Vedolizumab with Adalimumab or Ustekinumab Studied for Crohn's Endoscopic Response
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Key Takeaway
Consider dual therapy with vedolizumab for Crohn's patients unresponsive to prior treatments.
This Phase 4 study evaluates the efficacy and safety of vedolizumab in combination with either adalimumab or ustekinumab in adults with moderate to severe Crohn's Disease. The study is structured in two parts: Part A involves dual targeted therapy, while Part B involves vedolizumab monotherapy for those who respond in Part A. The primary endpoint is the percentage of participants achieving an endoscopic response, as measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD), at Week 26 for Part A and at Week 52 for Part B. Participants are categorized into cohorts based on prior treatment responses, including those with inadequate response to IL antagonists, TNF inhibitors, or Janus kinase inhibitors. The study aims to enroll 100 participants, with an estimated primary completion date in June 2027. Safety and adverse events will be monitored throughout the study, although specific safety data are not yet available. This trial could provide insights into the efficacy of dual targeted therapy in this patient population.
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View Original Abstract ↓
Status: RECRUITING | Phase: PHASE4
Condition(s): Crohn's Disease
Intervention(s): Vedolizumab (DRUG), Adalimumab (DRUG), Ustekinumab (DRUG), Ustekinumab (DRUG)
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.
Detailed: 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, and no other biologic/small molecule (Group A); one IL antagonist and either one Janus kinase inhibitor (JAKi) or one TNFi (other than adalimumab) \[Group B\] (Cohort 1) or one prior tumor necrosis factor inhibitor \[TNFi\] and no other biologic/small molecule (Group C); one TNFi and either 1 JAKi or one IL antagonist (other than UST) (Group D) (Cohort 2). The study will look at the efficacy and safety of dual targeted therapy.
The study will enroll approximately 100 participants. Participants will be assigned to one of the two trea
Primary Outcome(s): Part A: Percentage of Participants With an Endoscopic Response Based on the Simple Endoscopic Score for (SES-CD) at Week 26; Part B: Percentage of Participants With an Endoscopic Response Based on the SES-CD at Week 52
Enrollment: 100 (ESTIMATED)
Lead Sponsor: Takeda
Start: 2024-04-18 | Primary Completion: 2027-06-28
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