drugset / Trial / NCT06655155

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

NCT06655155

Phase 2 Recruiting 81 enrolled argenx
RandomizedParallel-groupQuadruple-blindTreatment

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

Timeline

Start
2024-11-11
Primary completion
2027-02
Completion
2027-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Efgartigimod Alfa Protein / enzyme biologic Subcutaneous

Indications