Inflamatory Bowel DiseaseNCT07487311
A Prospective Cohort Study Evaluating the Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat Inflammatory Bowel Disease (IBD)
An observational study of Inflamatory Bowel Disease, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Read more about this study
- Who is it for?
- Ages 14 to 80 years
- Conditions the study is for
- Inflamatory Bowel Disease
- What is being tested?
- guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 7 Jan 2026to 31 Dec 2028
- 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 14 to 80 years
- All sexes
- Child, Adult, Older adult
Study population: Moderate to severe active Inflammatory bowel disease
Who may be able to join
- Age 14-80 years with confirmed diagnosis of IBD;
- Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2);
- Moderate to severe active IBD (CD: CDAI 220-450, SES-CD ≥6 or isolated ileal disease ≥4; UC: Baseline modified Mayo score (mMayo) of 4-9, rectal bleeding score ≥1, endoscopic score ≥2);
- Signed informed consent.
Who cannot join
- Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation;
- History of thromboembolism, severe hepatic or renal insufficiency, severe cytopenia;
- Prior intolerance to JAK inhibitors or IL-23 inhibitors.
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
Official title: Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.
- Conditions
- Inflamatory Bowel Disease
- Being tested
- guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)Drug
guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib)
What is being measured
The primary outcome is the main question the study is designed to answer.
12-week clinical response and 52-week endoscopic response
Measured: The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).
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 start7 Jan 2026
- Primary completion31 Dec 2027 (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.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07487311
- Sponsor's protocol ID
- 研2025-1622
- Status last verified
- Jan 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
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
- Efficacy and Safety of Guselkumab (GUS) With JAK Inhibitors in Patients With Difficult-To-Treat IBD
- ClinicalTrials.gov ID
- NCT07487311
- Acronym / sponsor ID
- 研2025-1622
- Conditions
- Inflamatory Bowel Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 7 Jan 2026 (actual)
- Primary completion
- 31 Dec 2027 (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.
Patients with refractory inflammatory bowel disease (IBD) show inadequate response to conventional biologics and small molecule drugs, with persistently active disease that severely impacts quality of life and long-term prognosis. Current treatment options are limited, and the substantial disease heterogeneity makes traditional randomized controlled trials difficult to implement in this population. This study aims to explore the efficacy and safety of guselkumab (GUS) with JAK inhibitors (such as upadacitinib/tofacitinib) in this patient population, providing novel therapeutic strategies for clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 14 to 80 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Moderate to severe active Inflammatory bowel disease
Key inclusion criteria (4 listed)
- Age 14-80 years with confirmed diagnosis of IBD;
- Meeting the definition of refractory IBD (1. Failure of at least two biologics with different mechanisms of action; 2. Crohn's disease with recurrence after two or more intestinal resections; 3. Complex perianal disease despite treatments 1 and 2);
Key exclusion criteria (3 listed)
- Active infection, abscess, malignancy, severe cardiopulmonary disease, pregnancy or lactation;
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), JAK inhibitors (such as upadacitinib/tofacitinib)guselkumab (GUS), JAK inhibitors (such as upadacitinib/tofacitinib) | Drug | – |
Primary outcome
12-week clinical response and 52-week endoscopic response
Time frame: The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).
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.
Related trials for Inflamatory Bowel Disease
Recruiting
Non-nutritive Sweeteners in Inflammatory Bowel Disease
Inflamatory Bowel Disease, Crohn Disease (CD)
Active, not recruiting
Physical Activity and Fitness in Pediatric Inflammatory Bowel Disease
Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis), Inflamatory Bowel Disease
RecruitingObservational study
Inflammatory Bowel Disease (IBD) Research Registry
Inflamatory Bowel Disease (Crohn's and Ulcerative Colitis)
Not yet recruitingObservational study
Screening Questionnaires and Musculoskeletal Ultrasound for Early Detection of Spondyloarthritis in IBD Patients
Inflamatory Bowel Disease, Spondylarthritis
RecruitingObservational study
Comparison of the Efficacy of Different Biologic Agents in Preventing Postoperative Endoscopic Recurrence of Crohn's Disease
Inflamatory Bowel Disease, Crohn Disease (CD)
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, 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 4 inclusion and 3 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?
12-week clinical response and 52-week endoscopic response (time frame: The composite endpoint achievement rate of 12-week clinical response (CDAI decrease ≥100) and 52-week endoscopic response (SES-CD improvement ≥50%).). 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.