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

Launched by SIXTH AFFILIATED HOSPITAL, SUN YAT-SEN UNIVERSITY · Mar 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called Upatinib to see how effective it is in treating active anal fistulas in patients with Crohn's disease. An anal fistula is a painful condition that can occur in people with Crohn's disease, which is a chronic inflammatory bowel condition. The trial aims to gather more evidence about how well Upatinib works for this issue, especially since most previous studies have focused on Western populations and not enough on patients in China.

To participate in this trial, you need to be between 18 and 70 years old and have a confirmed diagnosis of Crohn's disease with moderate to severe symptoms. You should also have an active anal fistula, confirmed by a doctor. However, some people may not qualify, such as those with a history of certain blood clots or severe infections. If you join the trial, you can expect to take Upatinib and be monitored by healthcare professionals to assess how well it works and if it's safe. This study is important because it could help improve treatment options for people in China dealing with this challenging condition.

Gender

ALL

Eligibility criteria

• 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.