A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)

NCT07487311 — Recruiting, 80 participants, Second Affiliated Hospital, Zhejiang University, School of Medicine

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Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD

Registry	NCT07487311
Status	Recruiting
Study type	Observational
Enrollment	80 (Estimated)
Sponsor	Second Affiliated Hospital, Zhejiang University, School of Medicine (Other)
Conditions	Inflamatory Bowel Disease
Interventions	guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib) (Drug)
Dates	start 2026-01-07, primary completion 2027-12-31 (estimated), completion 2028-12-31 (estimated), first posted 2026-03-23, last updated 2026-03-23
Locations	1 site in China

-Summary

Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.

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+Arms and interventions

guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib) (Drug): guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)

+Outcome measures

Primary outcomes

12-week clinical response and 52-week endoscopic response [The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).]

+Eligibility

Sex: All, ages: 14 Years to 80 Years

Inclusion Criteria:

* Age 14-80 years with confirmed diagnosis of IBD;
* Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2);

  * Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2);
  * Signed informed consent.

Exclusion Criteria:

* Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation;

  * History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia;
  * Prior intolerance to JAK inhibitors or IL-23 inhibitors.

+Locations (1)

Facility	City	Country	Status
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine	Hangzhou, Zhejiang	China	Recruiting