Actively Recruiting
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Led by Sixth Affiliated Hospital, Sun Yat-sen University · Updated on 2025-03-30
27
Participants Needed
1
Research Sites
154 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older and 70 years or younger
- Confirmed diagnosis of Crohn's disease according to the 2018 Beijing consensus
- Moderate to severe disease activity with a CDAI score greater than 220
- Active anal fistula confirmed by perianal MRI with symptoms judged related to fistula activity
- History of thrombosis including deep vein thrombosis, pulmonary embolism, atrial, peripheral artery, or cerebral thrombosis confirmed by imaging
- Provided informed consent and agreed to participate voluntarily
You will not qualify if you...
- Allergy to upatinib active ingredient
- Severe liver or kidney damage; hemoglobin less than 8 g/L
- History of malignant tumors
- No history of thrombosis
- Neutrophil count less than 1 x 10^9/L or lymphocyte count less than 500 x 10^9/L
- Intestinal complications including strictures with proximal dilation or intestinal fistula as diagnosed by imaging
- Presence of enterostomy
- Active severe infection or opportunistic infection such as active tuberculosis or shingles
- Pregnant or planning pregnancy
- Presence of vaginal fistula
- Anorectal stenosis
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Sixth afflicated of Sun-yat sen university
Guangzhou, Guangdong, China, 510000
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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