Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Phase 1 · Testing Upadacitinib · 1 site · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
This study is testing Upadacitinib (a drug) as a possible treatment. Condition(s) listed: Crohn's Diseases, Active Anal Fistula and Upadacitinib.
It is open-label: participants know what they are receiving.
Phase 1 studies are early tests in a small group of people, mainly checking safety and dosing.
Who can join
- Ages 18 to 70
- Any sex
Some of the main requirements, copied from the record:
- 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.
Plus 3 more requirement(s). There are also 11 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 27 participants are expected to take part.
- Start date: 2024-01-17.
- Main results expected around 2025-12-30 (estimate from the record).
- 1 study site listed (1 marked recruiting) in China.
Main thing being measured
- Clinical response at 12 weeks of treatment (12 weeks)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Phase 1 |
| Study type | Interventional |
| Conditions | Crohn's Diseases; Active Anal Fistula; Upadacitinib |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 27 (estimated) |
| Start date | 2024-01-17 |
| Primary completion (est.) | 2025-12-30 |
| First posted | 2025-03-30 |
| Last updated | 2025-03-30 |
| Official title | Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease: a Single-center, Single-arm Study |
| ClinicalTrials.gov ID | NCT06902987 |
Interventions
- Upadacitinib (Drug)
Enrolled patients received oral upatinib treatment with a conventional induction dose of 45mg/d for 12 weeks, followed by a maintenance dose of 15m/d or 30mg/d
Full eligibility criteria (from the record)
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.
Locations (1)
| Site | City | Country | Site status |
|---|---|---|---|
| Sixth afflicated of Sun-yat sen university | Guangzhou, Guangdong | China | Recruiting |
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.