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

NCT06227910 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 396

Last updated 2025-06-03

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Vedolizumab

Vedolizumab IV infusion.

DRUG

Upadacitinib

Upadacitinib over-encapsulated tablets.

DRUG

Placebo

Upadacitinib matched placebo capsules.

Sponsors & Collaborators

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-02
Primary Completion
2027-06-08
Completion
2028-08-01
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Brazil
  • Canada
  • Croatia
  • Czechia
  • Denmark
  • France
  • Germany
  • Greece
  • Hungary
  • Ireland
  • Israel
  • Italy
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovenia
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06227910 on ClinicalTrials.gov