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

• 1 other identifier: 研2025-1622
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Inflamatory Bowel Disease

Outcome Measures

Primary Outcomes (1)

• 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%).

Interventions

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

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

Eligibility Criteria

• Age: 14 Years - 80 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Moderate to severe active Inflammatory bowel disease

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

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

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Interventions

guselkumab; Janus Kinase Inhibitors; upadacitinib; tofacitinib

Intervention Hierarchy (Ancestors)

Protein Kinase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses

Central Study Contacts

Shurong Hu, PhD

CONTACT

008619857407061; hushurong@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2026
• First Posted: March 23, 2026
• Study Start: January 7, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 23, 2026

Record last verified: 2026-01

Locations

CN (1)