Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)NCT07184138
Real-World Study on the Safety and Effectiveness of IL-23 Inhibitors for Inflammatory Bowel Disease in China
An observational study of Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Sixth Affiliated Hospital, Sun Yat-sen University.
Trial summary
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has shown greatly improved outcomes with biologic therapies. However, nearly half of patients still experience primary or secondary non-response to existing biologics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
- What is being tested?
- Interleukin-23 Inhibitors (IL-23i)
- How many people
- 178 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Nov 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients in China diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating treatment with an interleukin-23 inhibitor (IL-23i) for the first time in routine clinical practice.
Who may be able to join
- Adults aged 18 years or older, any gender. Formally diagnosed with ulcerative colitis (UC) or Crohn's disease (CD). Determined by the treating physician to require initiation of IL-23 inhibitor (IL-23i) therapy for the first time.
Who cannot join
- Currently enrolled in or planning to participate in any other interventional clinical study.
- Contraindications to IL-23i treatment as specified in the drug label. Considered by the investigator to be unsuitable for participation in the study for any reason.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Efficacy and Safety of Interleukin-23 Inhibitors (IL-23i) in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has shown greatly improved outcomes with biologic therapies. However, nearly half of patients still experience primary or secondary non-response to existing biologics. Interleukin-23 (IL-23), a member of the IL-12 cytokine family, plays a role in maintaining intestinal homeostasis but is also involved in the pathogenesis of IBD. IL-23 is a heterodimer composed of p19 and p40 subunits linked by a disulfide bond. Humanized monoclonal antibodies selectively targeting the IL-23 p19 subunit have emerged as promising therapies for IBD. Recently, selective IL-23p19 inhibitors-risankizumab (Risan) and mirikizumab-have been approved for the treatment of moderately to severely active CD and UC, respectively. In addition, these agents, along with guselkumab (Gus), are undergoing clinical trials for both CD and UC (guselkumab, gus, and mirikizumab for CD; guselkumab and risankizumab for UC). Guselkumab (Gus) and risankizumab (Risan), both targeting the IL-23 p19 subunit, have been approved in China for the treatment of CD, with guselkumab also approved for UC. However, data on the efficacy and safety of IL-23 inhibitors (IL-23i) in Chinese UC and CD patients remain limited, and evidence in Chinese IBD populations is lacking. This is a multicenter, single-arm, prospective, observational real-world study designed to evaluate the efficacy and safety of IL-23i in adult UC and CD patients in routine clinical practice in China.
- Being tested
- Interleukin-23 Inhibitors (IL-23i)
- Keywords
- IL23i, Crohn's disease, Ulcerative Colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interleukin-23 Inhibitors (IL-23i)Drug
Adult patients will receive treatment with an interleukin-23 inhibitor (IL-23i), including guselkumab or risankizumab, as prescribed in routine clinical practice in China. This observational study does not mandate dosing, administration schedule, or concomitant medications; treatments follow standard of care. Patients will be prospectively monitored for clinical effectiveness, endoscopic outcomes, and safety over 52 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Adult IBD Patients Treated With IL-23i | Adult patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) in China who are initiating treatment with an interleukin-23 inhibitor (IL-23i) in a real-world clinical practice setting. Patients will be observed prospectively for treatment effectiveness and safety outcomes. Receives: Drug: Interleukin-23 Inhibitors (IL-23i) |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical remission rate
To evaluate the effectiveness of IL-23 inhibitors (IL-23i) in real-world adult patients with ulcerative colitis (UC) or Crohn's disease (CD) by assessing clinical remission at Week 52
Measured: Week 52
Secondary outcomes (4)
clinical response rate
To assess the real-world effectiveness of IL-23i in adult UC or CD patients by evaluating clinical response at Week 52
Measured: week 52
endoscopic remission rate
To evaluate endoscopic remission at Week 52 in adult UC or CD patients receiving IL-23i in routine clinical practice
Measured: Week 52
endoscopic response rate
To evaluate endoscopic response at Week 52 in adult UC or CD patients receiving IL-23i in routine clinical practice
Measured: week 52
Incidence of adverse events (AEs) and serious adverse events (SAEs) through Week 52
To assess the safety of IL-23i in adult UC and CD patients by recording all adverse events (AEs) and serious adverse events (SAEs) occurring during the 52-week observation period
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2028 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)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
- Prospective
- Enrolment
- 178 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chao Kang, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07184138
- Sponsor's protocol ID
- 20250913
- Status last verified
- Sep 2025
- First submitted
- 13 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Interleukin-23 Inhibitors (IL-23i) in the Treatment of Inflammatory Bowel Disease in China: A Multicenter, Single-Arm, Prospective, Observational Real-World Study
- ClinicalTrials.gov ID
- NCT07184138
- Acronym / sponsor ID
- 20250913
- Keywords
- IL23i, Crohn's disease, Ulcerative Colitis
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 178 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2028 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 19 Sep 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.
Inflammatory bowel disease (IBD), including ulcerative colitis (UC) and Crohn's disease (CD), has shown greatly improved outcomes with biologic therapies. However, nearly half of patients still experience primary or secondary non-response to existing biologics. Interleukin-23 (IL-23), a member of the IL-12 cytokine family, plays a role in maintaining intestinal homeostasis but is also involved in the pathogenesis of IBD. IL-23 is a heterodimer composed of p19 and p40 subunits linked by a disulfide bond. Humanized monoclonal antibodies selectively targeting the IL-23 p19 subunit have emerged as promising therapies for IBD. Recently, selective IL-23p19 inhibitors-risankizumab (Risan) and mirikizumab-have been approved for the treatment of moderately to severely active CD and UC, respectively. In addition, these agents, along with guselkumab (Gus), are undergoing clinical trials for both CD and UC (guselkumab, gus, and mirikizumab for CD; guselkumab and risankizumab for UC). Guselkumab (Gus) and risankizumab (Risan), both targeting the IL-23 p19 subunit, have been approved in China for the treatment of CD, with guselkumab also approved for UC. However, data on the efficacy and safety of IL-23 inhibitors (IL-23i) in Chinese UC and CD patients remain limited, and evidence in Chinese IBD populations is lacking. This is a multicenter, single-arm, prospective, observational real-world study designed to evaluate the efficacy and safety of IL-23i in adult UC and CD patients in routine clinical practice in China.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult IBD Patients Treated With IL-23i | – | Drug: Interleukin-23 Inhibitors (IL-23i)Adult patients diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) in China who are initiating treatment with an interleukin-23 inhibitor (IL-23i) in a real-world clinical practice setting. Patients will be observed prospectively for treatment effectiveness and safety outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients in China diagnosed with ulcerative colitis (UC) or Crohn's disease (CD) who are initiating treatment with an interleukin-23 inhibitor (IL-23i) for the first time in routine clinical practice.
Key inclusion criteria (1 listed)
- Adults aged 18 years or older, any gender. Formally diagnosed with ulcerative colitis (UC) or Crohn's disease (CD). Determined by the treating physician to require initiation of IL-23 inhibitor (IL-23i) therapy for the first time.
Key exclusion criteria (2 listed)
- Currently enrolled in or planning to participate in any other interventional clinical study.
- Contraindications to IL-23i treatment as specified in the drug label. Considered by the investigator to be unsuitable for participation in the study for any reason.
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 |
|---|---|---|
| Interleukin-23 Inhibitors (IL-23i)Adult patients will receive treatment with an interleukin-23 inhibitor (IL-23i), including guselkumab or risankizumab, as prescribed in routine clinical practice in China. This observational study does not mandate dosing, administration schedule, or concomitant medications; treatments follow standard of care. Patients will be prospectively monitored for clinical effectiveness, endoscopic outcomes, and safety over 52 weeks. | Drug | Adult IBD Patients Treated With IL-23i |
Primary outcome
clinical remission rate
Time frame: Week 52
To evaluate the effectiveness of IL-23 inhibitors (IL-23i) in real-world adult patients with ulcerative colitis (UC) or Crohn's disease (CD) by assessing clinical remission at Week 52
4 secondary outcomes
clinical response rate
Time frame: week 52
endoscopic remission rate
Time frame: Week 52
endoscopic response rate
Time frame: week 52
Incidence of adverse events (AEs) and serious adverse events (SAEs) through Week 52
Time frame: Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 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.
Questions about this trial
What is this clinical trial studying?
An observational study of Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Sixth Affiliated Hospital, Sun Yat-sen University.
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 2 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: opening soon, as of the sponsor's last update on 19 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kang Chao, Professor (+86586084, chaokang3@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical remission rate (time frame: Week 52). 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 19 Sep 2025.