Guselkumab vs Ustekinumab for stricturing Crohn's disease

Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study

This study will follow adults with moderate-to-severe Crohn's disease and confirmed intestinal strictures to see if treatment with guselkumab or ustekinumab better controls obstructive symptoms and disease activity.

Quick facts

• Study type: Observational
• Enrollment: 100 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University (other)
• Drugs / interventions: Guselkumab, Ustekinumab, chemotherapy
• Locations: 1 site (Hangzhou, Zhejiang)
• Trial ID: NCT07444060 on ClinicalTrials.gov

What this trial studies

This is an observational cohort of adults with moderate-to-severe Crohn's disease and radiographic or endoscopic evidence of luminal strictures who are being treated with either guselkumab or ustekinumab. Patients provide consent and receive routine biologic therapy chosen by their physician while investigators collect baseline medical history and follow the treatment course. At scheduled follow-up visits investigators obtain blood, stool, and tissue samples as available and perform endoscopy, imaging, laboratory testing, symptom self-assessments, and nutritional screening. The study compares clinical symptoms, imaging and endoscopic findings, laboratory markers, and specimen-based biomarkers between the two treatment groups over time.

Who should consider this trial

Good fit: Adults aged 18–80 with confirmed moderate-to-severe Crohn's disease and clear radiographic or endoscopic luminal strictures who are being treated with guselkumab or ustekinumab and have recent obstructive symptoms.

Not a fit: Patients without true disease-related strictures, with only mild Crohn's symptoms, or those not receiving guselkumab or ustekinumab are unlikely to benefit from this study's findings.

Why it matters

Potential benefit: If successful, the findings could help doctors choose the biologic more likely to relieve obstructive symptoms and reduce the need for surgery in patients with stricturing Crohn's disease.

How similar studies have performed: Ustekinumab has established efficacy for Crohn's disease in prior trials, while guselkumab data in Crohn's—particularly for stricturing disease—is limited and less well studied.

Eligibility criteria

Inclusion Criteria:

* Confirmed patients with moderate-to-severe Crohn's disease (CD), aged 18 to 80 years, receiving treatment with Guselkumab or Ustekinumab.
* Presence of obstructive symptoms consistent with chronic or subacute intestinal obstruction within the past 8 weeks, with confirmed postprandial abdominal pain attributable to strictures, with the exclusion of: ① mild to moderate pain (postprandial abdominal pain or abdominal pain exacerbated by diet, ameliorated with abdominal bowel sounds) without nausea, vomiting or abdominal colic; ② dietary restrictions unrelated to abdominal pain.
* Evidence of definite luminal strictures caused by the disease itself confirmed by radiographic imaging or endoscopic examination, i.e., meeting any of the following criteria:

  1. Enteric computed tomography (CT): Presence of intestinal strictures on enteric CT, with two of the three following findings at the stricture site compared with the adjacent proximal bowel: ① a \>50% reduction in luminal diameter; ② a \>25% increase in bowel wall thickness; ③ pre-stenotic dilation \>2.5 cm.
  2. Endoscopic examination: Intestinal strictures that are impassable to the endoscope.

Exclusion Criteria:

* Patients with severe disease requiring emergency surgery or endoscopic therapeutic intervention, or those judged by the attending clinician to need a switch of medication or elective surgery within 2 months, such as those with acute severe intestinal obstruction, perforation, intra-abdominal abscess, intra-abdominal adhesion, and other conditions leading to obstruction, hemorrhage, infection, etc.
* Intestinal obstruction, intra-abdominal abscess, isolated intestinal stricture and other lesions secondary to surgery.
* Patients who have received definitive therapeutic interventions for strictures within the past 6 months, such as endoscopic balloon dilation, stricture incision, intestinal stricture plasty, surgical/manual anal dilatation, etc.
* Severe patients who remain unable to take oral intake despite enteral nutrition (EN) administration for more than 2 months.
* Patients who have used Guselkumab (GUS), Ustekinumab (UST) or other IL-23 antagonists within the past 12 months; or those with contraindications to GUS/UST, or intolerance to the study medications due to other causes (e.g., allergy to IL-23 antagonists).
* Patients with contraindications to small intestinal computed tomography (CT), such as contrast media allergy.
* Patients with relative contraindications to biological agents, such as active tuberculosis with a positive chest X-ray for pulmonary tuberculosis or a strongly positive tuberculin skin test; a history of myocardial infarction, heart failure or demyelinating neurological diseases within the past 5 years.
* Patients currently suffering from solid tumors, with a past history of lymphoma or melanoma, or undergoing chemotherapy or radiotherapy.
* Patients complicated with intestinal dysplasia (e.g., diagnosed with short bowel syndrome), colostomy or colorectal neoplasms.
* Patients complicated with active massive gastrointestinal hemorrhage, severe hepatic and renal dysfunction, active bacterial or viral infection, shock, as well as intractable vomiting and severe malabsorption syndrome.
* Pregnant or lactating patients.
* Patients with severe hemodynamic and vital sign instability, or those with rapidly progressive or end-stage diseases.
* Patients with psychiatric disorders, or those with insufficient educational level to fully understand the study content or unable to cooperate with the completion of the study.

Where this trial is running

Hangzhou, Zhejiang

• Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (RECRUITING)

Study contacts

• Study coordinator: Yan Chen

Conditions: CD - Crohn's Disease, Stricture, Bowel, IBD - Inflammatory Bowel Disease, Stricturing Crohn's Disease, Guselkumab, Ustekinumab