Tests upadacitinib for active anal fistulas in Crohn's disease
Tests an oral medicine, upadacitinib, in adults with active Crohn's disease anal fistulas.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Key facts
- Where
- Guangzhou, ChinaSee the site
- Phase
- Phase 1
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT06902987, who can take part
Where in China
- Sixth afflicated of Sun-yat sen universityGuangzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Sixth Affiliated Hospital, Sun Yat-sen University
- Trial code
- NCT06902987
- Record updated
- 30 March 2025
- Original description
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.Read full original descriptionShow less
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease: a Single-center, Single-arm Study
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.
Inclusion: 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: Patients with previous thrombosis; 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; Severe damage of liver and kidney function; Hemoglobin < 8g/L; Neutrophil count < 1×109/L; , or lymphocyte count < 500×109/L; Presence of enterostomy; Pregnant or planning pregnancy; Patients with anorectal stenosis.