Guselkumab plus a JAK inhibitor for difficult-to-treat inflammatory bowel disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center prospective observational cohort enrolling patients aged 14–80 with moderate-to-severe refractory IBD who have failed multiple biologics or meet surgical/perianal criteria. Participants treated with guselkumab combined with a JAK inhibitor (for example upadacitinib or tofacitinib) will be followed for safety and clinical outcomes, including CDAI, SES-CD, and modified Mayo scores. The study will track prior treatment history, surgical status, adverse events, and clinical response and remission rates over scheduled follow-up visits. Results are intended to provide real-world evidence on the tolerability and potential effectiveness of combining an IL-23 blocker with JAK inhibition in a hard-to-treat population.

Why it matters

Who can join: the full rules

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.

Where it's running

• Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
  Hangzhou, Zhejiang, China Recruiting

Study contacts

• Study coordinator: Shurong Hu, PhD
• Email: hushurong@zju.edu.cn
• Phone: 008619857407061

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.