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NCT06045754

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

An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Dual Targeted Therapy With Vedolizumab Intravenous (IV) and Adalimumab Subcutaneous (SC) or Vedolizumab IV and Ustekinumab IV/SC in Moderate to Severe Crohn's Disease (CD)
Takeda·Phase 4·ClinicalTrials.gov·drugNot yet recruiting
View on ClinicalTrials.gov →
Study focus
Disease/Condition
Crohn's Disease
Drug/Device/Intervention
Vedolizumab
Study type
Interventional
Intervention type
drug
Sponsor & location
Primary sponsor
Takeda
Location
Chicago, United States of America
Timeline & enrollment
Phase
Phase 4
Start date
Jan 16, 2024
End date
Jun 28, 2027
Enrollment
150 participants
Primary outcome

Part A: Percentage of Participants Achieving Clinical Remission Based on the Crohn's Disease Activity Index (CDAI) at Week 26,Part B: Percentage of Participants in Clinical Remission Based on the CDAI at Week 52

Summary

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.

ICD-10 classifications
Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06045754
Type
Non-Device Trial
About this record

Access comprehensive clinical trial information for NCT06045754 through Pure Global AI's free database. This Phase 4 trial is sponsored by Takeda and is currently Not yet recruiting. The study focuses on Crohn's Disease. Target enrollment is 150 participants.

This page provides complete trial specifications, intervention details, outcomes, and location information. Pure Global AI offers free access to ClinicalTrials.gov data, helping medical device and pharmaceutical companies navigate clinical research efficiently.