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NCT Number: NCT07487311

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)

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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Key information

Conditions

Inflamatory Bowel Disease

Age range

14 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Drug

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

Primary outcomes

  1. 12-week clinical response and 52-week endoscopic response

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

Study contacts

Contact information is provided by the study sponsor or research team.

Shurong Hu, PhD

CONTACT

[email protected]

008619857407061

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2028
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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