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)
| NCT ID | NCT07487311 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Second Affiliated Hospital, Zhejiang University, School of Medicine |
| Condition | Inflamatory Bowel Disease |
| Study Type | OBSERVATIONAL |
| Enrollment | 80 participants |
| Start Date | 2026-01-07 |
| Primary Completion | 2027-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 80 participants in total. It began in 2026-01-07 with a primary completion date of 2027-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07487311 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, up to 80 Years, studying Inflamatory Bowel Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07487311 currently recruiting?
Yes, NCT07487311 is actively recruiting participants. Contact the research team at hushurong@zju.edu.cn for enrollment information.
Where is the NCT07487311 trial being conducted?
This trial is being conducted at Hangzhou, China.
Who is sponsoring the NCT07487311 clinical trial?
NCT07487311 is sponsored by Second Affiliated Hospital, Zhejiang University, School of Medicine. The trial plans to enroll 80 participants.