NCT05824156

CM-101 in NASH Patients - The SPLASH Study

Phase 2A Multi-Center, Double-Blind, Randomized, Placebo-Controlled Study of CM-101 in Patients With Non-Alcoholic Steatohepatitis (NASH)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 23 (actual)
• Sponsor: ChemomAb Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
BIOLOGICAL	5 mg/kg CM-101	CM-101, Monoclonal Ab blocking CCL24
OTHER	Placebo	Placebo

Timeline

• Start date: 2021-02-24
• Primary completion: 2022-08-15
• Completion: 2022-08-25
• First posted: 2023-04-21
• Last updated: 2023-04-21

Locations

9 sites across 1 country: Israel