Real-World Study on the Safety and Effectiveness of IL-23 Inhibitors for Inflammatory Bowel Disease in China
Observational · No treatment assigned · Sites not listed yet · Sixth Affiliated Hospital, Sun Yat-sen University
Official record & contacts on ClinicalTrials.gov ↗
In plain English
What this trial is testing
Condition(s) listed: Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.
Who can join
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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.
There are also 2 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.
What's involved
- About 178 participants are expected to take part.
- Start date: 2025-10-01 (planned).
- Main results expected around 2028-10-01 (estimate from the record).
- No study sites are listed yet. Check the official record for contact details.
Main thing being measured
- clinical remission rate (Week 52)
In the researchers’ words
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.
This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.
Questions to ask your doctor and the trial team
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Not yet recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis) |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Enrollment | 178 (estimated) |
| Start date | 2025-10-01 |
| Primary completion (est.) | 2028-10-01 |
| First posted | 2025-09-19 |
| Last updated | 2025-09-19 |
| 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 |
Interventions
- 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,…
Full eligibility criteria (from the record)
Inclusion Criteria: 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. Exclusion Criteria: 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.
Locations (0)
No sites listed yet. The official record has contact information.
For contacts at each site, use the official record.
Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.