NCT06655155

A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis

A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 81 (estimated)
• Sponsor: argenx · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis. The study consists of a screening period, a treatment period of up to 48 weeks and a safety follow-up period. After the screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod PH20 SC or placebo. The total study duration can be up to approximately 15 months. More information can be found on: https://clinicaltrials.argenx.com/esscape

Conditions

• Systemic Sclerosis (SSc)

Interventions

Type	Name	Description
COMBINATION_PRODUCT	Efgartigimod PH20 SC	Subcutaneous efgartigimod PH20 SC given by prefilled syringe
OTHER	Placebo PH20 SC	Subcutaneous placebo PH20 SC given by prefilled syringe

Timeline

• Start date: 2024-11-11
• Primary completion: 2026-08-17
• Completion: 2027-06-14
• First posted: 2024-10-23
• Last updated: 2026-03-11

Locations

69 sites across 23 countries: United States, Argentina, Belgium, Bulgaria, Chile, Croatia, Czechia, Denmark, France, Germany, Greece, Hungary, Italy, Lithuania, Netherlands, Poland, Portugal, Puerto Rico, Romania, Serbia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study