LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: LIV001, Placebo.
- Who it may be relevant to
- Registry conditions: Ulcerative Colitis (UC). Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Poland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Randomized, Double-Blind, Placebo Controlled, Multi -Center, Phase 1b Study to Evaluate the Safety and Tolerability of LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis
Overview
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
- Drug LIV001
Orally administered for 8 weeks - Drug Placebo
Orally administered for 8 weeks
Primary outcome measures
- Number of subjects with adverse events (AEs) [Time frame: Baseline through Study Completion (Week 12).]
- Number of subjects with clinical laboratory abnormalities [Time frame: Baseline through Study Completion (Week 12).]
- Number of subjects with changes in the 12-lead electrocardiogram (ECG) [Time frame: Baseline through Study Completion (Week 12).]
Eligibility criteria
Inclusion criteria
- Male or female aged 18 to 65 years (inclusive) at Screening.
- 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
- Possible or confirmed diagnosis of Crohn's Disease, other form of inflammatory bowel disorder and coeliac disease.
- 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).
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Triple blind
- Primary purpose
- Treatment
Study locations
Poland · 1 center
- Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska — Wroclaw
Identifiers
NCT: NCT06749795 · LIV001-02