Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety
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 information and medical history were collected. The treatment process was followed, and the drug treatment plan was adjus
| Condition(s) | Crohn's Disease and Ulcerative Colitis |
|---|---|
| Status | Recruiting |
| Phase | Phase 4 |
| Study type | Interventional |
| 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 information and medical history were collected. The treatment process was followed, and the drug treatment plan was adjusted based on physician experience. Follow-up and disease assessments were conducted at 0, 4, 8, 16, 24, 48, and 54 weeks. At corresponding follow-up time points, blood, stool, and tissue samples were collected for gastrointestinal endoscopy, imaging examinations, laboratory tests, symptom self-assessment by participants, adverse reaction assessment, and nutritional risk screening. The efficacy and safety of IL-23 inhibitor treatment for CD or UC were comprehensively evaluated |
| Who can participate | Inclusion Criteria: 1. Male or female subjects aged between 18 and 65 years at the baseline visit; 2. 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); 3. 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; 4. The subjects fully understand the purpose of the trial, and should have a basic understanding |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Lead sponsor | Sixth Affiliated Hospital, Sun Yat-sen University |
| Locations | Guangzhou, Guangdong, China |
| Start date | 2025-12-01 |
| NCT ID | NCT07216014 |
| Official listing | https://clinicaltrials.gov/study/NCT07216014 |