drugset
drugset / Trial / NCT04595825

CM-101 in PSC Patients -The SPRING Study

NCT04595825 ↗

Phase 2 Completed 77 enrolled ChemomAb Ltd.
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is designed to assess the safety, tolerability and activity of the anti-human CCL24 monoclonal antibody CM-101 in adult subjects with Primary Sclerosing Cholangitis (PSC). At least 68 subjects at approximately 50 sites will be randomized to receive either CM-101 at doses of 10 mg/kg or 20 mg/kg or matching placebo.

Timeline

Start
2020-10-01
Primary completion
2025-01-10
Completion
2025-01-10

Drugs

EvaluationDrugModalityDoseRoute
Subject CM-101 Monoclonal antibody 10 mg/kg Intravenous
Subject CM-101 Monoclonal antibody 20 mg/kg Intravenous
Subject CM-101 Monoclonal antibody 100 mg Intravenous

Indications

primary sclerosing cholangitis