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A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease

Sponsored by Takeda

About this trial

Last updated 18 days ago

Study ID

Vedolizumab-4051

Status

Recruiting

Type

Interventional

Phase

Phase 4

Placebo

No

Accepting

18-75 Years
18 to 70 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 adalimumab or vedolizumab (VDZ) together with ustekinumab (UST) in adults with moderate to severe Crohn's Disease, and the effect of treatment with vedolizumab alone, after the dual targeted treatment. The study is conducted in two parts. In Part A, participants will receive the dual targeted treatment (vedolizumab together with either adalimumab or ustekinumab). In part B, participants will receive vedolizumab only. Part B will include participants who responded to the treatment in Part A. Each participant will be followed up for at least 26 weeks after the last dose of treatment.

What are the participation requirements?

Yes

Inclusion Criteria

Men and women aged 18 to 65 years can participate in the study.
Must have Crohn’s Disease for at least 3 months before the study.
Must not have been responding properly to earlier treatment with ustekinumab, risankizumab, infliximab (or biosimilar), adalimumab or certolizumab pegol.
No

Exclusion Criteria

Cannot have short bowel syndrome, ulcerative colitis, an abscess in the belly (abdominal abscess) or fistula in the anus (perianal fistula) with abscess.
Cannot have parts of their bowels removed (colon resection) within 6 months of study participation
Cannot have had a stomach (gastric) bypass surgery.
Cannot have any organ transplantation.

Additional entry criteria will be discussed with the study doctor.

Locations

Location

Status

Recruiting
Recruiting
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Recruiting
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Recruiting
Recruiting
Recruiting
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Recruiting
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Recruiting
Not yet recruiting
Not yet recruiting

For more information, view the full study details:

NCT06045754