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Ulcerative Colitis

A Study of Vedolizumab With Tofacitinib in Adults With Ulcerative Colitis (UC)

Sponsored by Takeda

About this trial

Last updated 4 days ago

Study ID

Vedolizumab-4054

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 65 Years
All
All

Not accepting

Not accepting
Healthy Volunteers

Trial Timing

Started a year ago

What is this trial about?

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.

What are the participation requirements?

Yes

Inclusion Criteria

Men and women aged 18 to 65 years can participate in the study.
Must have ulcerative colitis (UC) for at least 3 months before the study.
Must have moderate or severe UC
Must have proof of UC extending close to the anus.
No

Exclusion Criteria

Cannot have acute serious UC, parts of their bowel removed (colon resection), an abscess in the belly (abdominal abscess), or short bowel syndrome.
Cannot have Crohn's disease or a condition that affects bile duct.
Cannot have received an infusion of antibiotics within 8 weeks of treatment in the study and cannot have received any treatment of UC via the anus within 2 weeks of participation in the study.
Cannot have undergone surgery that required general anesthesia within 3 months of study participation.

Additional entry criteria will be discussed with the study doctor.

Locations

Location

Status

Recruiting
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Not yet recruiting
Not yet recruiting
Not yet recruiting

For more information, view the full study details:

NCT06095128