CD - Crohn's DiseaseNCT07444060
Guselkumab Vs Ustekinumab in Stricturing Crohn's Disease
An observational study of CD - Crohn's Disease and Stricture; Bowel, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- CD - Crohn's Disease, Stricture; Bowel, IBD - Inflammatory Bowel Disease
- What is being tested?
- Guselkumab (GUS) and Ustekinumab (UST)
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Mar 2026to 31 Dec 2029
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who will initially receive Guselkumab or Ustekinumab for the treatment of stricturing Crohn's disease
Who may be able to join
- 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:
- 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.
- Endoscopic examination: Intestinal strictures that are impassable to the endoscope.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Second Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310000
Yan Chen, 86+13757118653, chenyan72_72@zju.edu.cn
About this study
Official title: Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with Guselkumab or Ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.
- Being tested
- Guselkumab (GUS), Ustekinumab (UST)
- Keywords
- Stricturing Crohn's Disease, Guselkumab, Ustekinumab
- Medical subject headings
- Crohn Disease, Constriction, Pathologic, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab (GUS)Drug
① Induction phase (Weeks 1-12): GUS 200 mg intravenously (IV) every 4 weeks for 3 doses, followed by a maintenance phase with GUS 100 mg subcutaneously (SC) every 8 weeks (for patients with all indicators within the normal range).
② Maintenance phase: Dosing adjustments shall be optimized based on the clinician's experience: If any disease activity occurs during the maintenance phase (e.g., suboptimal levels of CRP or FCP), administer GUS 200 mg SC every 4 weeks, or GUS 100 mg SC every 8 weeks plus enteral nutrition accounting for no more than 50% of the total daily energy intake. In case of persistent disease activity, administer intensive intravenous infusion of GUS 200 mg for 3 doses based on patient needs and shared decision-making.
Ustekinumab (UST)Drug
① Induction phase (Weeks 1-8): UST 6 mg/kg intravenously (IV) for 1 dose, followed by UST 90 mg subcutaneously (SC) every 8 weeks. A maintenance dose of 90 mg SC shall be administered every 8 or 12 weeks thereafter on a case-by-case basis.
② Experience-based dosing optimization and adjustment: If C-reactive protein (CRP) or fecal calprotectin (FCP) levels are suboptimal, two treatment approaches shall be adopted based on patient needs and shared decision-making: intravenous intensification therapy (predominantly 2 to 3 IV doses, i.e., 260 mg or 390 mg, with a follow-up visit at 8 weeks); or 90 mg SC with a shortened administration interval (with a follow-up visit at 4 to 6 weeks).
③ The duration of Exclusive Enteral Nutrition (EEN) use shall not exceed 2 weeks. If enteral nutrition support is required beyond 2 weeks, switch to Partial Enteral Nutrition (PEN), which shall account for less than 50% of the patient's total energy requirement.
| Study group | Role | What they receive |
|---|---|---|
| GUS | Guselkumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease Receives: Drug: Guselkumab (GUS) | |
| UST | Ustekinumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease Receives: Drug: Ustekinumab (UST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuation of ustekinumab
The primary endpoint was the success at week 52, defined as ustekinumab continuation with all the following criteria: (1) no use of a prohibited treatment (corticosteroids after the eight week following inclusion, parenteral nutrition, other anti-TNFs); (2) no endoscopic dilation; (3) no bowel surgery for resection of small bowel stricture; (4) no severe adverse events leading to ustekinumab withdrawal and (5) no study withdrawal whatever the reason.
Measured: up to 52 weeks
Secondary outcomes (3)
CT stricture improvement
CT stricture improvement was defined as resolution of prestenotic dilatation (small bowel diameter <3.0 cm); stricture resolution (normal bowel wall thickness and luminal diameter with absence of prestenotic dilation; and reduced stricture length by ≥1 mm). Intestinal ultrasound stricture improvement included normalisation of prestenotic dilation (<3.0 cm) or reduction in prestenotic dilation (≥50%).
Measured: at Week 0 and 52
General health improvement
General health improvement was measured by patient reported outcomes through health-related quality of life (Inflammatory Bowel Disease (IBD) Quality of Life Questionnaire).
Measured: at Week 0, 8, 24 and 52
Number of Participants with surgery
Surgical rates during follow-up included the proportion of patients undergoing any surgery for endoscopic dilatation and stricture resection.
Measured: up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2026
- Study start1 Mar 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CD - Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- People's Hospital of Chongqing
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07444060
- Sponsor's protocol ID
- 2025-1589
- Status last verified
- Jan 2026
- First submitted
- 27 Jan 2026
- Last updated
- 2 Mar 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Guselkumab Versus Ustekinumab in Stricturing Crohn's Disease: A Multicenter, Prospective, Observational Cohort Study
- ClinicalTrials.gov ID
- NCT07444060
- Acronym / sponsor ID
- 2025-1589
- Keywords
- Stricturing Crohn's Disease, Guselkumab, Ustekinumab
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Collaborators
- People's Hospital of Chongqing
- Study start
- 1 Mar 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2029 (estimated)
- First posted
- 2 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study intends to select patients with confirmed moderate-to-severe Crohn's disease (CD) and obstructive symptoms of intestinal stenosis, who have clear evidence of lumen stenosis caused by the disease itself through radiography or endoscopy. After the informed consent of the patients, comprehensive drug therapy with Guselkumab or Ustekinumab as the mainstay was performed. The basic information and medical history of the patients were collected, and the treatment process of the patients was followed up and recorded, and the drug regimen was adjusted according to the physician's experience and judgment. At different follow-up time points, blood, feces, tissue and other specimens of patients were collected according to the situation, and gastrointestinal endoscopy, imaging examination, laboratory index examination, self-assessment of subjects' symptoms, and nutritional risk screening were performed on the patients. This study evaluated the CD disease activity, obstructive symptoms, and radiographic or endoscopic remission in patients at different follow-up time points, and comprehensively evaluated the efficacy of ustekinumab in relieving stenotic CD and its related factors.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GUS | – | Drug: Guselkumab (GUS)Guselkumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease |
| UST | – | Drug: Ustekinumab (UST)Ustekinumab standard usage and optimized usage for the treatment of patients with symptomatic stricturing Crohn's disease |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who will initially receive Guselkumab or Ustekinumab for the treatment of stricturing Crohn's disease
Key inclusion criteria (5 listed)
- 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:
Key exclusion criteria (13 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Guselkumab (GUS)① Induction phase (Weeks 1-12): GUS 200 mg intravenously (IV) every 4 weeks for 3 doses, followed by a maintenance phase with GUS 100 mg subcutaneously (SC) every 8 weeks (for patients with all indicators within the normal range). ② Maintenance phase: Dosing adjustments shall be optimized based on the clinician's experience: If any disease activity occurs during the maintenance phase (e.g., suboptimal levels of CRP or FCP), administer GUS 200 mg SC every 4 weeks, or GUS 100 mg SC every 8 weeks plus enteral nutrition accounting for no more than 50% of the total daily energy intake. In case of persistent disease activity, administer intensive intravenous infusion of GUS 200 mg for 3 doses based on patient needs and shared decision-making. | Drug | GUS |
| Ustekinumab (UST)① Induction phase (Weeks 1-8): UST 6 mg/kg intravenously (IV) for 1 dose, followed by UST 90 mg subcutaneously (SC) every 8 weeks. A maintenance dose of 90 mg SC shall be administered every 8 or 12 weeks thereafter on a case-by-case basis. ② Experience-based dosing optimization and adjustment: If C-reactive protein (CRP) or fecal calprotectin (FCP) levels are suboptimal, two treatment approaches shall be adopted based on patient needs and shared decision-making: intravenous intensification therapy (predominantly 2 to 3 IV doses, i.e., 260 mg or 390 mg, with a follow-up visit at 8 weeks); or 90 mg SC with a shortened administration interval (with a follow-up visit at 4 to 6 weeks). ③ The duration of Exclusive Enteral Nutrition (EEN) use shall not exceed 2 weeks. If enteral nutrition support is required beyond 2 weeks, switch to Partial Enteral Nutrition (PEN), which shall account for less than 50% of the patient's total energy requirement. | Drug | UST |
Primary outcome
Continuation of ustekinumab
Time frame: up to 52 weeks
The primary endpoint was the success at week 52, defined as ustekinumab continuation with all the following criteria: (1) no use of a prohibited treatment (corticosteroids after the eight week following inclusion, parenteral nutrition, other anti-TNFs); (2) no endoscopic dilation; (3) no bowel surgery for resection of small bowel stricture; (4) no severe adverse events leading to ustekinumab withdrawal and (5) no study withdrawal whatever the reason.
3 secondary outcomes
CT stricture improvement
Time frame: at Week 0 and 52
General health improvement
Time frame: at Week 0, 8, 24 and 52
Number of Participants with surgery
Time frame: up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of CD - Crohn's Disease and Stricture; Bowel, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yan Chen (86+13757118653, chenyan72_72@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuation of ustekinumab (time frame: up to 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2026.