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A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Sponsor: argenx
Summary
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
Official title: 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
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
81
Start Date
2024-11-11
Completion Date
2027-06-14
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Efgartigimod PH20 SC
Subcutaneous efgartigimod PH20 SC given by prefilled syringe
Placebo PH20 SC
Subcutaneous placebo PH20 SC given by prefilled syringe
Locations (69)
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
BIOCINETIC Ltda
Santiago, Chile
Centro de Investigaciones Clinicas UC (CICUC)
Santiago, Chile
Centro de especialidades médicas Vanguardia
Temuco, Chile
Clinical Hospital Centre Osijek
Osijek, Croatia
University Hospital of Split
Split, Croatia
General Hospital Zadar
Zadar, Croatia
Revmatologicky Ustav
Prague, Czechia
Rigshospitalet
Copenhagen, Denmark
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, France
CHU de Lille - Hopital Claude Huriez
Lille, France
CHU de Strasbourg - Hôpital de Hautepierre
Marseille, France
CHU de Montpellier- Hôpital Saint Eloi
Montpellier, France
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
Paris, France
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, Germany
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, Germany
Universitätsklinikum Tübingen
Tübingen, Germany
Olympion General Clinic
Pátrai, Greece
University General Hospital of Patras
Pátrai, Greece
Euromedica Kianous Stavros
Thessaloniki, Greece
Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
Pécs, Hungary
Azienda Ospedaliera Universitaria Careggi
Florence, Italy
Ospedale San Raffaele S.r.l.
Milan, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
IRCCS Istituto Clinico Humanitas
Rozzano, Italy
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, Lithuania
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
Klaipėda, Lithuania
Leids Universitair Medisch Centrum
Leiden, Netherlands
Malopolskie Badania Kliniczne
Krakow, Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, Poland
Twoja Przychodnia NCM
Nowa Sól, Poland
MICS Centrum Medyczne Warszawa
Warsaw, Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
Wroclaw, Poland
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria
Lisbon, Portugal
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, Portugal
The Alliance Medical Sciences Campus
San Juan, Puerto Rico
Sf.Maria Clinical Hospital
Bucharest, Romania
Dr I Cantacuzino Clinical Hospital
Bucharest, Romania
Military Medical Academy
Belgrade, Serbia
Hospital Del Mar
Barcelona, Spain
C.H. Regional Reina Sofia
Córdoba, Spain
Corporacio Sanitaria Parc Tauli
Sabadell, Spain
Kantonsspital St. Gallen
Sankt Gallen, Switzerland
Universitätsspital Zürich
Zurich, Switzerland
Chapel Allerton Hospital
Leeds, United Kingdom
Royal Free Hospital
London, United Kingdom
Luton and Dunstable University Hospital
Luton, United Kingdom