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

Launched by ARGENX · Oct 22, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called efgartigimod PH20 SC to see if it can help adults with systemic sclerosis (SSc), a condition that affects the skin and other parts of the body. The goal is to determine how effective and safe this treatment is compared to a placebo, which is an inactive substance that looks like the medication but doesn't contain any active ingredients. The study will last for about 15 months and includes a screening phase to see if participants qualify, followed by up to 48 weeks of treatment and a safety follow-up period.

To be eligible for the trial, participants must be at least 18 years old and diagnosed with either diffuse or limited systemic sclerosis. They should have specific test results that show their condition meets certain criteria, such as having a certain level of skin thickening and a positive antinuclear antibodies test. Participants will be randomly assigned to receive either the study medication or a placebo. Throughout the study, participants can expect regular check-ups to monitor their health and any side effects. It’s important to note that certain health conditions, like significant lung issues or certain types of antibodies, would exclude someone from participating in this trial.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Is aged ≥18 years and the local legal age of consent for clinical studies
• • Has diffuse or limited SSc diagnosis and fulfills the 2013 ACR/EULAR classification criteria
• • Has a positive antinuclear antibodies (ANA) test result at the central laboratory with titer of at least 1:160
• • Has a Health Assessment Questionnaire-Disability Index (HAQ-DI) score of at least 0.5 OR a Patient Global Assessment (PGA) score of at least 3
• • Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
• • The participant is anti-RNA polymerase III autoantibody negative at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 5 years before screening or the participant is anti-RNA polymerase III autoantibody positive at central laboratory and had the first non-Raynaud's phenomenon manifestation less than 2 years before screening
• • Has uninvolved or mildly thickened skin area in at least 1 injection site
• Exclusion Criteria:
• • Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
• • Significant Pulmonary Arterial Hypertension
• • Severe digital vasculopathy within the past 3 months
• • Skin thickening due to scleroderma mimics or localized scleroderma
• • Scleroderma renal crisis within the past 6 months of participating to the study
• • Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia