Crohn's DiseaseNCT07545317
Real-World Study of IL-23 Inhibitors in Active Crohn's Disease
An observational study of Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University at 1 site in China.
Trial summary
The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are: What proportion of participants achieve clinical remission at Week 12 after starting treatment with an… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- IL-23 inhibitor and TNF inhibitors
- How many people
- 665 participants
- Where
- 1 siteChina
- Study dates
- 16 Apr 2026to 31 Aug 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with active Crohn's disease consecutively enrolled from participating centers in routine clinical practice. The main study population is a prospective multicenter cohort of patients initiating IL-23 inhibitor therapy, including guselkumab or risankizumab. A concurrent prospective cohort of bio-naive patients initiating TNF inhibitor therapy will also be enrolled for a nested comparative analysis. Participants must have objective evidence of active disease and satisfy protocol-defined eligibility criteria.
Who may be able to join
- Age 18 to 75 years
- Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and/or histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria
- Active Crohn's disease with a baseline Crohn's Disease Activity Index (CDAI) score of 150 to 450, and at least one of the following objective inflammatory findings: (1) Endoscopic activity within 1 month before enrollment, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) >=6 for ileocolonic or colonic disease, or SES-CD >=4 for isolated ileal disease, (2) Active intestinal inflammation on bowel ultrasound, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), (3) Serum C-reactive protein (CRP) above the upper limit of normal, (4) Fecal calprotectin (FC) >=250 ug/g
- Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors
- Prior treatment history for the IL-23 inhibitor cohort may include biologic-naive or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted
- If receiving concomitant medications, doses should be stable for at least 2 to 4 weeks before enrollment, including oral corticosteroids, azathioprine, 6-mercaptopurine, methotrexate, or 5-aminosalicylic acid
- Able to understand the study procedures, provide written informed consent, and comply with follow-up and biospecimen collection requirements
- Additional criteria for the concurrent prospective TNF inhibitor cohort used in the nested comparative analysis: (1) Participants must be bio-naive, defined as no prior exposure to any biologic agent (including TNF inhibitors, vedolizumab, ustekinumab, etc.) or targeted small-molecule therapy (such as JAK inhibitors), (2) Participants must also meet Inclusion Criteria 1, 2, 3, 6, and 7 above, (3) Participants must be planned to initiate TNF inhibitor therapy in routine clinical practice
Who cannot join
- Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents
- Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis
- Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction
- Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe/recurrent infection history
- Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence
- Pregnancy, breastfeeding, or planned pregnancy during the study period
- Severe systemic disease or other condition that, in the investigator's judgment, makes participation unsuitable, including severe cardiac, hepatic, or renal dysfunction, uncontrolled autoimmune disease, or psychiatric disease affecting adherence
- Inability to complete follow-up, poor compliance, or recent participation in another interventional clinical trial
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
The Sixth Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Wei Wang, MD, +86-020-82514458, weiwang0303@gmail.com
About this study
Official title: Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study
The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are:
- What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?
- What are the clinical, endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment?
Read more
This is not a head-to-head randomized study. Treatments are selected by treating physicians as part of routine clinical care. For a nested comparative analysis, bio-naive participants treated with IL-23 inhibitors will be compared with a concurrent prospective cohort of bio-naive participants treated with TNF inhibitors to evaluate comparative effectiveness and safety.
Participants will:
- Receive treatment chosen by their treating physicians as part of routine clinical care, including IL-23 inhibitors or TNF inhibitors
- Attend study follow-up visits during induction and maintenance, including assessments at baseline, Week 12 and Week 52
- Undergo routine clinical evaluations, which may include symptom assessment, laboratory tests, endoscopy, and imaging, as available
- Be monitored for adverse events and treatment changes during the study
- Optionally provide blood, stool, and other available samples for exploratory biomarker, microbiome, metabolomic, and other multi-omics analyses related to treatment response
Read the detailed description
This is a prospective, multicenter, real-world observational cohort study designed to evaluate the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in routine clinical practice. The primary study population consists of patients who initiate treatment with an IL-23 inhibitor, including guselkumab or risankizumab, as part of physician-directed standard care. Participants will be consecutively enrolled and followed according to the study protocol.
This is not a head-to-head randomized controlled trial. Treatment is not assigned by the study protocol; instead, therapy is selected by treating physicians in routine clinical practice. In addition to the primary IL-23 inhibitor cohort, a concurrent prospective cohort of bio-naive patients initiating TNF inhibitor therapy will be enrolled during the same study period for a nested comparative analysis. This comparative cohort is intended to support evaluation of comparative effectiveness and safety between bio-naive IL-23 inhibitor-treated participants and bio-naive TNF inhibitor-treated participants.
Eligible participants must have active Crohn's disease with objective evidence of intestinal inflammation, as defined by protocol-specified clinical, endoscopic, imaging, and/or biomarker criteria. For the IL-23 inhibitor cohort, both biologic-naive and biologic-experienced patients may be included, provided they have not previously received IL-23 inhibitor therapy. For the concurrent TNF inhibitor comparative cohort, participants must be bio-naive and must otherwise meet the relevant protocol-defined eligibility criteria.
The primary outcome is the clinical remission rate at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score of less than 150. Secondary outcomes include clinical response, endoscopic remission, endoscopic response, PRO-2 remission, corticosteroid-free clinical remission, corticosteroid-free endoscopic remission, deep remission, mucosal healing, bowel ultrasound inflammatory improvement, C-reactive protein normalization, fecal calprotectin normalization, and safety outcomes assessed during induction and maintenance follow-up. Safety assessments include adverse events, serious adverse events, special safety events, and treatment discontinuation or switching.
Participants will undergo protocol-defined follow-up assessments during induction and maintenance, including evaluations at baseline, Week 12 and Week 52, as available in routine clinical practice. Assessments may include symptom evaluation, laboratory testing, endoscopy, bowel ultrasound, and other clinically indicated imaging studies. Optional biospecimen collection may include blood, stool, and clinically available intestinal tissue samples.
Exploratory analyses will examine integrated multi-omics features associated with treatment response, including fecal microbiome, blood and fecal metabolomic, and intestinal tissue transcriptomic data in participants with available samples. These analyses are intended to identify candidate biologic features associated with clinical remission, endoscopic outcomes, biomarker improvement, and safety outcomes over time.
This study is intended to generate prospective real-world evidence regarding the effectiveness and safety of IL-23 inhibitors in active Crohn's disease and to provide additional comparative evidence from a concurrent prospective bio-naive TNF inhibitor cohort in nested analyses.
- Conditions
- Crohn's Disease
- Being tested
- IL-23 inhibitor, TNF inhibitors
- Keywords
- Crohn's disease, IL-23 inhibitor, TNF inhibitor, Bio-naive, Real-world study, Observational cohort, Clinical remission, Endoscopic remission
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IL-23 inhibitorDrug
Participants in this observational study receive IL-23 inhibitor therapy as part of routine clinical care, including guselkumab or risankizumab according to local practice and physician judgment. Treatment is not assigned by the study protocol. This drug exposure is the primary focus of the study for evaluation of effectiveness and safety in active Crohn's disease.
TNF inhibitorsDrug
Participants in the comparative cohort receive TNF inhibitor therapy as part of routine clinical care, including infliximab or adalimumab according to local practice and physician judgment. Treatment is not assigned by the study protocol. This drug exposure is included for the concurrent prospective comparative cohort used in the nested comparative analysis.
| Study group | Role | What they receive |
|---|---|---|
| IL-23 Inhibitor Cohort | Adults with active Crohn's disease who initiate treatment with an IL-23 inhibitor, including guselkumab or risankizumab, in routine clinical practice. This is the primary prospective cohort of the study and will be used to evaluate the effectiveness and safety of IL-23 inhibitors. A bio-naive subgroup within this cohort will be included in a nested comparative analysis with a concurrent prospective TNF inhibitor cohort. Receives: Drug: IL-23 inhibitor | |
| TNF Inhibitor Comparative Cohort | Bio-naive adults with active Crohn's disease who initiate treatment with a TNF inhibitor in routine clinical practice and are prospectively followed during the same study period. This is a concurrent prospective comparative cohort enrolled specifically for the nested comparative analysis with the bio-naive subgroup of the IL-23 inhibitor cohort. Receives: Drug: TNF inhibitors |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Remission Rate
Proportion of participants achieving clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score <150.
Measured: Week 12
Secondary outcomes (14)
Clinical Response Rate
Proportion of participants achieving clinical response, defined as a decrease of at least 100 points in Crohn's Disease Activity Index (CDAI) from baseline or CDAI <150.
Measured: Weeks 12 and 52
Endoscopic Remission Rate
Proportion of participants achieving endoscopic remission, defined as a Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≤3.
Measured: Weeks 12 and 48
Endoscopic Response Rate
Proportion of participants achieving endoscopic response, defined as a decrease of more than 50% in SES-CD from baseline or SES-CD ≤3.
Measured: Weeks 12 and 52
Corticosteroid-Free Clinical Remission Rate
Proportion of participants achieving clinical remission without corticosteroid therapy, defined as CDAI <150 in the absence of systemic corticosteroid use.
Measured: Weeks 12 and 52
Corticosteroid-Free Endoscopic Remission Rate
Proportion of participants achieving endoscopic remission without corticosteroid therapy, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≤3 in the absence of systemic corticosteroid use.
Measured: Weeks 12 and 52
Deep Remission Rate
Proportion of participants achieving both clinical remission and endoscopic remission.
Measured: Weeks 12 and 52
Mucosal Healing Rate
Proportion of participants achieving mucosal healing, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) score <3 with an ulcer subscore of 0, excluding the effect of stricture scoring.
Measured: Weeks 12 and 52
Bowel Ultrasound Inflammatory Improvement Rate
Proportion of participants achieving bowel ultrasound inflammatory improvement, defined as bowel wall thickness ≤3 mm and/or a decrease of at least 1 grade in bowel wall vascularity assessed by Limberg score, compared with baseline.
Measured: Weeks 12 and 52
C-Reactive Protein Normalization Rate
Proportion of participants achieving normalization of C-reactive protein (CRP) at each assessment time point, defined as CRP within the normal range according to the local laboratory standard.
Measured: Weeks 12 and 52
Fecal Calprotectin Normalization Rate
Proportion of participants achieving normalization of fecal calprotectin (FC) at each assessment time point, defined as FC <250 μg/g.
Measured: Weeks 12 and 52
Trough Concentration of IL-23 Inhibitor
Measured trough concentration of IL-23 inhibitor therapy at each assessment time point, if available. Exploratory analyses will assess its association with clinical and endoscopic outcomes.
Measured: Weeks 12 and 52
Adverse Events
Incidence of adverse events from treatment initiation through Week 12 and through Week 52, graded according to CTCAE version 5.0.
Measured: Weeks 12 and 52
Serious Adverse Events
Incidence of serious adverse events from treatment initiation through Week 12 and through Week 52, defined as events resulting in death, are life-threatening, require unplanned hospitalization or prolongation of hospitalization, result in persistent or significant disability, or are considered medically important by the investigator.
Measured: Weeks 12 and 52
Special Safety Events
Incidence of prespecified safety events of special interest from treatment initiation through Week 12 and through Week 52, including serious infection, opportunistic infection, tuberculosis, herpes zoster, thrombotic events, and liver function abnormalities.
Measured: Weeks 12 and 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2026
- Study start16 Apr 2026
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Sixth Affiliated Hospital, Sun Yat-sen UniversityThe 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
- 665 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi Min, Sixth Affiliated Hospital, Sun Yat-sen University
- Investigators
- Wei Wang, MD, Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07545317
- Sponsor's protocol ID
- 2026ZSLYEC-203
- Status last verified
- Apr 2026
- First submitted
- 15 Apr 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The plan for sharing individual participant data has not yet been finalized. Any future data sharing will depend on institutional policy, ethics committee approval, participant consent, data de-identification requirements, and applicable regulations.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study
- ClinicalTrials.gov ID
- NCT07545317
- Acronym / sponsor ID
- 2026ZSLYEC-203
- Conditions
- Crohn's Disease
- Keywords
- Crohn's disease, IL-23 inhibitor, TNF inhibitor, Bio-naive, Real-world study, Observational cohort, Clinical remission, Endoscopic remission
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 665 participants (estimated)
- Lead sponsor
- Sixth Affiliated Hospital, Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 16 Apr 2026 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 22 Apr 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.
The goal of this observational study is to learn about the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in real-world clinical practice. The main questions it aims to answer are:
- What proportion of participants achieve clinical remission at Week 12 after starting treatment with an IL-23 inhibitor?
- What are the clinical, endoscopic, biomarker, imaging, and safety outcomes during induction and maintenance treatment?
This is not a head-to-head randomized study. Treatments are selected by treating physicians as part of routine clinical care. For a nested comparative analysis, bio-naive participants treated with IL-23 inhibitors will be compared with a concurrent prospective cohort of bio-naive participants treated with TNF inhibitors to evaluate comparative effectiveness and safety.
Participants will:
- Receive treatment chosen by their treating physicians as part of routine clinical care, including IL-23 inhibitors or TNF inhibitors
- Attend study follow-up visits during induction and maintenance, including assessments at baseline, Week 12 and Week 52
- Undergo routine clinical evaluations, which may include symptom assessment, laboratory tests, endoscopy, and imaging, as available
- Be monitored for adverse events and treatment changes during the study
- Optionally provide blood, stool, and other available samples for exploratory biomarker, microbiome, metabolomic, and other multi-omics analyses related to treatment response
Detailed description
This is a prospective, multicenter, real-world observational cohort study designed to evaluate the effectiveness and safety of IL-23 inhibitors in adults with active Crohn's disease in routine clinical practice. The primary study population consists of patients who initiate treatment with an IL-23 inhibitor, including guselkumab or risankizumab, as part of physician-directed standard care. Participants will be consecutively enrolled and followed according to the study protocol.
This is not a head-to-head randomized controlled trial. Treatment is not assigned by the study protocol; instead, therapy is selected by treating physicians in routine clinical practice. In addition to the primary IL-23 inhibitor cohort, a concurrent prospective cohort of bio-naive patients initiating TNF inhibitor therapy will be enrolled during the same study period for a nested comparative analysis. This comparative cohort is intended to support evaluation of comparative effectiveness and safety between bio-naive IL-23 inhibitor-treated participants and bio-naive TNF inhibitor-treated participants.
Eligible participants must have active Crohn's disease with objective evidence of intestinal inflammation, as defined by protocol-specified clinical, endoscopic, imaging, and/or biomarker criteria. For the IL-23 inhibitor cohort, both biologic-naive and biologic-experienced patients may be included, provided they have not previously received IL-23 inhibitor therapy. For the concurrent TNF inhibitor comparative cohort, participants must be bio-naive and must otherwise meet the relevant protocol-defined eligibility criteria.
The primary outcome is the clinical remission rate at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score of less than 150. Secondary outcomes include clinical response, endoscopic remission, endoscopic response, PRO-2 remission, corticosteroid-free clinical remission, corticosteroid-free endoscopic remission, deep remission, mucosal healing, bowel ultrasound inflammatory improvement, C-reactive protein normalization, fecal calprotectin normalization, and safety outcomes assessed during induction and maintenance follow-up. Safety assessments include adverse events, serious adverse events, special safety events, and treatment discontinuation or switching.
Participants will undergo protocol-defined follow-up assessments during induction and maintenance, including evaluations at baseline, Week 12 and Week 52, as available in routine clinical practice. Assessments may include symptom evaluation, laboratory testing, endoscopy, bowel ultrasound, and other clinically indicated imaging studies. Optional biospecimen collection may include blood, stool, and clinically available intestinal tissue samples.
Exploratory analyses will examine integrated multi-omics features associated with treatment response, including fecal microbiome, blood and fecal metabolomic, and intestinal tissue transcriptomic data in participants with available samples. These analyses are intended to identify candidate biologic features associated with clinical remission, endoscopic outcomes, biomarker improvement, and safety outcomes over time.
This study is intended to generate prospective real-world evidence regarding the effectiveness and safety of IL-23 inhibitors in active Crohn's disease and to provide additional comparative evidence from a concurrent prospective bio-naive TNF inhibitor cohort in nested analyses.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| IL-23 Inhibitor Cohort | – | Drug: IL-23 inhibitorAdults with active Crohn's disease who initiate treatment with an IL-23 inhibitor, including guselkumab or risankizumab, in routine clinical practice. This is the primary prospective cohort of the study and will be used to evaluate the effectiveness and safety of IL-23 inhibitors. A bio-naive subgroup within this cohort will be included in a nested comparative analysis with a concurrent prospective TNF inhibitor cohort. |
| TNF Inhibitor Comparative Cohort | – | Drug: TNF inhibitorsBio-naive adults with active Crohn's disease who initiate treatment with a TNF inhibitor in routine clinical practice and are prospectively followed during the same study period. This is a concurrent prospective comparative cohort enrolled specifically for the nested comparative analysis with the bio-naive subgroup of the IL-23 inhibitor cohort. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with active Crohn's disease consecutively enrolled from participating centers in routine clinical practice. The main study population is a prospective multicenter cohort of patients initiating IL-23 inhibitor therapy, including guselkumab or risankizumab. A concurrent prospective cohort of bio-naive patients initiating TNF inhibitor therapy will also be enrolled for a nested comparative analysis. Participants must have objective evidence of active disease and satisfy protocol-defined eligibility criteria.
Key inclusion criteria (8 listed)
- Age 18 to 75 years
- Diagnosis of Crohn's disease based on clinical presentation, endoscopy, imaging, and/or histopathology, consistent with ECCO criteria or Chinese IBD consensus criteria
- Active Crohn's disease with a baseline Crohn's Disease Activity Index (CDAI) score of 150 to 450, and at least one of the following objective inflammatory findings: (1) Endoscopic activity within 1 month before enrollment, defined as Simple Endoscopic Score for Crohn's Disease (SES-CD) >=6 for ileocolonic or colonic disease, or SES-CD >=4 for isolated ileal disease, (2) Active intestinal inflammation on bowel ultrasound, computed tomography enterography (CTE), or magnetic resonance enterography (MRE), (3) Serum C-reactive protein (CRP) above the upper limit of normal, (4) Fecal calprotectin (FC) >=250 ug/g
- Planned initiation of IL-23 inhibitor therapy in routine clinical practice, including guselkumab or risankizumab, with no prior exposure to IL-23 inhibitors
- Prior treatment history for the IL-23 inhibitor cohort may include biologic-naive or biologic-experienced patients; prior exposure to TNF inhibitors, vedolizumab, or ustekinumab is permitted
Key exclusion criteria (8 listed)
- Prior exposure to any IL-23 inhibitor, including guselkumab, risankizumab, mirikizumab, or other IL-23-targeted agents
- Diagnosis of inflammatory bowel disease other than Crohn's disease, or other intestinal disorders that may confound diagnosis, including ulcerative colitis, IBD-unclassified, intestinal tuberculosis, ischemic colitis, or radiation enteritis
- Crohn's disease requiring urgent surgery or associated with severe complications, including active bowel perforation, uncontrolled fistula with severe infection, or complete bowel obstruction
- Active infection or high-risk infectious condition, including active tuberculosis, latent tuberculosis without appropriate prophylaxis, active hepatitis B or C, HIV infection, or severe/recurrent infection history
- Current or prior malignancy, except adequately treated non-melanoma skin cancer or cervical carcinoma in situ with no evidence of recurrence
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 |
|---|---|---|
| IL-23 inhibitorParticipants in this observational study receive IL-23 inhibitor therapy as part of routine clinical care, including guselkumab or risankizumab according to local practice and physician judgment. Treatment is not assigned by the study protocol. This drug exposure is the primary focus of the study for evaluation of effectiveness and safety in active Crohn's disease. | Drug | IL-23 Inhibitor Cohort |
| TNF inhibitorsParticipants in the comparative cohort receive TNF inhibitor therapy as part of routine clinical care, including infliximab or adalimumab according to local practice and physician judgment. Treatment is not assigned by the study protocol. This drug exposure is included for the concurrent prospective comparative cohort used in the nested comparative analysis. | Drug | TNF Inhibitor Comparative Cohort |
Primary outcome
Clinical Remission Rate
Time frame: Week 12
Proportion of participants achieving clinical remission at Week 12, defined as a Crohn's Disease Activity Index (CDAI) score <150.
14 secondary outcomes
Clinical Response Rate
Time frame: Weeks 12 and 52
Endoscopic Remission Rate
Time frame: Weeks 12 and 48
Endoscopic Response Rate
Time frame: Weeks 12 and 52
Corticosteroid-Free Clinical Remission Rate
Time frame: Weeks 12 and 52
Corticosteroid-Free Endoscopic Remission Rate
Time frame: Weeks 12 and 52
Deep Remission Rate
Time frame: Weeks 12 and 52
Mucosal Healing Rate
Time frame: Weeks 12 and 52
Bowel Ultrasound Inflammatory Improvement Rate
Time frame: Weeks 12 and 52
C-Reactive Protein Normalization Rate
Time frame: Weeks 12 and 52
Fecal Calprotectin Normalization Rate
Time frame: Weeks 12 and 52
Trough Concentration of IL-23 Inhibitor
Time frame: Weeks 12 and 52
Adverse Events
Time frame: Weeks 12 and 52
Serious Adverse Events
Time frame: Weeks 12 and 52
Special Safety Events
Time frame: Weeks 12 and 52
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 9 Jul 2026.
- Individual participant dataSharing planned: Undecided. The plan for sharing individual participant data has not yet been finalized. Any future data sharing will depend on institutional policy, ethics committee approval, participant consent, data de-identification requirements, and applicable regulations.
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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.
Wei Wang, MD principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
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 Crohn's Disease, run by Sixth Affiliated Hospital, Sun Yat-sen University 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 8 inclusion and 8 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 9 Jul 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 Wei Wang, MD & PhD (+86-020-82514458, weiwang0303@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Remission Rate (time frame: Week 12). 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 9 Jul 2026.