Phase 2 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:

• People aged 18 to 65 years old (male or female).
• People who have been diagnosed with Crohn's Disease at least 6 months before the trial's screening visit, confirmed through medical records showing symptoms, imaging results, tissue biopsy findings, or by ruling out similar conditions.
• People whose Crohn's Disease activity score (called a CDAI score) falls between 150 and 450 at the screening visit, indicating mild to moderate disease.
• People who are either not currently on any treatment for Crohn's Disease, or who have been on a stable treatment plan for at least 3 months before screening.
• People who are willing to keep their current treatment plan (or no treatment) unchanged for the entire duration of the study.
• People who have blood test results at screening showing elevated inflammation markers (specifically, a CRP level of 1 mg/L or higher, and/or an ESR result above a certain level depending on sex — confirm details with trial site).
• People who can provide recent diagnostic imaging records (such as endoscopy, colonoscopy, MRI, or ultrasound) from within the past 3 years.
• Female participants of childbearing potential who are not pregnant, do not plan to become pregnant during the study or for 6 months after the last dose, and who are using an accepted form of contraception (such as hormonal contraception, an intrauterine device, or a barrier method).
• Male participants whose partners could become pregnant, where the couple uses an accepted form of contraception during the study and for 6 months after the last dose.
• People who are willing and able to follow all trial requirements and procedures.
• People who have voluntarily signed an informed consent form before any trial-related procedures begin.

Who may not be able to join:

• People whose blood test results at screening fall outside acceptable ranges for white blood cell count, neutrophil count, sodium, fasting glucose, potassium, kidney function markers (BUN and creatinine), or the ratio of those kidney markers (confirm specific values with trial site).
• People whose CDAI score is below 150 or above 450 at the screening visit.
• People who have abnormal vital signs at the screening visit, as assessed by the trial investigator.
• People with serious heart conditions, including severe heart failure, uncontrolled irregular heartbeat, a heart attack within the past 6 months, or uncontrolled high blood pressure.
• People with serious lung conditions, including severe COPD, pulmonary fibrosis, or a blood clot in the lungs or legs within the past 6 months.
• People with one or more significant uncontrolled ongoing medical conditions, including uncontrolled diabetes, rheumatoid arthritis, lupus, or multiple sclerosis.
• People with any active cancer, including certain skin cancers (basal cell carcinoma, squamous cell carcinoma, or melanoma).
• People who have had a cancer diagnosis within the past 5 years, unless it was fully treated with no recurrence.
• People with a known alcohol addiction or dependency, or current substance use or abuse.
• People who have received any other experimental treatment within 1 year before the first dose (COVID-19 vaccines are excepted).
• People with any other laboratory abnormality or medical condition that the investigator believes would pose a safety risk or prevent completion of the study.
• People who are unable to understand or sign an informed consent form.
• People who are unlikely to complete the study or follow study procedures.
• People with a known active or chronic hepatitis B, hepatitis C, or HIV infection.
• People who have had a systemic infection requiring antibiotic, antiviral, or antifungal treatment within 30 days before the first dose.
• Female participants who plan to donate eggs or undergo IVF during the study or within 6 months after the last dose.
• Male participants who plan to donate sperm during the study or within 6 months after the last dose.

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