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

Official title

Analysis of the Efficacy and Safety of Interleukin-23 Monoclonal Antibody in Inflammatory Bowel Disease: A Prospective Study

Overview

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.

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 correspon
• 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 correspon

Primary outcome measures

• Steroid-Free Clinical Remission [Time frame: 12th to 16th week]

Secondary outcome measures (5)

• Clinical Response [Time frame: 12th to 16th week;52th to 54th week]
• Endoscopic Remission [Time frame: 12th to 16th week;52th to 54th week]
• Mucosal Healing [Time frame: 12th to 16th week;52th to 54th week]
• Radiological Remission [Time frame: 12th to 16th week;52th to 54th week]
• Radiological response [Time frame: 12th to 16th week;52th to 54th week]

Eligibility criteria

Inclusion criteria

• 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 criteria

• 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

China · 1 center

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou

Publications

• Khor B, Gardet A, Xavier RJ. Genetics and pathogenesis of inflammatory bowel disease. Nature. 2011 Jun 15;474(7351):307-17. doi: 10.1038/nature10209. PMID 21677747
• Verstockt B, Salas A, Sands BE, Abraham C, Leibovitzh H, Neurath MF, Vande Casteele N; Alimentiv Translational Research Consortium (ATRC). IL-12 and IL-23 pathway inhibition in inflammatory bowel disease. Nat Rev Gastroenterol Hepatol. 2023 Jul;20(7):433-446. doi: 10.1038/s41575-023-00768-1. Epub 2023 Apr 17. PMID 37069321
• Hart A, Panaccione R, Steinwurz F, Danese S, Hisamatsu T, Cao Q, Ritter T, Seidler U, Olurinde M, Vetter ML, Yee J, Yang Z, Wang Y, Johanns J, Han C, Sahoo A, Terry NA, Sands BE, D'Haens G; GRAVITI Study Group. Efficacy and Safety of Guselkumab Subcutaneous Induction and Maintenance in Participants With Moderately to Severely Active Crohn's Disease: Results From the Phase 3 GRAVITI Study. Gastroen PMID 40113101

Identifiers

NCT: NCT07216014 · 2025ZSLYEC-529

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗