A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC) (NCT06095128) | Clinical Trial Compass
RecruitingPhase 4
A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
United States65 participantsStarted 2024-06-12
Plain-language 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 is to learn about treatment with Vedolizumab alone after the double treatment.
All participants will receive vedolizumab together with tofacitinib for 8 weeks and will be checked for response. Participants who show a response to the treatment after 8 weeks will be treated with vedolizumab alone for an additional 44 weeks.
Each participant will be followed up for at least 26 weeks after the last dose of vedolizumab.
Who can participate
Age range18 Years β 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
β. 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.
β. 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 β₯1 and a centrally assessed endoscopic subscore β₯2 at screening.
β. Has evidence of UC extending proximally to the rectum \[β₯15 centimeter (cm) of involved colon\].
β. 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.
β. 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.
β. Has demonstrated an inadequate response to, loss of response to, or intolerance to at least 1, but no more than 2 TNFΞ± antagonists. Participants without prior failure or intolerance to biologics are not eligible. Participants who discontinued TNFΞ± antagonist therapy for reasons other than failure or intolerance (eg, pregnancy) may be eligible after discussion with the medical monitor.
β
What they're measuring
1
Percentage of Participants Achieving Clinical Remission at Week 8 Based on Complete Mayo Score
. 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 criteria
β. Has any of the following UC-related complications:
β. Acute severe UC.
β. The participant has had extensive colonic resection, subtotal or total colectomy.
β. The participant has clinical evidence of abdominal abscess or toxic megacolon.
β. The participant has an ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine.
β. Short bowel syndrome.
β. 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.
β. Has uncontrolled primary sclerosing cholangitis.