Actively Recruiting
A Study of Vedolizumab IV with Adalimumab or Vedolizumab with Ustekinumab in Adults With Moderate to Severe Crohns Disease
Led by Takeda · Updated on 2026-03-18
100
Participants Needed
54
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the effects of combining vedolizumab intravenous infusion with either adalimumab or ustekinumab in adults who have moderate to severe Crohns Disease and have not responded adequately to certain previous treatments. The study aims to assess the effectiveness and safety of this dual targeted therapy and then evaluate vedolizumab alone in participants who respond to the combination treatment. This is an open-label Phase 4 study conducted in multiple centers in the United States and Canada, enrolling about 100 participants aged 18 to 70 years. Participants in Part A receive dual targeted therapy one group is treated with vedolizumab IV 300 mg at Weeks 0, 2, 6, and every 8 weeks up to Week 22 combined with adalimumab injections starting at 160 mg and tapering doses until Week 26 another group receives vedolizumab IV on the same schedule combined with weight-based ustekinumab IV followed by subcutaneous doses every 8 weeks until Week 24. Those showing therapeutic benefit by Week 26 enter Part B, receiving vedolizumab IV 300 mg monotherapy every 8 weeks from Week 30 to Week 46. Participants will have regular assessments including endoscopic evaluations using the Simple Endoscopic Score for Crohns Disease SES-CD at Weeks 26 and 52 to measure response. Other outcomes include clinical remission based on the Crohns Disease Activity Index CDAI, patient-reported symptom scores, and safety monitoring throughout the study. After completing treatments, participants will be followed for an additional 20 weeks, resulting in an overall participation time of about 76 weeks.
CONDITIONS
Brief Title
A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 to 70 years
- Confirmed diagnosis of Crohn's Disease at least 3 months before screening, verified by endoscopy
- Moderately to severely active Crohn's Disease at screening (SES-CD ≥6 or ≥4 if isolated ileal disease)
- Prior inadequate response, loss of response, or intolerance to at least one interleukin antagonist or tumor necrosis factor antagonist at approved doses
- Participants with inadequate responses to more than two classes of advanced therapies or more than one agent in the same class are not eligible
- For Part B: Investigator's opinion that participant shows therapeutic benefit at Week 26
You will not qualify if you...
- Crohn's Disease Activity Index (CDAI) score greater than 450
- Current diagnosis of ulcerative colitis or indeterminate colitis
- Clinical evidence of an abdominal abscess
- Known fistula other than perianal fistula, or perianal fistula with abscess
- Ileostomy, colostomy, or severe symptomatic intestinal stenosis
- Previous extensive bowel resection with loss of two entire segments of the intestine
- Short bowel syndrome
- Planned surgical intervention for Crohn's Disease except seton placement without abscess
- History or presence of adenomatous colonic polyps not removed
- History or evidence of colonic mucosal dysplasia
- Intolerance or contraindication to ileocolonoscopy
- Identified congenital or acquired immunodeficiency
- Active or latent tuberculosis
- Positive hepatitis B or C virus test
- Previous treatment with approved or investigational anti-integrin antibodies for Crohn's Disease
- History or symptoms of progressive multifocal leukoencephalopathy (PML)
Research Team
T
Takeda Contact
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