Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety

PHASE4Not yet recruitingINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

October 8, 2025

Primary Completion Date

September 30, 2026

Study Completion Date

October 10, 2026

Conditions
Crohn's Disease and Ulcerative Colitis
Interventions
DRUG

Interleukin 23

After obtaining the patient's informed consent, the drug treatment mainly consisting of interleukin-23 monoclonal antibody was carried out. Basic information and medical history of the patients were collected, and the treatment process of the patients was followed up. The drug regimen was adjusted based on the physician's experience. Follow-up and disease assessment were conducted at 0, 4, 8, 16, 24, 48, and 54 weeks, respectively. Blood, stool, and tissue samples were collected at the corresponding follow-up time points for gastrointestinal endoscopy, imaging examinations, laboratory index tests, self-assessment of symptoms by the subjects, assessment of adverse reactions, and nutritional risk screening, etc. The efficacy and safety of IL-23 inhibitor treatment for CD or UC were comprehensively evaluated.

DEVICE

Interleukin 23

After obtaining the patient's informed consent, the drug treatment mainly consisting of interleukin-23 monoclonal antibody was carried out. Basic information and medical history of the patients were collected, and the treatment process of the patients was followed up. The drug regimen was adjusted based on the physician's experience. Follow-up and disease assessment were conducted at 0, 4, 8, 16, 24, 48, and 54 weeks, respectively. Blood, stool, and tissue samples were collected at the corresponding follow-up time points for gastrointestinal endoscopy, imaging examinations, laboratory index tests, self-assessment of symptoms by the subjects, assessment of adverse reactions, and nutritional risk screening, etc. The efficacy and safety of IL-23 inhibitor treatment for CD or UC were comprehensively evaluated.

All Listed Sponsors
lead

Sixth Affiliated Hospital, Sun Yat-sen University

OTHER