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

Conditions

• Active Anal Fistula
• Crohn's Diseases
• Upadacitinib

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Upadacitinib — DRUG
  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

Study Details

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.

Key Dates

Start date

Jan 17, 2024

Status verified

Mar 2025

Primary completion

Dec 30, 2025

Completion

Dec 30, 2026

Study Design

Enrollment

27 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Other: The primary endpoint was the combined response rate at 12 weeks of treatment
  Combined response refers to clinical response plus imaging response. Clinical response was defined as 100% closure of the external orifice of the fistula and no fluid seepage from the patient's complaint or physician's acupressure. Imaging remission was defined as the absence of \> 2cm pyo-filling fistula on perianal MRI and the absence of edema and active inflammation. Clinical response for the primary endpoint was judged by two experienced senior physicians and, if inconsistent, by a third clinician. The imaging was judged by two senior doctors in the independent third party diagnostic team, and if the judgment was inconsistent, the third team physician made the judgment

Primary Outcome Measure

Clinical response at 12 weeks of treatment [ Time Frame: 12 weeks ]