RecruitingNot a traditional drug phaseobservationalRules rewrite

Not a traditional drug phase: testing IL-23 inhibitor for Crohn's Disease

The goal of this watch-and-measure (no experimental treatment required) 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?

Official registry: https://clinicaltrials.gov/study/NCT07545317 · Sixth Affiliated Hospital, Sun Yat-sen University · enrollment listed as 665

What this phase means

This is an observational study. You are not assigned a new experimental drug. Researchers measure what already happens in your care or in daily life.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

This listing is observational (StudyType). The registry does not assign a new experimental drug as the study intervention.

They plan to enroll about 665 people at Guangzhou. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

Efficacy and Safety of IL-23 Inhibitors in Patients With Active Crohn's Disease: A Prospective, Multicenter, Observational Study

Interventions: IL-23 inhibitor, TNF inhibitors

Primary outcome (registry wording): Clinical Remission Rate

Who it is for (from inclusion criteria)

Ages 18 Years 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
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-who have not tried this kind of treatment before 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

Who the registry excludes

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

Public study contact (from the registry)

Wei Wang, MD & PhD

+86-020-82514458

weiwang0303@gmail.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

The Sixth Affiliated Hospital, Sun Yat-sen University — Guangzhou, Guangdong, China (recruiting)

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FAQ about this NCT record

Is NCT07545317 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07545317?

Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07545317?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary