Phase 4 Crohn's Disease and Colitis Trial, Recruiting

Written by an AI model from the ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are between 19 and 80 years old
• You have been diagnosed with Crohn's disease that causes fistulas (abnormal tunnels) around the anal area, confirmed through medical tests and imaging
• You have never previously been treated with biological drugs (such as anti-TNF medicines) or experimental new drugs for this condition
• You have at least one fistula near the anal area that is actively draining
• You have already tried two or more standard treatments (such as antibiotics, drainage procedures, or immune-suppressing medicines) without enough improvement
• If you are a woman who could become pregnant, you agree to use contraception throughout the study and for at least 6 months after your last dose of the study medicine

Who may not be able to join:

• You are unable or unwilling to give written consent to participate in the study
• Your doctor believes you are likely to need bowel surgery within 12 weeks of starting the trial
• You currently have or have previously had a stoma (a surgically created opening in the abdomen for waste)
• You have short bowel syndrome (a condition where a large part of the small intestine is missing or removed)
• You have significant narrowing of the bowel or abscesses (pockets of infection) inside the abdomen that make participation unsafe (confirm with trial site)
• You have had bowel surgery within the past 6 months, or were hospitalised due to bowel narrowing or abdominal abscesses within the past 3 months
• You have fistulas connecting the bowel to the vagina, skin, or other parts of the bowel
• You have previously been treated with biological drugs (such as anti-TNF medicines) or experimental new drugs
• You have a history of serious allergic reactions to monoclonal antibody medicines (a type of biological drug)
• You are currently on steroid treatment, unless you are on a low dose (equivalent to prednisolone 20 mg/day or less) and your doctor has a plan to gradually reduce and stop it during the trial
• You currently have active tuberculosis (TB); however, if your TB was fully treated in the past, you may still be eligible
• You have been identified as having latent (inactive) tuberculosis during screening, unless you have completed or are in the process of completing the required treatment for latent TB
• You have tested positive for the hepatitis B surface antigen (HBsAg), or certain other hepatitis B blood markers above a specific level (confirm with trial site)
• You have tested positive for hepatitis C antibodies
• You have a history of HIV infection or have tested positive for HIV
• You have tested positive for a bowel infection called Clostridioides difficile
• You have a serious heart condition classified as NYHA Class III or IV (meaning significant or severe heart failure)
• You currently have or have previously had a disease affecting the protective covering of your nerves (a demyelinating disease, such as multiple sclerosis)
• You have been diagnosed with cancer in the past 5 years (with the exception of certain skin cancers or cervical cancer), or have had pre-cancerous changes in the bowel in the past 5 years
• You currently show signs of an active infection, or have been treated for an infection in the past 8 weeks
• You have previously had an organ transplant
• You are currently pregnant or breastfeeding
• You are not of Korean ethnic background based on family history
• Your doctor determines for any other reason that you are not suitable for the trial

Important: Always verify eligibility with the trial site directly before applying.