Inflamatory Bowel DiseaseNCT07487480
A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
An observational study of Inflamatory Bowel Disease and Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Inflamatory Bowel Disease, Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
- What is being tested?
- Observation
- How many people
- 60 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2025to 31 Dec 2028
- How long will I take part?
- 2 Years
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will receive guselkumab according to the following schedule: Induction Phase (Weeks 0-12): Guselkumab 200 mg IV every 4 weeks (3 doses). Maintenance Phase (Weeks 12-52): Guselkumab 100 mg SC every 8 weeks. Adjustments may be made based on clinical response and physician judgment.
Who may be able to join
- Age 18-75 years.
- Diagnosis of Crohn's disease for at least 3 months.
- Moderate to severe disease activity (CDAI 220-450).
- Previous treatment with at least one standard dose of ustekinumab with documented:
- Primary non-response, or Secondary loss of response, or Intolerance leading to discontinuation.
- Willing and able to comply with all study visits and procedures.
Who cannot join
- Previous exposure to any anti-IL-23p19 therapy (including guselkumab).
- Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess (<8 weeks).
- History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection.
- Pregnancy, lactation, or planned pregnancy during the study period.
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
Center of Inflammatory Bowel Disease, Department of Gastroenterology, the Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Yan Chen, +86-571-87783777, chenyan72_72@zju.edu.cn
Shurong HU, +86-571-87783777, hushurong@zju.edu.cn
About this study
This is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and maintenance regimen over a total observation period of 52 weeks. The primary endpoint is the proportion of patients achieving clinical remission at Week 52. Secondary endpoints include clinical response, endoscopic improvement, biomarker normalization, quality of life assessment, and safety monitoring.
Read the detailed description
Crohn's disease is a chronic, progressive, and disabling inflammatory bowel disease. Ustekinumab, a monoclonal antibody targeting the p40 subunit of IL-12/23, is an established treatment option. However, a significant proportion of patients experience primary non-response, secondary loss of response, or intolerance. Guselkumab is a fully human monoclonal antibody that selectively targets the p19 subunit of IL-23, a key cytokine in the Th17-mediated inflammatory pathway in CD. While guselkumab has demonstrated efficacy in biologic-naïve or TNF-antagonist failed CD patients, real-world prospective data in ustekinumab-experienced patients are limited. This study aims to fill this evidence gap by providing prospective observational data on the effectiveness and safety of guselkumab in this specific patient population.
- Being tested
- Observation
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ObservationOther
observation
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients achieving clinical remission (CDAI <150 or HBI <4) at Week 52.
Measured: 52weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2026
- Study start10 Feb 2025
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inflamatory Bowel 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
- 60 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487480
- Sponsor's protocol ID
- 研2025-1623
- Status last verified
- Feb 2026
- First submitted
- 17 Mar 2026
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study on the Efficacy and Safety of Guselkumab in the Treatment of Crohn's Disease Patients Previously Treated With Ustekinumab
- ClinicalTrials.gov ID
- NCT07487480
- Acronym / sponsor ID
- 研2025-1623
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 10 Feb 2025 (actual)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 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 is a prospective, single-center, observational study aimed at evaluating the efficacy and safety of guselkumab in patients with moderate to severe Crohn's disease (CD) who have previously failed or were intolerant to ustekinumab therapy. The study plans to enroll approximately 60 participants aged 18-75 years. Participants will receive guselkumab treatment following a defined induction and maintenance regimen over a total observation period of 52 weeks. The primary endpoint is the proportion of patients achieving clinical remission at Week 52. Secondary endpoints include clinical response, endoscopic improvement, biomarker normalization, quality of life assessment, and safety monitoring.
Detailed description
Crohn's disease is a chronic, progressive, and disabling inflammatory bowel disease. Ustekinumab, a monoclonal antibody targeting the p40 subunit of IL-12/23, is an established treatment option. However, a significant proportion of patients experience primary non-response, secondary loss of response, or intolerance. Guselkumab is a fully human monoclonal antibody that selectively targets the p19 subunit of IL-23, a key cytokine in the Th17-mediated inflammatory pathway in CD. While guselkumab has demonstrated efficacy in biologic-naïve or TNF-antagonist failed CD patients, real-world prospective data in ustekinumab-experienced patients are limited. This study aims to fill this evidence gap by providing prospective observational data on the effectiveness and safety of guselkumab in this specific patient population.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will receive guselkumab according to the following schedule: Induction Phase (Weeks 0-12): Guselkumab 200 mg IV every 4 weeks (3 doses). Maintenance Phase (Weeks 12-52): Guselkumab 100 mg SC every 8 weeks. Adjustments may be made based on clinical response and physician judgment.
Key inclusion criteria (6 listed)
- Age 18-75 years.
- Diagnosis of Crohn's disease for at least 3 months.
- Moderate to severe disease activity (CDAI 220-450).
- Previous treatment with at least one standard dose of ustekinumab with documented:
- Primary non-response, or Secondary loss of response, or Intolerance leading to discontinuation.
Key exclusion criteria (4 listed)
- Previous exposure to any anti-IL-23p19 therapy (including guselkumab).
- Active intestinal infection, unremoved stenotic lesions with obstructive symptoms, short bowel syndrome, stoma, or recent abdominal abscess (<8 weeks).
- History of malignancy (except certain skin cancers), active tuberculosis, or severe opportunistic infection.
- Pregnancy, lactation, or planned pregnancy during the study period.
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 |
|---|---|---|
| Observationobservation | Other | – |
Primary outcome
Proportion of patients achieving clinical remission (CDAI <150 or HBI <4) at Week 52.
Time frame: 52weeks
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 23 Mar 2026.
- Individual participant dataSharing planned: No
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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 Inflamatory Bowel Disease and Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), 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 6 inclusion and 4 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 23 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 Shurong Hu, PhD (008619857407061, hushurong@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients achieving clinical remission (CDAI <150 or HBI <4) at Week 52. (time frame: 52weeks). 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 23 Mar 2026.