LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)

Launched by LIVEOME INC. · Dec 23, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called LIV001 for people who have mild to moderate ulcerative colitis (UC), a condition that causes inflammation in the lining of the intestines. The main goal of this trial is to see if LIV001 is safe to use and how well it can be tolerated by patients. The study is currently not recruiting participants, but it will include adults aged 18 to 65 who have been diagnosed with UC for at least three months.

To participate in the trial, individuals must not have other types of inflammatory bowel diseases, like Crohn's disease, or conditions that weaken the immune system. Participants can expect to undergo a screening process that includes confirming their UC diagnosis through medical records or a letter from their doctor. Throughout the trial, they will receive close monitoring to ensure their safety while taking LIV001. This study is an important step in finding new treatment options for people living with ulcerative colitis.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Male or female aged 18 to 65 years (inclusive) at Screening.
• • 2. Established diagnosis of UC for at least 3 months prior to Screening, diagnosed by routine clinical, radiographic, endoscopic or pathologic criteria (Confirmed by colonoscopy and pathology records or, if unavailable, diagnosis confirmed by a letter from the subject's general practitioner.)
• Exclusion Criteria:
• • 1. Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
• • 2. History of a condition associated with significant immunosuppression, or chronic administration (\> 14 consecutive days) of immunosuppressants or other immune-modifying drugs within 3 months prior to Visit 3 (subjects taking oral medications for UC, including corticosteroids or immunomodulators, are not excluded).