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

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

Eligibility

Age range

18+ years

Sex

All

Healthy volunteers

No

Interventions

• 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

Locations (74)