Crohn DiseasePhase 4NCT07310095
A Study to Evaluate the Efficacy of Guselkumab in Chinese Participants With Crohn's Disease (CD)
A Phase 4 study testing Guselkumab (GUS) in people with Crohn Disease, run by Xian-Janssen Pharmaceutical Ltd. at 5 sites in China.
Trial summary
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease
- What is being tested?
- Guselkumab (GUS)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 5 sitesChina
- Study dates
- 30 Dec 2025to 15 Nov 2027
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220
- Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks
- Initially responded to UST induction therapy and then lose response to UST
- During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
Who cannot join
- Received UST dose optimization or multiple intravenous therapy in maintenance phase
- Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
- Is currently enrolled in an interventional clinical study
- Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
- Have a current or be suspected to have an abscess
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
China5 sites, 5 recruiting
- Recruiting
The First Affiliated Hospital Sun Yat sen University
Guangzhou, 510060
- Recruiting
The Sixth Affiliated Hospital Sun Yat sen University
Guangzhou, 510655
- Recruiting
Sir Run Run Shaw Hospital Zhejiang University School of Medicine
Hangzhou, 310018
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, 230022
- Recruiting
Ruijin Hospital
Shanghai, 200031
About this study
Official title: Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
- Conditions
- Crohn Disease
- Being tested
- Guselkumab (GUS)
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guselkumab (GUS)Drug
Also called TREMFYA
Guselkumab will be administered intravenously or by subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| Guselkumab Treatment | Experimental | Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy. Receives: Drug: Guselkumab (GUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Clinical Remission At Week 48
Clinical remission is defined as less than (<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Measured: At Week 48
Secondary outcomes (11)
Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48
Clinical response is defined as greater than or equal to (>=) 100-point reduction from baseline in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Measured: At Weeks 12, 24 and 48
Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24
Clinical remission is defined as < 150-point reduction in CDAI score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
Measured: At Weeks 12 and 24
Percentage of Participants Achieving Endoscopic Response
Endoscopic response is defined as >= 50% improvement from baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) score. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease.
Measured: At Weeks 24 and 48
Percentage of Participants Achieving Endoscopic Remission
Endoscopic remission is defined as SES-CD less than or equal to (<=) 2 in any individual component. The SES-CD is based on the evaluation of 4 variables: (ulcers - scored according to size, proportion of the surface covered by ulcers according to extent, proportion of affected surface with any other lesions according to extent, stenosis [single or multiple, and whether the colonoscopy could pass through the narrow lumen]), each considered in 5 segments of the bowel (the ileum, ascending colon, transverse colon, descending colon, and rectum). An overall total SES-CD score is derived from the sum of all the component scores and can range from 0 to 60. Higher scores indicating severe disease.
Measured: At Weeks 24 and 48
Baseline Characteristics of Participants With Endoscopic Remission: Age
Baseline characteristics of participants (age) with endoscopic remission will be reported.
Measured: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Sex
Baseline characteristics of participants (sex) with endoscopic remission will be reported.
Measured: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Height
Baseline characteristics of participants (height) with endoscopic remission will be reported.
Measured: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Weight
Baseline characteristics of participants (weight) with endoscopic remission will be reported.
Measured: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications
Baseline characteristics of participants (history of advanced treatment, concomitant medications) with endoscopic remission will be reported.
Measured: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities
Baseline characteristics of participants (comorbidities) with endoscopic remission will be reported.
Measured: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures
Baseline characteristics of participants (surgeries and procedures such as apheresis) with endoscopic remission will be reported.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2025
- Study start30 Dec 2025
- Primary completion15 Sep 2027 (estimated)
- Study completion15 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 78 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xi'an Janssen Pharmaceutical Clinical Trial, Study director, Xi'an Janssen Pharmaceutical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07310095
- Sponsor's protocol ID
- CNTO1959CRD4007
- Status last verified
- Nov 2026
- First submitted
- 16 Dec 2025
- Last updated
- 3 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
Study at a glance
From the registry record, last updated by the sponsor on 3 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Guselkumab in Chinese Participants With Crohn's Disease Following Loss of Response to Ustekinumab
- ClinicalTrials.gov ID
- NCT07310095
- Acronym / sponsor ID
- CNTO1959CRD4007
- Conditions
- Crohn Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Xian-Janssen Pharmaceutical Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2025 (actual)
- Primary completion
- 15 Sep 2027 (estimated)
- Study completion
- 15 Nov 2027 (estimated)
- First posted
- 30 Dec 2025 (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.
The purpose of this study is to evaluate how well guselkumab works in participants with Crohn's disease (CD; a long-term condition causing severe inflammation of the intestinal tract) who no longer respond to treatment with ustekinumab.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Guselkumab Treatment | Experimental | Drug: Guselkumab (GUS)Participants will receive Guselkumab intravenously (IV) every 4 weeks during the induction phase, followed by subcutaneous (SC) administration of Guselkumab every 4 weeks from Week 12 through Week 44 as maintenance therapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has a confirmed diagnosis of Crohn's disease (CD)
- Diagnosed with active CD, as defined by baseline Crohn's Disease Activity Index (CDAI) score greater than or equal to (>=) 220
- Participants had received the ustekinumab (UST) induction phase and received maintenance therapy via subcutaneous (SC) injection every 8 weeks or every 12 weeks
- Initially responded to UST induction therapy and then lose response to UST
- During the screening period, participants are receiving UST treatment as the first line biologic or second line biologic
Key exclusion criteria (5 listed)
- Received UST dose optimization or multiple intravenous therapy in maintenance phase
- Participants with CD requiring urgent surgical or endoscopic intervention, or requiring elective surgery within 2 months
- Is currently enrolled in an interventional clinical study
- Complications of CD, such as symptomatic strictures or stenoses, short gut syndrome
- Have a current or be suspected to have an abscess
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)Also: TREMFYAGuselkumab will be administered intravenously or by subcutaneous injection. | Drug | Guselkumab Treatment |
Primary outcome
Percentage of Participants Achieving Clinical Remission At Week 48
Time frame: At Week 48
Clinical remission is defined as less than (<) 150-point reduction in Crohn's Disease Activity Index (CDAI) score. The CDAI is a validated multi-item measure of severity of illness derived as a weighted sum of 8 different Crohn's disease-related variables. The CDAI score was assessed by collecting information on 8 different Crohn's disease-related variables: extra-intestinal manifestations, abdominal mass, weight, hematocrit, total number of liquid stools, abdominal pain/cramping, use of antidiarrheal drug(s), and/or opiates, and general well-being. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities.
11 secondary outcomes
Percentage of Participants Achieving Clinical Response At Weeks 12, 24 and 48
Time frame: At Weeks 12, 24 and 48
Percentage of Participants Achieving Clinical Remission At Weeks 12 and 24
Time frame: At Weeks 12 and 24
Percentage of Participants Achieving Endoscopic Response
Time frame: At Weeks 24 and 48
Percentage of Participants Achieving Endoscopic Remission
Time frame: At Weeks 24 and 48
Baseline Characteristics of Participants With Endoscopic Remission: Age
Time frame: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Sex
Time frame: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Height
Time frame: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Weight
Time frame: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: History of Advanced Treatment, Concomitant Medications
Time frame: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Comorbidities
Time frame: Baseline
Baseline Characteristics of Participants With Endoscopic Remission: Surgeries and Procedures
Time frame: Baseline
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 3 Nov 2026.
- Individual participant dataSharing planned: Yes. The data sharing policy of Johnson \& Johnson Innovative Medicine is available at innovativemedicine.jnj.com/our-innovation/clinical-trials/transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
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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.
Xi'an Janssen Pharmaceutical Clinical Trial study director
Xi'an Janssen Pharmaceutical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Guselkumab (GUS) in people with Crohn Disease, run by Xian-Janssen Pharmaceutical Ltd. at 5 sites 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 5 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 3 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Study Contact (844-434-4210, Participate-In-This-Study1@its.jnj.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Clinical Remission At Week 48 (time frame: At Week 48). 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 3 Nov 2026.