A Study of Vedolizumab Intravenous (IV) and Adalimumab or Vedolizumab and Ustekinumab in Adults With Crohn's Disease
ConditionCrohn's Disease
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTakeda
About this trial
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.
Eligibility criteria
Qualifiers
Has a confirmed diagnosis of CD at least 3 months before screening, based on endoscopy results.
Has moderately to severely active CD at Screening, defined as an SES-CD >=6 (>=4 if isolated ileal disease).
Inadequate response after completing the full induction regimen;
Loss of response (recurrence of symptoms during scheduled maintenance dosing after prior clinical benefit); or
Disqualifiers
CDAI score > 450.
A current diagnosis of ulcerative colitis or indeterminate colitis.
Clinical evidence of an abdominal abscess.
Known fistula (other than perianal fistula) or phlegmon.
Trial design
Treatments tested in this trial
- Vedolizumab
- Adalimumab
- Ustekinumab
- Ustekinumab
Treatment groups
100 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov