A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Start Date
11/11/2024
Completion Date
9/1/2027
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Efgartigimod PH20 SC
Placebo PH20 SC
Conditions
Locations
Arizona Arthritis and Rheumatology Associates
Phoenix, Arizona 85032-9306
United States
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California 90095
United States
IRIS Research and Development LLC
Plantation, Florida 33324
United States
University of Illinois Health Outpatient Care Center
Chicago, Illinois 60612
United States
DelRicht Research, LLC
New Orleans, Louisiana 70112
United States
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland 21224
United States
Thomas Jefferson University
Columbia, Maryland 21044
United States
University of Michigan Hospital
Ann Arbor, Michigan 48109
United States
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
United States
Aprillus Asistencia e Investigacion
Buenos Aires, C1046AAQ
Argentina
Instituto de Investigación Clínica TyT
Buenos Aires, C1405BFN
Argentina
Consultorios Médicos Dr. Doreski - Fundacion Respirar
Buenos Aires, C1426ABP
Argentina
Hospital General de Agudos Dr. José María Ramos Mejia
Buenos Aires,
Argentina
Sanatorio Allende S.A.
Córdoba, 5000
Argentina
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, T4000IAP
Argentina
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, T4000IHE
Argentina
Centro de Investigaciones Médicas Tucumán
San Miguel de Tucumán, T4000IKJ
Argentina
UZ Gent
Ghent, 9000
Belgium
UZ Brussel
Jette, 1090
Belgium
Medical Center Artmed OOD
Plovdiv, 4002
Bulgaria
Diagnostic Consultative Center Convex EOOD
Sofia, 1680
Bulgaria
BIOCINETIC Ltda
Santiago, 8320000
Chile
Centro de Investigaciones Clinicas UC (CICUC)
Santiago, 8330034
Chile
Centro de especialidades médicas Vanguardia
Temuco, 4810345
Chile
Clinical Hospital Centre Osijek
Osijek, 31000
Croatia
University Hospital of Split
Split, 21000
Croatia
General Hospital Zadar
Zadar, 23000
Croatia
Revmatologicky Ustav
Prague, 140 59
Czechia
Rigshospitalet
Copenhagen, 2100
Denmark
CHU de Bordeaux - Hôpital Pellegrin
Bordeaux, 33000
France
CHU de Lille - Hopital Claude Huriez
Lille, 59000
France
CHU de Strasbourg - Hôpital de Hautepierre
Marseille, 13274
France
CHU de Montpellier- Hôpital Saint Eloi
Montpellier, 34090
France
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
Paris, 75014
France
Auenlandklinik Bad Bramstedt GmbH
Bad Bramstedt, 24576
Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
Lübeck, 23562
Germany
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
Minden, 32429
Germany
Universitätsklinikum Tübingen
Tübingen, 72076
Germany
Olympion General Clinic
Pátrai, 264 43
Greece
University General Hospital of Patras
Pátrai, 265 04
Greece
Euromedica Kianous Stavros
Thessaloniki, 546 36
Greece
Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
Pécs, 7632
Hungary
Azienda Ospedaliera Universitaria Careggi
Florence, 50134
Italy
Ospedale San Raffaele S.r.l.
Milan, 20132
Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli
Naples, 80131
Italy
Fondazione Policlinico Universitario A. Gemelli IRCCS
Roma, 00168
Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 128
Italy
IRCCS Istituto Clinico Humanitas
Rozzano, 20089
Italy
Hospital of Lithuanian University of Health Sciences Kauno klinikos
Kaunas, 50161
Lithuania
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
Klaipėda, LT-92288
Lithuania
Mediadvance Clinical S.A.P.I. de C.V.
Chihuahua City, 31203
Mexico
Centro Integral Reumatologia SA de CV
Guadalajara, 44160
Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
Mexico City, 11850
Mexico
Medical Care and Research S.A. de C.V.
Mérida, 97070
Mexico
Leids Universitair Medisch Centrum
Leiden, 2333 ZA
Netherlands
Malopolskie Badania Kliniczne
Krakow, 30-002
Poland
Zespol Poradni Specjalistycznych REUMED
Lublin, 20-607
Poland
Twoja Przychodnia NCM
Nowa Sól, 67-100
Poland
MICS Centrum Medyczne Warszawa
Warsaw, 00-874
Poland
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
Wroclaw, 53-224
Poland
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
Lisbon, 1349-019
Portugal
ULS de Santa Maria,EPE - Hospital de Santa Maria
Lisbon, 1649-035
Portugal
ULS de Gaia/Espinho, EPE - Unidade I
Vila Nova de Gaia, 4434-502
Portugal
The Alliance Medical Sciences Campus
San Juan, 00936
Puerto Rico
Sf.Maria Clinical Hospital
Bucharest, 11172
Romania
Dr I Cantacuzino Clinical Hospital
Bucharest, 20475
Romania
Institute of Rheumatology - PPDS
Belgrade, 11000
Serbia
Military Medical Academy
Belgrade, 11152
Serbia
Hospital Del Mar
Barcelona, 8023
Spain
C.H. Regional Reina Sofia
Córdoba, 14004
Spain
Corporacio Sanitaria Parc Tauli
Sabadell, 08208
Spain
Kantonsspital St. Gallen
Sankt Gallen, 9000
Switzerland
Universitätsspital Zürich
Zurich, 8090
Switzerland
Chapel Allerton Hospital
Leeds, LS7 4SA
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
Luton and Dunstable University Hospital
Luton, LU4 0DZ
United Kingdom