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
- Systemic Sclerosis (SSc)
At a glance
- Phase
- Phase 2
- Study type
- Interventional
- Sponsor
- argenx
- Enrolment target
- 81
- Started
- 11 November 2024
- Main results due
- February 2027
- Study sites
- 79
- Registry updated
- 24 September 2026
Can you take part?
- Aged 18 years and over.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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
What this study is about
In the sponsor’s own words, from the registry.
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
Study sites(79)
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
Thomas Jefferson University
Columbia, Maryland, United States
Recruiting
University of Michigan Hospital
Ann Arbor, Michigan, United States
Recruiting
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania, United States
Recruiting
Aprillus Asistencia e Investigacion
Buenos Aires, Argentina
Recruiting
Instituto de Investigación Clínica TyT
Buenos Aires, Argentina
Recruiting
Consultorios Médicos Dr. Doreski - Fundacion Respirar
Buenos Aires, Argentina
Recruiting
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires, Argentina
Recruiting
Sanatorio Allende S.A.
Córdoba, Argentina
Recruiting
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Argentina
Recruiting
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Argentina
Recruiting
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, Argentina
Recruiting
UZ Gent
Ghent, Belgium
Recruiting
UZ Brussel
Jette, Belgium
Recruiting
Medical Center Artmed OOD
Plovdiv, Bulgaria
Recruiting
Diagnostic Consultative Center Convex EOOD
Sofia, Bulgaria
Recruiting
BIOCINETIC Ltda
Santiago, Chile
Recruiting
Centro de Investigaciones Clinicas UC (CICUC)
Santiago, Chile
Recruiting
Centro de especialidades médicas Vanguardia
Temuco, Chile
Recruiting
Clinical Hospital Centre Osijek
Osijek, Croatia
Recruiting
University Hospital of Split
Split, Croatia
Recruiting
General Hospital Zadar
Zadar, Croatia
Recruiting
Revmatologicky Ustav
Prague, Czechia
Recruiting
Rigshospitalet
Copenhagen, Denmark
Recruiting
CHU de Lille - Hopital Claude Huriez
Lille, Nord, France
Recruiting
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
Recruiting
CHU de Lille - Hopital Claude Huriez
Lille, France
Recruiting
CHU de Strasbourg - Hôpital de Hautepierre
Marseille, France
Recruiting
CHU de Montpellier- Hôpital Saint Eloi
Montpellier, France
Recruiting
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
Paris, France
Recruiting
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, Germany
Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Recruiting
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, Germany
Recruiting
Universitätsklinikum Tübingen
Tübingen, Germany
Recruiting
Olympion General Clinic
Pátrai, Greece
Recruiting
University General Hospital of Patras
Pátrai, Greece
Recruiting
Euromedica Kianous Stavros
Thessaloniki, Greece
Recruiting
Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
Pécs, Hungary
Recruiting
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Recruiting
Ospedale San Raffaele S.r.l.
Milan, Italy
Recruiting
Azienda Ospedaliero-Universitaria di Modena - Policlinico di Modena
Modena, Italy
Recruiting
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy
Recruiting
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
Recruiting
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
Recruiting
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
Klaipėda, Lithuania
Recruiting
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Belisario Domínguez, Tlalpan, Mexico
Recruiting
Mediadvance Clinical S.A.P.I. de C.V.
Chihuahua City, Mexico
Recruiting
Centro Integral Reumatologia SA de CV
Guadalajara, Mexico
Recruiting
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, Mexico
Recruiting
Medical Care and Research S.A. de C.V.
Mérida, Mexico
Recruiting
Leids Universitair Medisch Centrum
Leiden, Netherlands
Recruiting
Malopolskie Badania Kliniczne
Krakow, Poland
Recruiting
Zespol Poradni Specjalistycznych REUMED
Lublin, Poland
Recruiting
Showing 60 of 79 sites — filter to narrow it down. 79 of the 79 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06655155. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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