Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Recruiting now · Phase 1
Conditions studied: Crohn's Diseases, Active Anal Fistula, Upadacitinib
In brief
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 facts
- Study ID
- NCT06902987
- Run by
- Sixth Affiliated Hospital, Sun Yat-sen University
- People needed
- 27
- Starts
- 2024-01-17
- Expected to finish
- 2026-12-30
- Last updated by the study team
- 2025-03-30
Who can join
Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sixth afflicated of Sun-yat sen university — Guangzhou, Guangdong, China (enrolling)
Full record on ClinicalTrials.gov
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