IL-23 monoclonal antibody treatment for Crohn's disease and ulcerative colitis

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

This trial will test if an IL-23 monoclonal antibody helps adults aged 18–65 with moderate to severe Crohn's disease or ulcerative colitis.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 200 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Sixth Affiliated Hospital, Sun Yat-sen University (Academic / other)
• Drugs / interventions: radiation, infliximab
• Locations: 1 site (Guangzhou, Guangdong)
• Trial ID: NCT07216014 on ClinicalTrials.gov

What this trial studies

This phase 4 study enrolls adults diagnosed with moderate to severe Crohn's disease or ulcerative colitis according to Chinese guidelines and treats them with an IL-23 monoclonal antibody. Treatment is initiated and adjusted by physicians, with clinical visits and evaluations at weeks 0, 4, 8, 16, 24, 48, and 54. At those visits the study collects blood, stool, and tissue samples and performs endoscopy, imaging, laboratory tests, symptom self-assessments, adverse event monitoring, and nutritional risk screening. The protocol is focused on real-world safety and effectiveness data gathered during routine clinical care.

Who should consider this trial

Good fit: Adults 18–65 years old with a confirmed diagnosis of moderate to severe Crohn's disease or ulcerative colitis who can attend regular in-person visits and provide informed consent.

Not a fit: Patients with mild disease, those outside the 18–65 age range, pregnant women, or those with contraindications to IL-23 therapy are less likely to benefit from this treatment.

Why it matters

Potential benefit: If effective, this therapy could help more patients achieve remission, reduce flare-ups, and decrease reliance on steroids or surgery.

How similar studies have performed: Other IL-23–targeting antibodies (for example ustekinumab and risankizumab) have shown benefit in prior Crohn's disease and ulcerative colitis trials.

Eligibility criteria

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 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:

1. Diagnosed with ischemic enteritis, infectious enteritis, radiation enteritis, NSAIDs-related enteritis, and other autoimmune enteropathies;
2. Unable to administer IL-23 inhibitors regularly by intravenous or subcutaneous injection;
3. Evidence of toxic megacolon was detected during screening;
4. Previously underwent small bowel resection, ileocecal resection, extensive colon resection, subtotal resection or total colon resection, rectal resection, ileostomy, colostomy;
5. Subjects who need surgery due to the condition or plan to undergo elective surgery during the study;
6. Complicated with severe liver and kidney dysfunction;
7. Complicated with active bacterial or viral infections, chronic infections;
8. 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;
9. Had severe opportunistic infections during screening, such as severe or recurrent herpes zoster, active cytomegalovirus infection, Pneumocystis jirovecii, Histoplasma capsulatum, etc. infections;
10. 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.

Where this trial is running

Guangzhou, Guangdong

• The Sixth Affiliated Hospital of Sun Yat-sen University — Guangzhou, Guangdong, China (Recruiting)

Study contacts

• Study coordinator: Jiayin Yao, Doctor

Conditions Crohn's Disease and Ulcerative Colitis; Interleukin 23