NCT06210945

Study to Evaluate the Safety, Tolerability, and Activity of CM-101 in Patients With Systemic Sclerosis

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

• Status: Suspended
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 45 (estimated)
• Sponsor: ChemomAb Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Systemic Sclerosis

Interventions

Type	Name	Description
DRUG	10 mg/kg CM-101	10 mg/kg CM-101
DRUG	Placebo	Placebo

Timeline

• Start date: 2026-09-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2024-01-18
• Last updated: 2026-04-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study