RecruitingPhase 1NCT06902987

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

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


Sponsor

Sixth Affiliated Hospital, Sun Yat-sen University

Enrollment

27 participants

Start Date

Jan 17, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether upatinib (a JAK inhibitor, a type of targeted anti-inflammatory drug) can treat active anal fistulas in people with moderate-to-severe Crohn's disease who also have a history of blood clots. **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of Crohn's disease with moderate-to-severe activity (CDAI score above 220) - You have an active anal fistula confirmed by MRI with symptoms like pain or drainage - You have a prior history of blood clots (such as deep vein thrombosis, pulmonary embolism, or stroke) - You have given informed consent **You may NOT be eligible if...** - You have a serious active infection (especially tuberculosis) - You have severe liver or kidney impairment - You are pregnant or breastfeeding - You have active cancer or a recent history of certain cancers Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGUpadacitinib

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

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NCT06902987