NCT06227910

A Study of Vedolizumab With and Without Upadacitinib in Adults With Crohn's Disease

Name: Clinical Trial NCT06227910
Creator: Takeda
Keywords: Crohn's Disease, Vedolizumab, Phase 3, drug, clinical trial

A Randomized, Double-Blind, Placebo-Controlled Phase 3b Study to Evaluate the Short- and Long-Term Efficacy and Safety of Dual Targeted Therapy With Intravenous Vedolizumab and Oral Upadacitinib Compared With Intravenous Vedolizumab Monotherapy for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease

Takeda·Phase 3·ClinicalTrials.gov·drugNot yet recruiting

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Study focus

Disease/Condition: Crohn's Disease
Drug/Device/Intervention: Vedolizumab
Study type: Interventional
Intervention type: drug

Sponsor & location

Primary sponsor: Takeda

Timeline & enrollment

Phase: Phase 3
Start date: Jul 22, 2024
End date: Aug 01, 2028
Enrollment: 396 participants

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

Crohn disease, unspecifiedOther Crohn diseaseCrohn disease of large intestineCrohn disease [regional enteritis]Crohn disease of small intestine

Data source

Registry: ClinicalTrials.gov
Trial ID: NCT06227910
Type: Non-Device Trial

About this record

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.

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.