Ulcerative Colitis (UC)
Conditions
Brief summary
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
Detailed description
A randomized, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of LIV001 in patients with mild to moderate UC. Patients will receive LIV001 or placebo for 8 weeks. All patients will return to the site for a follow-up visit on week 12.
Interventions
DRUGLIV001
Orally administered for 8 weeks
DRUGPlacebo
Orally administered for 8 weeks
Sponsors
Liveome Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Number of subjects with adverse events (AEs) | Baseline through Study Completion (Week 12). |
| Number of subjects with clinical laboratory abnormalities | Baseline through Study Completion (Week 12). |
| Number of subjects with changes in the 12-lead electrocardiogram (ECG) | Baseline through Study Completion (Week 12). |
Countries
Poland
Contacts
Primary ContactSophie Hyun-Ja Ko, Doctor of Philosophy
Outcome results
None listed