A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)
ConditionUlcerative Colitis
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Vedolizumab
- Tofacitinib
Treatment groups
65 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov