A Phase 2 Study to Evaluate the Safety and Effectiveness of Efgartigimod PH20 Given by Injection in Adults With Systemic Sclerosis

What this Trial Is About

Researchers are evaluating the effect and safety of efgartigimod PH20 SC compared to placebo in adults with systemic sclerosis, a chronic autoimmune disease. This phase 2, randomized, double-blinded, placebo-controlled study aims to assess how well the treatment works and its safety profile. Participants have systemic sclerosis with specific skin involvement and meet classification criteria, with the study sponsored by argenx. Eligible participants will be randomly assigned in a 21 ratio to receive either subcutaneous efgartigimod PH20 SC or a placebo, both given by prefilled syringe. The treatment period lasts up to 48 weeks, followed by a safety follow-up period. The total duration of the study can be up to approximately 15 months, including screening, treatment, and follow-up. Participants will undergo screening to confirm eligibility and then receive regular doses of the study drug or placebo during the treatment phase. Assessments include changes in skin thickness measured by the modified Rodnan Skin Score mRSS at 24 and 48 weeks, safety monitoring for adverse events, and evaluations of disability, patient and clinician assessments, lung function, and antibody levels. The study also tracks pharmacokinetics, immunogenicity, and antibody responses throughout the treatment and follow-up periods.

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