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NCT06922331: UPA-AGE
Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis
trial testing Upadacitinib in Crohn's Disease (CD) in 21 participants. Completed in 1 March 2025.
31 December 2024
Quick facts
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 21 |
| Start date | 1 January 2023 |
| Primary completion | 31 December 2024 |
| Estimated completion | 1 March 2025 |
| Sites | 1 location across China |
Drugs / interventions tested
- Upadacitinib — full drug profile →
Conditions studied
- Crohn's Disease (CD) — all drugs for Crohn's Disease (CD) →
- Ulcerative Colitis (UC) — all drugs for Ulcerative Colitis (UC) →
- Refractory Crohn's Disease — all drugs for Refractory Crohn's Disease →
- Refractory Ulcerative Colitis — all drugs for Refractory Ulcerative Colitis →
Sponsor
Sixth Affiliated Hospital, Sun Yat-sen University
Who can join
Adults 9 to 99, any sex, with Crohn's Disease (CD) or Ulcerative Colitis (UC). Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This single-center, retrospective study aims to evaluate the effectiveness and safety of upadacitinib (UPA) in Asian pediatric patients with refractory Crohn's disease (CD) and elderly patients with refractory ulcerative colitis (UC). The study will analyze data from 21 patients (11 children aged 9-17 with CD and 10 adults aged 60 and older with UC) treated at the Sixth Affiliated Hospital of Sun Yat-sen University between January 2023 and December 2024. The primary objective is to assess the clinical remission rate and endoscopic response rate in both groups. Secondary objectives include comparing treatment outcomes between the two age groups, exploring the impact of immunosenescence on UPA efficacy in elderly UC patients, and analyzing the correlation between laboratory markers (CRP, albumin) and clinical outcomes. This study is the first in Asia to investigate the age-stratified efficacy of upadacitinib in pediatric CD and elderly UC patients. The findings will provide crucial real-world evidence to inform individualized treatment strategies for these specific populations. Patients included in this study will have previously failed at least two biological therapies. Data collected will include demographics, disease characteristics, prior treatment history, UPA dosage and duration, clinical and endoscopic scores (PCDAI/Mayo, SES-CD/UCEIS), imaging results, laboratory values, and adverse events. The study is registered on ClinicalTrials.gov (NCT06274996). Ethical considerations will be addressed through data anonymization and a waiver of informed consent due to the retrospective nature of the study.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Age-Stratified Efficacy of Upadacitinib in Refractory Pediatric Crohn's Disease and Geriatric Ulcerative Colitis: An Asian Cohort Study.
Wu H, Lu Y, Su Y, Su T, et al · · 2025 · PMID 40860936 · DOI 10.2147/jir.s534439
Verify or expand the search:
- PubMed search for NCT06922331
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT07546097 — Comparative Effectiveness of Upadacitinib vs Corticosteroids as First-Line Therapy for Acute Severe Ulcerative Colitis（U · Phase 4 · recruiting
- NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
Other recruiting trials for Crohn's Disease (CD)
Currently open trials in the same condition.
- NCT06895772 — Microbial Community Characteristics in Intestinal Mucosal Tissue of Patients With CD · active not recruiting
Other Sixth Affiliated Hospital, Sun Yat-sen University trials
Trials by the same sponsor.
- NCT07538284 — MInimizing Delirium With Nasal Dexmedetomidine-InducEd Sleep (MIDDIES) · Phase 2, PHASE3 · not yet recruiting
- NCT07176182 — Clinical Trial of Neoadjuvant mFOLFOX Plus Alvenor for LARC Patients With High YWHAB Expression · Phase 2 · not yet recruiting
- NCT07510191 — TNFi Plus Low-Dose Upadacitinib vs TNFi Intensification in Crohn's Disease With Suboptimal Response · Phase 4 · recruiting
- NCT07344428 — Efficacy and Safety of CDED With Anti-TNF-α Biologics in Crohn's Disease: A Randomized Trial · NA · not yet recruiting
- NCT07328958 — Effect of Titrated Administration of Ciprofol on Perioperative Hypotension in Elderly Patients Undergoing Laparoscopic A · NA · recruiting
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 NCT06922331 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- 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: 10 April 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/NCT06922331.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing