Combining Vedolizumab and Upadacitinib for Ulcerative Colitis Treatment

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the effectiveness and safety of combining Vedolizumab (VDZ) with Upadacitinib (UPA) in patients suffering from moderate to severe ulcerative colitis (UC). The study aims to leverage the rapid onset of UPA to induce remission quickly while utilizing the long-term safety profile of VDZ for maintenance therapy. Participants will receive both medications for an initial 8-week period, followed by maintenance therapy with VDZ alone. The goal is to maximize clinical benefits for UC patients by addressing the limitations of each medication when used independently.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Diagnosed UC for at least 3 months, including endoscopic evidence supporting UC and histopathological evidence supporting UC diagnosis
* Suffering from moderate to severe UC, defined as modified Mayo score ≥ 4 and endoscopic subscale (ESS) ≥ 2
* Indications for VDZ or UPA application

Exclusion Criteria:

* Patients who are unable to take oral UPA and receive regular intravenous VDZ infusion therapy
* Evidence of toxic megacolon was found during screening
* Previously underwent extensive colectomy, subtotal resection, or total colectomy, ileostomy, or colostomy due to UC
* Subjects who require surgery due to UC or plan to undergo elective surgery during the study period
* There is evidence indicating that the subjects suffer from severe, progressive, or uncontrolled kidney, liver, blood, endocrine, respiratory, mental, or neurological diseases
* Evidence of active hepatitis B or C infection during screening

Where it's running

• the Sixth Affiliated Hospital of Sun Yat-Sen University
  Guangzhou, Guangdong, China Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.