Combining Vedolizumab and Upadacitinib for Ulcerative Colitis Treatment
Efficacy and Safety Analysis of Sequential Treatment of Moderate to Severe Ulcerative Colitis With Vedolizumab and Upadacitinib: A Multicenter Prospective Randomized Controlled Clinical Study
This study is testing if combining two medications, Vedolizumab and Upadacitinib, can help people with moderate to severe ulcerative colitis feel better faster and stay well longer.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 334 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | Vedolizumab, Upadacitinib |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT06095596 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with moderate to severe ulcerative colitis for at least three months, who meet specific clinical criteria.
Not a fit: Patients who have undergone extensive surgical procedures related to ulcerative colitis or those with severe uncontrolled comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this combination therapy could provide a more effective treatment option for patients with moderate to severe ulcerative colitis, potentially leading to quicker remission and improved long-term management.
How similar studies have performed: While the combination of these specific therapies is novel, previous studies have shown success with individual therapies in managing ulcerative colitis.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Guangzhou, Guangdong
- the Sixth Affiliated Hospital of Sun Yat-Sen University — Guangzhou, Guangdong, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.