Recruiting

Guselkumab and JAK Inhibitors for Difficult-to-Treat Inflammatory Bowel Disease

Study Aim

This observational study aims to evaluate the 12-week clinical response and 52-week endoscopic response in individuals with difficult-to-treat inflammatory bowel disease who are being treated with Guselkumab and JAK inhibitors.

What is being collected

Data Collection

Collected from today forward - Prospective

Who is being recruted

From 14 to 80 Years

+7 Eligibility Criteria

See all eligibility criteria

How is the trial designed

Cohort

Tracking disease incidence in order to identify risk factors and understand disease progression over time.

Observational

Study Start: January 2026

See protocol details

Summary

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Study ContactShurong Hu, PhD

Last updated: March 24, 2026

Sourced from a government-validated database.Claim as a partner

Study start date: January 7, 2026

Actual date on which the first participant was enrolled.

Inflammatory bowel disease (IBD) is a condition that can be hard to manage, especially when patients don't respond well to usual treatments like biologics and small molecule drugs. This can significantly affect their quality of life and long-term health outlook. To address this challenge, a new study is exploring the effectiveness and safety of a combination therapy. This therapy involves the use of a drug called guselkumab (GUS) along with JAK inhibitors, such as upadacitinib or tofacitinib, for patients with difficult-to-treat IBD. The goal is to find new treatment strategies that could improve care for these patients. This observational study will monitor participants over a certain period. The main focus is to evaluate the clinical response after 12 weeks and the endoscopic response after 52 weeks of treatment. An endoscopic response refers to the improvement seen in the lining of the gut using a special camera. This study will help understand the potential benefits and risks of this combination therapy for IBD patients who have not responded well to other treatments.

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

NCT07487311

Principal SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

Study ContactShurong Hu, PhD

Last updated: March 24, 2026

Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.

Design Details

80 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Cohort

These studies follow a group of individuals with common characteristics (such as a condition or birth year) over a specific period to study health outcomes or exposures.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.

Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 14 to 80 Years

Range of ages for which participants are eligible to join.

Criteria

4 inclusion criteria required to participate

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

3 exclusion criteria prevent from participating

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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Recruiting

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

Hangzhou, ChinaOpen Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine in Google Maps

Recruiting

One Study Center