Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 |
Not provided
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.
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kang Chao, Professor | Contact | +86586084 | chaokang3@mail.sysu.edu.cn |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 | 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 | Week 52 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
Not provided
Not provided