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

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.

After the study began, regular check-ups and evaluations were required when necessary or before medication administration. Venous blood samples were collected, or fecal collection boxes were provided for stool collection. When intestinal endoscopy was required for re-examination, one piece of normal and one piece of diseased intestinal mucosa tissue were collected each time. When surgery was required, two pieces of normal and two pieces of diseased intestinal mucosa tissue were collected each time. Sample collection does not affect the disease treatment and evaluation process. If any discomfort occurs during IL-23 inhibitor treatment, or if there are new changes in the condition or any unexpected situations, including hospitalization at other medical institutions, disability, etc., regardless of whether they are related to the study, participants should notify the investigator promptly to allow for judgment and appropriate medical treatment or advice to ensure safety.

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.

Sponsors & Collaborators

• Sixth Affiliated Hospital, Sun Yat-sen University

  lead OTHER

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-12-01

Primary Completion

2026-09-30

Completion

2026-10-10

FDA Device

Yes

Countries

• China

Study Locations