Trial studying safety and effects for Crohn's Disease and Ulcerative Colitis
Official title Interleukin-23 Monoclonal Antibody for Inflammatory Bowel Disease: Efficacy and Safety
ClinicalTrials.gov ID: NCT07216014
What this study is testing
What is Interleukin 23?
Interleukin 23 is an investigational medicine, being studied as a potential treatment for crohn's disease and ulcerative colitis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Male or female people 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...
- 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 people fully understand the purpose of the trial, and should have a basic understanding of the pharmacological effects of the trial drugs and the...
You likely can't join if
- 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...
- people who need surgery due to the condition or plan to undergo elective surgery during the study;
- Complicated with severe liver and kidney dysfunction;
See the full eligibility criteria
- Male or female people 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...
- 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...
- The people 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...
- 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;
- people 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Guangzhou, Guangdong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Guangzhou, Guangdong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.