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NCT06902987
Efficacy and Safety of Upatinib in the Treatment of Active Anal Fistulas in Crohn's Disease
Phase 1 trial testing Upadacitinib in Crohn's Diseases in 27 participants. Currently enrolling.
30 December 2025
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Phase | Phase 1 |
| Status | Recruiting now |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 27 |
| Start date | 17 January 2024 |
| Primary completion | 30 December 2025 |
| Estimated completion | 30 December 2026 |
| Sites | 1 location across China |
Drugs / interventions tested
- Upadacitinib — full drug profile →
Conditions studied
- Crohn's Diseases — all drugs for Crohn's Diseases →
- Active Anal Fistula — all drugs for Active Anal Fistula →
- Upadacitinib — all drugs for Upadacitinib →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 18 to 70, any sex, with Crohn's Diseases or Active Anal Fistula. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own 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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT06902987
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Other Sixth Affiliated Hospital, Sun Yat-sen University trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06902987 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sixth Affiliated Hospital, Sun Yat-sen University
- Last refreshed: 30 March 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06902987.
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