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

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.

NCT Number	NCT06902987
Lead Sponsor	Sixth Affiliated Hospital, Sun Yat-sen University
Conditions	Crohn's Diseases, Active Anal Fistula, Upadacitinib
Enrollment	27 participants
Start Date	2024-01-17
Primary Completion	2025-12-30 (estimated)
Study Completion	2026-12-30 (estimated)
Updated on ClinicalTrials.gov	2025-03-30