Status:
RECRUITING
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
Lead Sponsor:
Takeda
Conditions:
Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with tofacitinib in adults with moderate and severe ulcerative colitis (UC). Another aim...
Detailed Description
The drugs being tested in this study are called Vedolizumab and Tofacitinib. Vedolizumab and Tofacitinib dual targeted therapy is being tested to treat people with moderate to severe ulcerative coliti...
Eligibility Criteria
Inclusion
- Has a confirmed diagnosis of UC established at least 3 months prior to screening, by clinical and endoscopic evidence and corroborated by a histopathology report.
- Has moderately to severely active UC as determined by a complete Mayo score \[including physician's global assessment (PGA)\] of 6 to 12 with a rectal bleeding subscore ≥1 and a centrally assessed endoscopic subscore ≥2 at screening.
- Has evidence of UC extending proximally to the rectum \[≥15 centimeter (cm) of involved colon\].
- Participants with extensive colitis or pancolitis of \>8 years duration or left sided colitis \>12 years duration must have documented evidence that a surveillance colonoscopy was performed within 12 months of the initial screening visit.
- Participants with a family history of colorectal cancer, personal history of increased colorectal cancer risk, age \>50 years, or other known risk factors must be up to date on colorectal cancer surveillance.
- Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFα antagonists. Participants without prior failure or intolerance to biologics are not eligible. Participants who discontinued TNFα antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.
- Note: After the interim analysis, participants with inadequate response, loss of response, or intolerance to conventional UC therapy without prior exposure to biologics may be enrolled if deemed appropriate. Participants who discontinued biologics for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the Medical Monitor.
- If using corticosteroids must be on a stable dose of oral corticosteroids up to a maximum of 40 mg daily of prednisone or 9 mg daily of budesonide, or equivalent for at least 2 weeks prior to screening endoscopy and must be willing to follow a mandatory taper of corticosteroids from enrollment.
Exclusion
- Gastrointestinal Exclusion criteria:
- Has any of the following UC-related complications:
- Acute severe UC.
- The participant has had extensive colonic resection, subtotal or total colectomy.
- The participant has clinical evidence of abdominal abscess or toxic megacolon.
- The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
- Short bowel syndrome.
- Has Crohn's colitis, indeterminate colitis, ischemic colitis, nonsteroidal anti-inflammatory drug (NSAID) induced colitis, idiopathic colitis (i.e, colitis not consistent with UC), radiation colitis, microscopic colitis, colonic mucosal dysplasia, or untreated bile acid malabsorption. Participants with a history of colonic mucosal dysplasia are also excluded.
- Has uncontrolled primary sclerosing cholangitis.
- Infectious Disease
Key Trial Info
Start Date :
June 12 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 9 2027
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT06095128
Start Date
June 12 2024
End Date
July 9 2027
Last Update
December 29 2025
Active Locations (50)
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1
Digestive Health Specialsits
Dothan, Alabama, United States, 36301
2
GI Alliance Sun City
Sun City, Arizona, United States, 85351
3
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
4
Hoag Hospital Newport Beach
Newport Beach, California, United States, 92663