Treatment of active anal fistulas in Crohn's disease with Upadacitinib

Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease: a Single-center, Single-arm Study

This study is testing if Upadacitinib can help people with Crohn's disease who have active anal fistulas feel better and heal faster.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 27 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Drugs / interventions: upatinib, Upadacitinib
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT06902987 on ClinicalTrials.gov

What this trial studies

This study evaluates the efficacy and safety of Upadacitinib, a small molecule drug, in treating active anal fistulas in patients with Crohn's disease. It focuses on a single-center, single-arm approach to include patients diagnosed with moderate to severe Crohn's disease who also have confirmed active anal fistulas. The study aims to address the high incidence of anal fistulas in Asian populations, which is often underrepresented in existing research. By utilizing Upadacitinib, the study seeks to provide a more effective oral treatment option compared to traditional biologics.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 to 70 with moderate to severe Crohn's disease and confirmed active anal fistulas.

Not a fit: Patients with a history of thrombosis or allergies to the active ingredient of Upadacitinib may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from active anal fistulas associated with Crohn's disease.

How similar studies have performed: While there is limited data on Upadacitinib specifically for anal fistulas, other studies on similar small molecule treatments have shown promising results in managing Crohn's disease.

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.

Where this trial is running

Guangzhou, Guangdong

• Sixth afflicated of Sun-yat sen university — Guangzhou, Guangdong, China (Recruiting)

Conditions Crohn' s Diseases; Active Anal Fistula; Upadacitinib