Evaluating the effects of efgartigimod PH20 SC in adults with systemic sclerosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study aims to assess the efficacy and safety of efgartigimod PH20 SC in adults diagnosed with systemic sclerosis (SSc). Participants will undergo a screening period followed by a treatment phase lasting up to 48 weeks, where they will be randomly assigned to receive either the active drug or a placebo. The study will also include a safety follow-up period, making the total duration approximately 15 months. The primary focus is on measuring the drug's impact on symptoms and overall health in individuals with SSc.

Why it matters

Who can join: the full rules

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

Where it's running

• Arizona Arthritis and Rheumatology Associates
  Phoenix, Arizona, United States Recruiting
• UCLA Ronald Reagan University of California Los Angeles Medical Center
  Los Angeles, California, United States Recruiting
• IRIS Research and Development LLC
  Plantation, Florida, United States Recruiting
• University of Illinois Health Outpatient Care Center
  Chicago, Illinois, United States Recruiting
• DelRicht Research, LLC
  New Orleans, Louisiana, United States Recruiting
• Johns Hopkins Asthma and Allergy Center
  Baltimore, Maryland, United States Recruiting

+24 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Sabine Coppieters, MD
• Email: clinicaltrials@argenx.com
• Phone: 857-350-4834

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.