NCT06902987RecruitingPhase 1
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease: a Single-center, Single-arm Study
Source: ClinicalTrials.gov · Last updated 30 Mar 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1
- Study type
- Interventional
- Enrollment
- 27 (estimated)
- First submitted
- 2 Jan 2025
- Start date
- 17 Jan 2024
- Primary completion date
- 30 Dec 2025
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Diseases
- Crohn's disease
- NCT number
- NCT06902987
What you commit to
- Study type: Interventional · Phase 1
- Planned participants: 27
- From 17 Jan 2024 to the primary completion date, 30 Dec 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients with previous thrombosis;
Other illness
- History of allergy to the active ingredient of upatinib;
- History of malignant tumor;
- Patients with intestinal complications (including intestinal stricture with proximal intestinal dilation or intestinal fistula). Diagnosis based on CTE/MRE.
- With active severe infection (such as sepsis) or opportunistic infection (such as active tuberculosis, shingles);
- Patients with vaginal fistula;
Lab values
- Severe damage of liver and kidney function; Hemoglobin \< 8g/L;
- Neutrophil count \< 1×109/L; , or lymphocyte count \< 500×109/L;
Other
- Presence of enterostomy;
- Pregnant or planning pregnancy.
- Patients with anorectal stenosis.
Who the study is looking for
- 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.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth afflicated of Sun-yat sen university Coordinator of this site? Confirm its status | Guangzhou | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.