Status:
NOT_YET_RECRUITING
Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety
Lead Sponsor:
Sixth Affiliated Hospital, Sun Yat-sen University
Conditions:
Crohn's Disease and Ulcerative Colitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
Patients diagnosed with moderate to severe CD or UC by the end of the study period were selected. After obtaining informed consent, treatment with infliximab-based drugs was initiated. Basic patient i...
Eligibility Criteria
Inclusion
- Male or female subjects aged between 18 and 65 years at the baseline visit;
- Patients diagnosed with CD and UC as per the Chinese Guidelines for the Diagnosis and Treatment of Crohn's Disease (2023 · Guangzhou) and the Chinese Guidelines for the Diagnosis and Treatment of Ulcerative Colitis (2023 · Xi'an);
- If the subject is a fertile female, a pregnancy test must be conducted at the baseline to rule out pregnancy. The entire trial process must follow the contraceptive recommendations of this project (see below); women without reproductive potential (defined as post-menopause or permanent surgical sterilization) do not need to undergo a pregnancy test at the baseline;
- The subjects fully understand the purpose of the trial, and should have a basic understanding of the pharmacological effects of the trial drugs and the possible adverse reactions; in accordance with the spirit of the Helsinki Declaration, they voluntarily sign the informed consent form and comply with the requirements of this research protocol.
Exclusion
- Diagnosed with ischemic enteritis, infectious enteritis, radiation enteritis, NSAIDs-related enteritis, and other autoimmune enteropathies;
- Unable to administer IL-23 inhibitors regularly by intravenous or subcutaneous injection;
- Evidence of toxic megacolon was detected during screening;
- Previously underwent small bowel resection, ileocecal resection, extensive colon resection, subtotal resection or total colon resection, rectal resection, ileostomy, colostomy;
- Subjects who need surgery due to the condition or plan to undergo elective surgery during the study;
- Complicated with severe liver and kidney dysfunction;
- Complicated with active bacterial or viral infections, chronic infections;
- Biologic agents are contraindicated such as active tuberculosis with positive chest X-ray or strongly positive tuberculin skin test, active tuberculosis within the past five years, myocardial infarction, heart failure or demyelinating neurological diseases;
- Had severe opportunistic infections during screening, such as severe or recurrent herpes zoster, active cytomegalovirus infection, Pneumocystis jirovecii, Histoplasma capsulatum, etc. infections;
- Have a history of gastrointestinal dysplasia, or any biopsy during endoscopic examination has revealed dysplasia, excluding completely resected low-grade dysplastic lesions; Patients with a known history of lymphoid tissue proliferative diseases (including lymphoma), or with signs and symptoms of lymphoid tissue proliferative diseases (such as lymphadenopathy and/or splenomegaly); Patients with current or past malignant tumors.
Key Trial Info
Start Date :
December 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 10 2026
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT07216014
Start Date
December 1 2025
End Date
October 10 2026
Last Update
November 28 2025
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