A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease - Trial NCT06227910
Access comprehensive clinical trial information for NCT06227910 through Pure Global AI's free database. This Phase 3 trial is sponsored by Takeda and is currently Not yet recruiting. The study focuses on Crohn's Disease. Target enrollment is 396 participants.
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Study Focus
Sponsor & Location
Takeda
Timeline & Enrollment
Phase 3
Jul 22, 2024
Aug 01, 2028
Primary Outcome
Percentage of Participants Achieving Clinical Remission Based on the CDAI at Week 12,Percentage of Participants Exhibiting an Endoscopic Response Based on Simple Endoscopic Score for CD (SES-CD) at Week 12
Summary
The main aim of this study is to learn whether vedolizumab and upadacitinib given together
 (also called dual targeted therapy or DTT) reduces bowel inflammation and ulcers in the bowel
 compared to vedolizumab only (also called monotherapy) in adults with moderately or severely
 active Crohn's Disease (CD) after 12 weeks of treatment. Other aims are to learn how safe and
 effective DTT is compared to monotherapy for these participants.
 
 All participants will receive DTT (either vedolizumab and upadacitinib or vedolizumab and
 placebo) for 12 weeks. Participants responding to the treatment will then receive vedolizumab
 only (monotherapy) for an additional 40 weeks.
 
 During the study, participants will visit their study clinic 15 times.
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06227910
Non-Device Trial