Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis
brief summary
This study is designed to assess the safety and tolerability of the anti-human CCL24 monoclonal antibody CM-101 in adult patients with systemic sclerosis (SSc). Approximately 45 patients at approximately 40 sites will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo.
detailed description
This study will consist of a screening period, double-blind treatment period, open-label treatment period, and safety follow-up. Approximately 45 patients will be randomized in a 2:1 ratio to receive either 10 mg/kg CM-101 or placebo. The study drug or placebo, will be administered as a 60-minute intravenous (IV) infusion once every 3 weeks for a treatment coverage of 24 weeks.
official title
A Phase 2, Multicenter, Randomized, Double-Blind, Proof of Biology Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis