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

March 21, 2025 updated by: Liveome Inc.

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

A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Poland
      • Wroclaw, Poland
        • Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: LIV001
LIV001 will be given orally and daily from baseline until end of study
Drug: LIV001
Orally administered for 8 weeks
Placebo Comparator: Placebo
Placebo will be given orally and daily from baseline until end of study
Drug: Placebo
Orally administered for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of subjects with adverse events (AEs)
Time Frame: Baseline through Study Completion (Week 12).
Baseline through Study Completion (Week 12).
Number of subjects with clinical laboratory abnormalities
Time Frame: Baseline through Study Completion (Week 12).
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).
Baseline through Study Completion (Week 12).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Liveome Inc.

Investigators

  • Principal Investigator: Piotr Napora, Doctor of Medicine, Centrum Badan Klinicznych Piotr Napora lekarze spolka partnerska

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 24, 2025

Primary Completion (Estimated)

January 17, 2026

Study Completion (Estimated)

March 24, 2026

Study Registration Dates

First Submitted

December 17, 2024

First Submitted That Met QC Criteria

December 23, 2024

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 21, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LIV001-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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