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Clinical Trials in China / NCT06902987
Recruiting Phase 1

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

NCT06902987 · tracked via the Priya Life Science China tracker
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Phase
Phase 1
Started
2024-01-17
Last updated
2025-03-30

Condition(s) studied

Crohn's DiseasesActive Anal FistulaUpadacitinib

Investigational drug(s) / intervention(s)

Upadacitinib →

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

Study 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

Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria: * Age ≥18 years and ≤70 years; * Make a clear diagnosis of CD according to the "Consensus Opinions on the Diagnosis and Treatment of Inflammatory Bowel Disease (Beijing, 2018)"; * The disease severity of CD was moderate and severe according to Crohn's diseaseactivityindex (CDAI), that is, CDAI score \> 220. * Complicated with active anal fistula, that is, on the basis of perianal MRI confirmation of anal fistula, the patient has perianal pain, fluid seepage and other symptoms, and the transanal surgeon judges that the symptoms are related to anal fistula activity; * Patients with previous thrombosis, including deep vein thrombosis, pulmonary thromboembolism, atrial thrombosis, peripheral artery thrombosis and cerebral thrombosis confirmed by imaging; * Informed consent. The subjects gave barrier-free informed consent, voluntarily participated in the clinical study and signed the informed consent. Exclusion Criteria: * History of allergy to the active ingredient of upatinib; * Severe damage of liver and kidney function; Hemoglobin \< 8g/L; * History of malignant tumor; * Patients with previous thrombosis; * Neutrophil count \< 1×109/L; , or lymphocyte count \< 500×109/L; * Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on CTE/MRE. * Presence of enterostomy; * With active severe infection (such as sepsis) or opportunistic infection (such as active tuberculosis, shingles); * Pregnant or planning pregnancy. * Patients with vaginal fistula; * Patients with anorectal stenosis.

Primary outcome measure(s)

  • Clinical response at 12 weeks of treatment — 12 weeks
    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 at 12 weeks of treatment — 12 weeks
    Imaging remission was defined as the absence of \> 2 cm pyo-filling fistula on perianal MRI and the absence of edema and active inflammation

Trial sites (1)

FacilityCityRegionStatus
Sixth afflicated of Sun-yat sen university Guangzhou Guangdong Recruiting

On this site

📄 Rinvoq (upadacitinib) drug profile →

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06902987 on ClinicalTrials.gov ↗ ← All trials in China