CM-101 in NASH Patients - The SPLASH Study

Status Completed

Clinical Trial Summary

This phase 2a study is a multi-center, double-blind randomized, placebo-controlled study. The study is designed to determine the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with non-cirrhotic nonalcoholic steatohepatitis (NASH) patients with stage 1c, 2 or 3 fibrosis. The patients will be randomized to 1 of 2 treatment groups: 5 mg/kg CM-101 or placebo.

Clinical Trial Description

This study will consist of screening period, treatment period and follow-up period. Adults with NASH will be included. Each subject will undergo screening procedures within up to 42 days prior to Randomization, to assess eligibility to participate in the study. After randomization patients will receive a dose of investigational product once every 2 weeks for a total of 8 administrations. This will result in a total coverage of 16 weeks. Study participation will last for up to approximately 26 weeks (up to 6 weeks for screening followed by 14 weeks treatment and 6 weeks follow-up). ;

Study Design

Related Conditions & MeSH terms

Fatty Liver
Non-alcoholic Fatty Liver Disease
Nonalcoholic Steatohepatitis

Clinical Trial Details

NCT number	NCT05824156
Study type	Interventional
Source	ChemomAb Ltd.
Contact
Status	Completed
Phase	Phase 2
Start date	February 24, 2021
Completion date	August 25, 2022

View Details

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