New study pits two biologics against tough Crohn's complication
NCT ID NCT07444060
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at two drugs, guselkumab and ustekinumab, in 100 adults with moderate-to-severe Crohn's disease that has caused narrowing (strictures) in the bowel. The goal is to see which drug better controls symptoms and improves imaging results over 52 weeks. Participants continue their usual care, and the study tracks how well the drugs work without the need for additional treatments or surgery.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 100 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
Patients who will initially receive Guselkumab or Ustekinumab for the treatment of stricturing Crohn's disease
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Second Affiliated Hospital, School of Medicine, Zhejiang University
RECRUITINGHangzhou, Zhejiang, 310000, China
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