Tyler Research Institute | Tyler, TX
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About
The main aim of this study is to learn about the effect of treatment with vedolizumab IV (vedolizumab) together with adalimumab or vedolizumab together with ustekinumab 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.
Full description
The drug being tested in this study is vedolizumab. Vedolizumab is being tested to treat people with moderate to severe Crohn's disease who have experienced inadequate response, loss of response or intolerance to either one prior interleukin [IL] antagonist (Cohort 1) or one prior tumor necrosis factor inhibitor [TNFi] (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy.
The study will enroll approximately 150 patients. Participants will be assigned to one of the two treatment groups in Part A:
All participants who achieve clinical remission in Part A will receive vedolizumab IV 300 mg monotherapy from Week 30 until Week 46 in Part B. Participants will be followed for a further 20-week safety follow-up period to Week 72 (or 26 weeks post-last dose of study drug).
This multi-center trial will be conducted in the United States and Canada. The overall time to participate in this study is approximately 76 weeks.
Enrollment
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Inclusion criteria
Part A:
Has a confirmed diagnosis of CD at least 3 months before baseline, based on endoscopy results.
Has moderately to severely active CD at Screening, defined as a CDAI score ≥220 and a SES-CD ≥6 (≥4 if isolated ileal disease).
Has demonstrated at least 1 of the following (a, b, or c) to at least 1 IL antagonist or at least 1 tumor necrosis factor (TNF) antagonist, at doses approved for the treatment of CD:
Note: Participants with primary nonresponse to ≥2 agents are not eligible. Participants with intolerance to 2 agents may be eligible at the investigator's discretion.
Part B:
Participant is in clinical remission at Week 26. Note: Participants exhibiting a clinical response (defined as a ≥ 100-point decrease in CDAI) at Week 26 may enter Part B at the investigator's discretion.
Exclusion criteria
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150 participants in 3 patient groups
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Takeda Contact
Data sourced from clinicaltrials.gov
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