surgical Centre-Oshawa Clinic
  Oshawa, Ontario, Canada Recruiting
• Toronto Immune and Digestive Health Institute (TIDHI)
  Toronto, Ontario, Canada Recruiting

+88 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Upadacitinib with or without vedolizumab for induction in moderate-to-severe ulcerative colitis

  This study tests whether adding vedolizumab to upadacitinib helps adults with moderate-to-severe ulcerative colitis achieve better short-term (8-week) control than upadacitinib alone.

  Recruiting at 6 sites Sixth Affiliated Hospital, Sun Yat-sen University · Foshan, Guangdong and 5 other locations · NCT07442045

• Second-line treatment with upadacitinib or risankizumab for adults with Crohn's disease

  This project will test how well upadacitinib or risankizumab work as second-line treatments for adults with moderate-to-severe Crohn's disease who previously used a TNF inhibitor.

  Recruiting at 25 sites AbbVie · Castellana Grotte, Bari and 24 other locations · NCT07073079

• Evaluating Upadacitinib for Inflammatory Bowel Disease

  This study is testing how well the oral medication Upadacitinib works for people in China with Inflammatory Bowel Disease who haven't responded to other treatments.

  Recruiting at 6 sites Sixth Affiliated Hospital, Sun Yat-sen University · Guangzhou, Guangdong and 5 other locations · NCT06780683

• Treatment of Ulcerative Colitis and Crohn's Disease with Vedolizumab

  This study is testing if a new medication called Vedolizumab can help adults with Ulcerative Colitis or Crohn's Disease feel better and stay symptom-free over a year.

  Recruiting at 78 sites Phase 4 Takeda · Birmingham, Alabama and 100 other locations · NCT06581328

• Assessing Upadacitinib Treatment in Adults with Inflammatory Bowel Disease in Belgium

  This study is testing how well the medication upadacitinib works and how safe it is for adults with moderate to severe ulcerative colitis and Crohn's disease in Belgium over three years.

  Recruiting at 11 sites AbbVie · Bonheiden, Antwerpen and 10 other locations · NCT06581042

• Long-term vedolizumab treatment for children and teenagers with ulcerative colitis or Crohn's disease

  This extension tests whether continuing subcutaneous vedolizumab is safe and helps children and teenagers with moderate to severe ulcerative colitis or Crohn's disease stay well.

  Recruiting at 12 sites Phase 3 Takeda · Phoenix, Arizona and 46 other locations · NCT06405087

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.