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RECRUITING
NCT06902987
PHASE1

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease

Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University

View on ClinicalTrials.gov

Summary

Anal fistula is the most common perianal lesion of Crohn's disease (CD), and the incidence of anal fistula in eastern CD population is significantly higher than that in Western population. The treatment of CD active anal fistula is difficult, which seriously affects the quality of life of patients and consumes a lot of medical resources. Injection of biological agents is the most commonly used method for the treatment of CD anal fistula, small molecule drugs can be taken orally, and the curative effect is more lasting. Upadacitinib was the first small molecule drug approved for CD treatment in China on June 30, 2023. At present, there is only one post-subgroup analysis of a global Phase 3 clinical study on Upatinib in the treatment of CD anal fistula, and the number of active anal fistula cases included is small, and the study objects are mostly western populations. This study intends to include CD patients with active anal fistula, and adopts the method of single-center single-arm study to explore the efficacy of Upatinib in the treatment of CD anal fistula, so as to provide more evidence-based medical evidence for the drug selection of CD anal fistula in China.

Official title: Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease: a Single-center, Single-arm Study

Key Details

Gender

All

Age Range

18 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

27

Start Date

2024-01-17

Completion Date

2026-12-30

Last Updated

2025-03-30

Healthy Volunteers

No

Interventions

DRUG

Upadacitinib

Enrolled patients received oral upatinib treatment with a conventional induction dose of 45mg/d for 12 weeks, followed by a maintenance dose of 15m/d or 30mg/d

Locations (1)

Sixth afflicated of Sun-yat sen university

Guangzhou, Guangdong, China