What is this study trying to find out about Crohn's disease?

This study is evaluating how well Guselkumab and Ustekinumab work for patients with stricturing Crohn's disease, focusing on relief of intestinal narrowing and symptoms. Researchers aim to understand the treatments' effects on disease activity and blockage symptoms over time. The study is led by the Second Affiliated Hospital, School of Medicine, Zhejiang University.

Who may be eligible for this Crohn's disease clinical trial?

Adults aged 18 to 80 years with moderate-to-severe Crohn's disease who have intestinal strictures and related symptoms may be eligible. Both males and females can participate. Key factors include recent obstructive symptoms and no recent surgery or certain treatments for strictures. Please review eligibility criteria for more details.

Is there any cost to participate in this Crohn's disease clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and related expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any costs related to travel or accommodations.

Actively Recruiting

Age: 18Years - 80Years

All Genders

ID07444060

Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohns Disease A Multicenter, Prospective, Observational Cohort Study

Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2026-03-02

100

Participants Needed

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effects of Guselkumab and Ustekinumab in patients with moderate-to-severe Crohns disease CD who experience obstructive symptoms due to intestinal strictures. The study focuses on patients confirmed to have lumen narrowing caused by the disease, as verified by imaging or endoscopy. The goal is to assess disease activity, symptom relief, and remission through radiographic or endoscopic evidence over time. Participants are treated with either Guselkumab or Ustekinumab following detailed dosing schedules. Guselkumab treatment begins with intravenous doses every 4 weeks for 12 weeks, then switches to subcutaneous injections every 8 weeks, with possible adjustments based on disease activity. Ustekinumab starts with a single intravenous dose, followed by subcutaneous injections every 8 weeks, with options for dose optimization if needed. Nutritional support through enteral nutrition may also be adjusted during treatment. Both drugs are given according to physician judgment and patient needs. During the study, patients undergo regular follow-ups where blood, fecal, and tissue samples are collected. Assessments include gastrointestinal endoscopy, imaging, laboratory tests, symptom self-assessments, and nutritional risk screenings. Researchers monitor improvement in bowel strictures, general health, and track any surgeries up to 52 weeks. The primary outcome is continuation of Ustekinumab treatment at one year, with secondary measures including imaging improvements and health status evaluations.

CONDITIONS

Brief Title

Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease

Who Can Participate

Age: 18Years - 80Years

All Genders

Eligibility Criteria

You may qualify if you...

Adults aged 18 to 80 years
Confirmed moderate-to-severe Crohn's disease
Receiving treatment with Guselkumab or Ustekinumab
Obstructive symptoms consistent with chronic or subacute intestinal obstruction within the past 8 weeks
Postprandial abdominal pain caused by strictures, excluding mild to moderate pain without nausea, vomiting, or colic
Definite luminal strictures confirmed by radiographic imaging or endoscopy, meeting specific criteria for bowel narrowing or impassable strictures

You will not qualify if you...

Severe disease requiring emergency surgery or endoscopic intervention
Conditions like acute severe intestinal obstruction, perforation, intra-abdominal abscess, adhesion, or other causes leading to obstruction, bleeding, or infection
Lesions secondary to surgery such as isolated intestinal obstruction or abscess
Therapeutic interventions for strictures within the past 6 months
Inability to take oral intake despite enteral nutrition for more than 2 months
Use of Guselkumab, Ustekinumab, or IL-23 antagonists within the past 12 months or intolerance to these drugs
Contraindications to small intestinal CT or biological agents
Active tuberculosis or history of serious heart or neurological diseases within 5 years
Current solid tumors, past lymphoma or melanoma, or ongoing cancer treatments
Intestinal dysplasia, colostomy, or colorectal tumors
Active major gastrointestinal bleeding, severe liver or kidney dysfunction, infections, shock, severe vomiting, or malabsorption
Pregnant or lactating individuals
Severe hemodynamic instability or rapidly progressive or end-stage diseases
Psychiatric disorders or inability to understand study content or cooperate

Research Team

Yan Chen

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