Crohn's Disease (CD)UPA-AGENCT06922331
Upadacitinib for Refractory IBD in Asian Children and Elderly: Age-Stratified Analysis
An observational study of Crohn's Disease (CD) and Ulcerative Colitis (UC), run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 9 to 99 years
- Conditions the study is for
- Crohn's Disease (CD), Ulcerative Colitis (UC), Refractory Crohn's Disease
- What is being tested?
- Upadacitinib
- How many people
- 21 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2023to 1 Mar 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 9 to 99 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Asian pediatric patients (ages 9-17) with refractory Crohn's disease and elderly patients (60 years and older) with refractory ulcerative colitis.
Who may be able to join
- Diagnosis of IBD according to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2023)"; Failure of at least two prior biological therapies (anti-TNF/anti-integrin/IL-12/23 inhibitors); Complete baseline and follow-up data (at least 12 weeks))
Who cannot join
- Active infection, malignancy, severe cardiovascular disease, or hepatic/renal insufficiency; Pregnancy or breastfeeding; Use of other JAK inhibitors within 30 days prior to baseline)
Trial locations and contacts
1 site in 1 country.
China1 site
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 515000
About this study
Official title: Age-Stratified Efficacy of Upadacitinib in Refractory Inflammatory Bowel Disease Among Asian Populations: Pediatric Crohn's Disease Versus Elderly Ulcerative Colitis Cohort Analysis
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.
- Conditions
- Crohn's Disease (CD), Ulcerative Colitis (UC), Refractory Crohn's Disease, Refractory Ulcerative Colitis, Inflammatory Bowel Disease (IBD), Pediatric Crohn's Disease
- Being tested
- Upadacitinib
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
A selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric Crohn's Disease (CD) Group | Patients aged 9-17 years diagnosed with refractory Crohn's disease who received upadacitinib treatment. Receives: Drug: Upadacitinib | |
| Elderly Ulcerative Colitis (UC) Group | Patients aged 60 years or older diagnosed with refractory ulcerative colitis who received upadacitinib treatment. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission Rate at Week 12
he proportion of patients achieving clinical remission at 12 weeks, as defined by [Specify the definition of clinical remission, e.g., "a Mayo score ≤ 2 with no individual subscore > 1" for UC or "a PCDAI score < 10" for CD].
Measured: Week 12
Endoscopic Response Rate at Week 12
The proportion of patients achieving endoscopic response at 12 weeks, as defined by [Specify the definition of endoscopic response, e.g., "a decrease of ≥50% from baseline in the SES-CD score" for CD or "a decrease of ≥ 1 point from baseline in the UCEIS" for UC].
Measured: Week 12
Secondary outcomes (2)
Clinical Response Rate at Week 12
The proportion of patients achieving clinical response at 12 weeks, as defined by [Specify the definition of clinical response, e.g., "a decrease of ≥ 3 points from baseline in the Mayo score" for UC or "a decrease of ≥ 20 points from baseline in the PCDAI score" for CD].
Measured: Week 12
Change in CRP from Baseline to Week 12
The change in C-reactive protein (CRP) levels from baseline to 12 weeks after treatment initiation.
Measured: Baseline to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2025
- Study start1 Jan 2023
- Primary completion31 Dec 2024
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's Disease (CD)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jiayin Yao, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06922331
- Sponsor's protocol ID
- 2025ZSLYEC-149
- Acronym
- UPA-AGE
- Status last verified
- Apr 2025
- First submitted
- 3 Apr 2025
- Last updated
- 10 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Age-Stratified Efficacy of Upadacitinib in Refractory Inflammatory Bowel Disease Among Asian Populations: Pediatric Crohn's Disease Versus Elderly Ulcerative Colitis Cohort Analysis
- ClinicalTrials.gov ID
- NCT06922331
- Acronym / sponsor ID
- UPA-AGE / 2025ZSLYEC-149
- Conditions
- Crohn's Disease (CD), Ulcerative Colitis (UC), Refractory Crohn's Disease, Refractory Ulcerative Colitis, Inflammatory Bowel Disease (IBD), Pediatric Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2024 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 10 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pediatric Crohn's Disease (CD) Group | – | Drug: UpadacitinibPatients aged 9-17 years diagnosed with refractory Crohn's disease who received upadacitinib treatment. |
| Elderly Ulcerative Colitis (UC) Group | – | Drug: UpadacitinibPatients aged 60 years or older diagnosed with refractory ulcerative colitis who received upadacitinib treatment. |
Who may qualify
- Ages
- 9 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Asian pediatric patients (ages 9-17) with refractory Crohn's disease and elderly patients (60 years and older) with refractory ulcerative colitis.
Key inclusion criteria (1 listed)
- Diagnosis of IBD according to the "Consensus on Diagnosis and Treatment of Inflammatory Bowel Disease (2023)"; Failure of at least two prior biological therapies (anti-TNF/anti-integrin/IL-12/23 inhibitors); Complete baseline and follow-up data (at least 12 weeks))
Key exclusion criteria (1 listed)
- Active infection, malignancy, severe cardiovascular disease, or hepatic/renal insufficiency; Pregnancy or breastfeeding; Use of other JAK inhibitors within 30 days prior to baseline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibA selective Janus kinase (JAK) 1 inhibitor used for the treatment of refractory inflammatory bowel disease. | Drug | Elderly Ulcerative Colitis (UC) Group, Pediatric Crohn's Disease (CD) Group |
Primary outcome
Clinical Remission Rate at Week 12
Time frame: Week 12
he proportion of patients achieving clinical remission at 12 weeks, as defined by [Specify the definition of clinical remission, e.g., "a Mayo score ≤ 2 with no individual subscore > 1" for UC or "a PCDAI score < 10" for CD].
Endoscopic Response Rate at Week 12
Time frame: Week 12
The proportion of patients achieving endoscopic response at 12 weeks, as defined by [Specify the definition of endoscopic response, e.g., "a decrease of ≥50% from baseline in the SES-CD score" for CD or "a decrease of ≥ 1 point from baseline in the UCEIS" for UC].
2 secondary outcomes
Clinical Response Rate at Week 12
Time frame: Week 12
Change in CRP from Baseline to Week 12
Time frame: Baseline to Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease (CD) and Ulcerative Colitis (UC), run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission Rate at Week 12 (time frame: Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2025.