Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-65
SponsorSixth Affiliated Hospital, Sun Yat-sen University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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;
Trial design
Design model
Single group
Treatments tested in this trial
Interleukin 23
DrugAfter 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.
Interleukin 23
DeviceAfter 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.
Treatment groups
200 Participants
are divided into 1 treatment groupGroup A: Inflammatory bowel diseaseExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Steroid-Free Clinical Remission
Clinical remission in CD is defined as a CDAI score of less than 150, achieved without the use of corticosteroids.Clinical remission in UC is defined as a modified Mayo score of 2 or less, with no individual subscore greater than 1, achieved without the use of corticosteroids.
Time frame
12th to 16th weekSecondary outcomes
1
Clinical Response
CD:A decrease in CDAI score by 70 points or more from baseline is considered a clinical response. UC: A decrease in the Modified Mayo Score by at least 30% and an absolute reduction of at least 3 points from baseline signifies a clinical response.
Time frame
12th to 16th week;52th to 54th week2
Endoscopic Remission
An SES-CD score of 2 or less indicates endoscopic remission. UC: An MES of 1 or less is defined as endoscopic remission.
Time frame
12th to 16th week;52th to 54th week3
Mucosal Healing
CD:An SES-CD score of 0 is indicative of mucosal healing. UC:An MES of 0 represents mucosal healing.
Time frame
12th to 16th week;52th to 54th week4
Radiological Remission
Defined as the complete disappearance or minimization of intestinal inflammation on imaging studies, signifying no visible lesions, normalized wall thickness, absence of strictures or obstructions, and no new areas of disease. Radiographic remission is an important indicator of deep remission in disease treatment goals.
Time frame
12th to 16th week;52th to 54th weekSponsors and contacts
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Source ClinicalTrials.gov