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RECRUITINGPhase 2INTERVENTIONAL

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

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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

Who May Be Eligible (Plain English)

Who May Qualify: - 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 Who Should NOT Join This Trial: - 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 conditions (where your immune system attacks your own body), except for secondary Sjögren's syndrome or fibromyalgia Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

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 (20)

Arizona Arthritis and Rheumatology Associates
Phoenix, Arizona, United States
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California, United States
IRIS Research and Development LLC
Plantation, Florida, United States
University of Illinois Health Outpatient Care Center
Chicago, Illinois, United States
DelRicht Research, LLC
New Orleans, Louisiana, United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland, United States
Thomas Jefferson University
Columbia, Maryland, United States
University of Michigan Hospital
Ann Arbor, Michigan, United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Aprillus Asistencia e Investigacion
Buenos Aires, Argentina
Instituto de Investigación Clínica TyT
Buenos Aires, Argentina
Consultorios Médicos Dr. Doreski - Fundacion Respirar
Buenos Aires, Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Argentina
Sanatorio Allende S.A.
Córdoba, Argentina
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Argentina
UZ Gent
Ghent, Belgium
UZ Brussel
Jette, Belgium
Medical Center Artmed OOD
Plovdiv, Bulgaria
Diagnostic Consultative Center Convex EOOD
Sofia, Bulgaria