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 to 70 Years
All
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?
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.
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
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Not yet recruiting
Not yet recruiting
For more information, view the full study details:
NCT06045754