Evaluating Upadacitinib for Inflammatory Bowel Disease
Official title: Efficacy and Safety of Upadacitinib in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study
Run by Sixth Affiliated Hospital, Sun Yat-sen University · NCT06780683 · Data updated 2026-11-12
This study is testing how well the oral medication Upadacitinib works for people in China with Inflammatory Bowel Disease who haven't responded to other treatments.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 174 (estimated) |
| Sponsor | Sixth Affiliated Hospital, Sun Yat-sen University Academic / other |
| Drugs / interventions | upadacitinib |
| Locations | 6 sites (Guangzhou, Guangdong and 5 other locations) |
| Status | Recruiting |
| Started | January 1, 2024 |
| Main results expected | December 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | January 17, 2025 |
| Trial ID | NCT06780683 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients of any gender diagnosed with ulcerative colitis or Crohn's disease who require initial treatment with Upadacitinib.
✕Probably not a fit
Patients currently participating in other clinical studies or those with contraindications to Upadacitinib will not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study focuses on the efficacy and safety of Upadacitinib in treating patients with Inflammatory Bowel Disease (IBD), specifically Crohn's Disease and Ulcerative Colitis, in China. It aims to gather real-world data from multiple centers to assess how well this oral medication works for patients who are either primary or secondary non-responders to existing biologic treatments. By analyzing the outcomes of patients requiring Upadacitinib, the study seeks to provide valuable insights for clinical decision-making in the management of IBD.
Why it matters
Potential benefit: If successful, this study could improve treatment options and outcomes for patients with Inflammatory Bowel Disease in China.
How similar studies have gone: While there is limited research on Upadacitinib specifically in the Chinese IBD population, other studies have shown positive outcomes with similar biologic treatments in IBD.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Inclusion criteria were patients of any gender, diagnosed with ulcerative colitis or Crohn's disease according to current guidelines, requiring initial upadacitinib treatment as judged by the treating physician, and providing signed informed consent. Exclusion Criteria: * Exclusion criteria included current or planned participation in any other clinical study, contraindications to upadacitinib treatment as per the drug's instructions, and patients deemed unsuitable for the study by the researchers.
Where it's running
-
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China Recruiting -
Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China Recruiting -
Meizhou People's Hospital
Meizhou, Guangdong, China Recruiting -
The Eighth Affiliated Hospital, Sun Yat-Sen University
Shenzhen, Guangdong, China Recruiting -
Liuzhou People's Hospital
Liuzhou, Guangxi, China Recruiting -
Ruikang Hospital Affiliated to Guangxi University of Chinese Medicine
Nanning, Guangxi, China Recruiting
Study contacts
- Study coordinator: Lang Lin
- Email: linlang3@mail.sysu.edu.cn
- Phone: +86-020-38663423
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Longitudinal Immunophenotyping of People with Inflammatory Bowel Disease
This study will follow adults with Crohn's disease or ulcerative colitis (and some healthy relatives) over three years to see how their immune cells change over time and how genetics and diet relate to their disease.
-
Assessing Upadacitinib Treatment in Adults with Inflammatory Bowel Disease in Belgium
This study is testing how well the medication upadacitinib works and how safe it is for adults with moderate to severe ulcerative colitis and Crohn's disease in Belgium over three years.
-
Advanced therapies for moderately to severely active Crohn's disease or ulcerative colitis in adults
This study tests combinations of risankizumab with either trosunilimab or ABBV-701 in adults with moderately to severely active Crohn's disease or ulcerative colitis.
-
Pregnancy in people with inflammatory bowel disease
This project will see if pregnancy changes how often women with IBD have disease flares by analyzing registry data from women who had pregnancies.
-
Real-world use of guselkumab for adults with moderate-to-severe ulcerative colitis and Crohn's disease in the UK
This project will see how well guselkumab works for adults with moderate-to-severe ulcerative colitis or Crohn's disease who are starting the treatment in routine UK care.
-
Guselkumab treatment for Crohn's disease and ulcerative colitis in Germany
This project will try to see how well guselkumab works and how it affects symptoms, quality of life, and daily activities for adults with Crohn's disease or ulcerative colitis receiving routine care in Germany.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.