A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis (eSScape)
April 22, 2026 updated by: argenx
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
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
81
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Sabine Coppieters, MD
- Phone Number: 857-350-4834
- Email: clinicaltrials@argenx.com
Study Locations
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Buenos Aires, Argentina, C1405BFN
- Recruiting
- Instituto de Investigación Clínica TyT
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Contact:
- Natalia Tamborenea, MD
- Phone Number: +548888888888
- Email: nataliatamborenea@hotmail.com
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Buenos Aires, Argentina, C1046AAQ
- Recruiting
- APRILLUS Asistencia e Investigacion
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Contact:
- Pablo Mannucci Walter, MD
- Phone Number: +54 9 11 6741-5099
- Email: walter_mannucci@yahoo.com.ar
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Buenos Aires, Argentina, C1426ABP
- Recruiting
- Consultorios Medicos Dr. Doreski - Fundacion Respirar
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Contact:
- Alejandro Arroyo, MD
- Phone Number: +54 11 6706 3598
- Email: alejandritoarroyo@yahoo.com.ar
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Buenos Aires, Argentina
- Recruiting
- Hospital General de Agudos Dr. José María Ramos Mejia
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Contact:
- Sandra Fabiana Montoya, MD
- Phone Number: +54 91163300638
- Email: sfabianamontoya@gmail.com
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Córdoba, Argentina, 5000
- Recruiting
- Sanatorio Allende S.A.
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Contact:
- Mariano Gottero, MD
- Phone Number: +543514269200
- Email: marianogottero@yahoo.com.ar
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San Miguel de Tucumán, Argentina, T4000IHE
- Recruiting
- Clínica Mayo de U.M.C.B. S.R.L
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Contact:
- Francisco Colombres, MD
- Phone Number: +54 3814502600
- Email: colombresfrancisco@yahoo.com.ar
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San Miguel de Tucumán, Argentina, T4000IKJ
- Recruiting
- Centro de Investigaciones Medicas Tucuman
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Contact:
- Horacio Berman, MD
- Phone Number: +54 9 381 5730042
- Email: cimet.2026@gmail.com
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Contact:
- Phone Number: +54 9 0381 4202226/4200180
- Email: julipuparelli@yahoo.com
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Ghent, Belgium, 9000
- Recruiting
- UZ Gent
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Contact:
- Vanessa Smith, MD
- Phone Number: +3293322856
- Email: vanessa.smith@ugent.com
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Jette, Belgium, 1090
- Recruiting
- UZ Brussel
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Contact:
- Karin Melsens, MD
- Phone Number: +3224777712
- Email: karin.melsens@uzbrussel.be
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Plovdiv, Bulgaria, 4002
- Recruiting
- Medical Center Artmed OOD
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Contact:
- Mariela Geneva-Popova, MD
- Phone Number: +359898523128
- Email: dr.mariela.geneva@gmail.com
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Sofia, Bulgaria, 1680
- Recruiting
- Diagnostic Consultative Center Convex EOOD
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Contact:
- Vladimira Boyadzhieva, MD
- Phone Number: +359884919077
- Email: vladimira.boyadzhieva@gmail.com
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Santiago, Chile, 8330034
- Recruiting
- Centro de Investigaciones Clinicas UC (CICUC)
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Contact:
- Antonia Valenzuela Vergara, MD
- Phone Number: +56226965804
- Email: contacto@cecim.cl
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Santiago, Chile, 8320000
- Recruiting
- BIOCINETIC Ltda
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Contact:
- Maria Ines Dominguez, MD
- Phone Number: +56 9 5219 8000
- Email: equipocentral.cicuc@uc.cl
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Temuco, Chile, 4810345
- Recruiting
- Centro de especialidades médicas Vanguardia
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Contact:
- Carlos Alberto Baumert Llanos, MD
- Phone Number: +56 9 9811 7209
- Email: baumert.phoenix@gmail.com
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Osijek, Croatia, 31000
- Recruiting
- Clinical Hospital Centre Osijek
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Contact:
- Jasminka Milas-Ahic, MD
- Phone Number: +38531511743
- Email: milas-ahic.jasminka@kbco.hr
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Split, Croatia, 21000
- Recruiting
- University Hospital of Split
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Contact:
- Mislav Radic, MD
- Phone Number: +38521557449
- Email: mradic@kbsplit.hr
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Zadar, Croatia, 23000
- Recruiting
- General Hospital Zadar
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Contact:
- Kristina Frketic Marovic, MD
- Phone Number: +38523505302
- Email: kristina.frketic.marovic@bolnica-zadar.hr
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Prague, Czechia, 140 59
- Recruiting
- Revmatologicky ustav
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Contact:
- Michal Tomcik, MD
- Phone Number: +420234075101
- Email: tomcik@revma.cz
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Copenhagen, Denmark, 2100
- Recruiting
- Rigshospitalet
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Contact:
- Søren Jacobsen, MD
- Phone Number: +4535450545
- Email: Soeren.Jacobsen.01@regionh.dk
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Bordeaux, France, 33000
- Recruiting
- CHU de Bordeaux - Hôpital Pellegrin
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Contact:
- Marie-Elise Truchetet, MD
- Phone Number: +33556794919
- Email: marie-elise.truchetet@chu-bordeaux.fr
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Lille, France, 59000
- Recruiting
- CHU de LILLE - Hopital Claude Huriez
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Contact:
- Vincent Sobanski, MD
- Phone Number: +33320445048
- Email: vincent.sobanski@chru-lille.fr
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Marseille, France, 13274
- Recruiting
- CHU de Strasbourg - Hôpital de Hautepierre
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Contact:
- Emmanuel Chatelus, MD
- Phone Number: +33388128115
- Email: emmanuel.chatelus@chru-strasbourg.fr
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Montpellier, France, 34090
- Recruiting
- CHU de Montpellier- Hôpital Saint Eloi
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Contact:
- Christian Jorgensen, MD
- Phone Number: +33467330190
- Email: c-jorgensen@chu-montpellier.fr
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Paris, France, 75014
- Recruiting
- AP-HP - Hôpital Cochin - Port-Royal, site Cochin
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Contact:
- Yannick Allanore, MD
- Phone Number: +33158414141
- Email: Yannick.allanore@aphp.fr
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Lübeck, Germany, 23562
- Recruiting
- Universitätsklinikum Schleswig-Holstein - Campus Lübeck
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Contact:
- Gabriela Riemekasten, MD
- Phone Number: +4945150045201
- Email: gabriela.riemekasten@uksh.de
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Minden, Germany, 32429
- Recruiting
- Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
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Contact:
- Gunter Aßmann, MD
- Phone Number: +495717903831
- Email: Rheumatologie-minden@muehlenkreiskliniken.de
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Tübingen, Germany, 72076
- Recruiting
- Universitatsklinikum Tubingen
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Contact:
- Jörg Henes, MD
- Phone Number: +4970712980681
- Email: oerg.henes@med.uni-tuebingen.de
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Pátrai, Greece, 265 04
- Recruiting
- University General Hospital of Patras
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Contact:
- Dimitrios Daousis, MD
- Phone Number: +306972828004
- Email: jimdaoussis@hotmail.com
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Pátrai, Greece, 264 43
- Recruiting
- Olympion General Clinic
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Contact:
- Andreas Bounas, MD
- Phone Number: +306944349893
- Email: andbounas@gmail.com
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Thessaloniki, Greece, 546 36
- Recruiting
- Euromedica Kianous Stavros
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Contact:
- Loukas Settas, MD
- Phone Number: +306937108727
- Email: loukassettas@gmail.com
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Pécs, Hungary, 7632
- Recruiting
- Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
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Contact:
- Gabor Kumanovics, MD
- Phone Number: +36305806138
- Email: kumanovics.gabor@pte.hu
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Florence, Italy, 50134
- Recruiting
- Azienda Ospedaliera Universitaria Careggi
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Contact:
- Silvia Bellando Randone, MD
- Phone Number: +390557946457
- Email: silvia.bellandorandone@unifi.it
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Milan, Italy, 20132
- Recruiting
- Ospedale San Raffaele S.r.l.
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Contact:
- Marco Matucci Cerinic, MD
- Phone Number: +390226433828
- Email: matuccicerinic.marco@hsr.it
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Naples, Italy, 80131
- Recruiting
- Azienda Ospedaliera Universitaria Luigi Vanvitelli
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Contact:
- Giovanna Cuomo, MD
- Phone Number: +393356638143
- Email: giovanna.cuomo@unicampania.it
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Roma, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario A. Gemelli IRCCS
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Contact:
- Maria Antonietta D'Agostino, MD
- Phone Number: +39063503654
- Email: mariaantonietta.dagostino@policlinicogemelli.it
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Roma, Italy, 128
- Recruiting
- Fondazione Policlinico Universitario Campus Bio-Medico
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Contact:
- Roberto Giacomelli, MD
- Phone Number: +3906225411980
- Email: r.giacomelli@policlinicocampus.it
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Rozzano, Italy, 20089
- Recruiting
- IRCCS Istituto Clinico Humanitas
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Contact:
- Maria De Santis, MD
- Phone Number: +390282247486
- Email: maria.de_santis@hunimed.eu
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Kaunas, Lithuania, 50161
- Recruiting
- Hospital of Lithuanian University of Health Sciences Kauno klinikos
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Contact:
- Asta Baranauskaite, MD
- Phone Number: +37068752592
- Email: asta.baranauskaite@kaunoklinikos.lt
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Klaipėda, Lithuania, LT-92288
- Recruiting
- Klaipeda Hospital, Affiliate of Klaipeda University Hospital
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Contact:
- Loreta Bukauskiene, MD
- Phone Number: +37068684485
- Email: l.bukauskiene@kul.lt
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Chihuahua City, Mexico, 31203
- Recruiting
- Mediadvance Clinical S.A.P.I. de C.V.
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Contact:
- Adelfia Urenda-Quezada, MD
- Phone Number: +52 614 674 0705
- Email: contacto@mediadvanceclinical.com
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Guadalajara, Mexico, 44160
- Recruiting
- Centro Integral Reumatologia SA de CV
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Contact:
- Hilario Avila Armengol, MD
- Phone Number: +52 33 1022 4344
- Email: cirsa.coordinadora@gmail.com
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Mexico City, Mexico, 11850
- Recruiting
- Centro de Investigación y Tratamiento Reumatológico S.C
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Contact:
- Fedra Irazoque-Palazuelos, MD
- Phone Number: +525526143031
- Email: fedraira@prodigy.net.mx
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Mérida, Mexico, 97070
- Recruiting
- Medical Care and Research S.A. de C.V.
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Contact:
- Aaron Alejandro Barrera Rodriguez, MD
- Phone Number: +529999203879
- Email: aaronbarrera@medicalcare.mx
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Leiden, Netherlands, 2333 ZA
- Recruiting
- Leids Universitair Medisch Centrum
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Contact:
- Jeska de Vries-Bouwstra, MD
- Phone Number: +31715263423
- Email: j.k.de_vries-bouwstra@lumc.nl
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Krakow, Poland, 30-002
- Recruiting
- Malopolskie Badania Kliniczne
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Contact:
- Bogdan Batko, MD
- Phone Number: +48665766366
- Email: bpbatko@gmail.com
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Lublin, Poland, 20-607
- Recruiting
- Zespol Poradni Specjalistycznych REUMED
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Contact:
- Robert Zwolak, MD
- Phone Number: +48815243333
- Email: zwolakr@wp.pl
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Nowa Sól, Poland, 67-100
- Recruiting
- Twoja Przychodnia NCM
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Contact:
- Malgorzata Miakisz, MD
- Phone Number: +48221501730
- Email: miakisz@twojaprzychodnia.com
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Warsaw, Poland, 00-874
- Recruiting
- MICS Centrum Medyczne Warszawa
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Contact:
- Katarzyna Romanowska-Prochnicka, MD
- Phone Number: +48226291354
- Email: kontakt@medycynakliniczna.pl
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Wroclaw, Poland, 53-224
- Recruiting
- Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
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Contact:
- Piotr Wiland, MD
- Phone Number: +48713647961
- Email: pwiland1@gmail.com
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Lisbon, Portugal, 1349-019
- Recruiting
- ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
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Contact:
- Manuela Costa, MD
- Phone Number: +351210431000
- Email: mmcosta@ulslo.min-saude.pt
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Lisbon, Portugal, 1649-035
- Recruiting
- ULS de Santa Maria,EPE - Hospital de Santa Maria
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Contact:
- Catarina Resende, MD
- Phone Number: +351217805000
- Email: catarinalopesresende@gmail.com
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Vila Nova de Gaia, Portugal, 4434-502
- Recruiting
- ULS de Gaia/Espinho, EPE - Unidade I
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Contact:
- Tiago Meirinhos, MD
- Phone Number: +351227865100
- Email: tiago.meirinhos@ulsge.min-saude.pt
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San Juan, Puerto Rico, 00936
- Recruiting
- The Alliance Medical Sciences Campus
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Contact:
- Grissel Rios Sola, MD
- Phone Number: 221 1-787-759-0306
- Email: pura.fuste@upr.edu
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Bucharest, Romania, 20475
- Recruiting
- Dr I Cantacuzino Clinical Hospital
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Contact:
- Ana Maria Gheorghiu, MD
- Phone Number: +40723312704
- Email: ana.gherghe@gmail.com
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Bucharest, Romania, 11172
- Recruiting
- Sf.Maria Clinical Hospital
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Contact:
- Florian Berghea, MD
- Phone Number: +40723236258
- Email: berghea1@gmail.com
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Belgrade, Serbia, 11000
- Recruiting
- Institute of Rheumatology - PPDS
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Contact:
- Maja Zlatanovic, MD
- Phone Number: +381113600801
- Email: clinicaltrials.rheumatology@gmail.com
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Belgrade, Serbia, 11152
- Recruiting
- Military Medical Academy
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Contact:
- Milan Petronijevic, MD
- Phone Number: +381113609276
- Email: milanpetronijevic@yahoo.com
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Barcelona, Spain, 8023
- Recruiting
- Hospital Del Mar
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Contact:
- Ana Pros Simon, MD
- Phone Number: +34932483000
- Email: apros@parcdesalutmar.cat
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Córdoba, Spain, 14004
- Recruiting
- C.H. Regional Reina Sofia
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Contact:
- Rafaela Ortega Castro, MD
- Phone Number: +34957011631
- Email: orcam84@hotmail.com
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Sabadell, Spain, 08208
- Recruiting
- Corporacio Sanitaria Parc Tauli
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Contact:
- Joan Calvet Fontova, MD
- Phone Number: +34937231010
- Email: calvet.parctauli@gmail.com
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Sankt Gallen, Switzerland, 9000
- Recruiting
- Kantonsspital St. Gallen
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Contact:
- Frauke Förger, MD
- Phone Number: +41 71 494 27 28
- Email: Studien.Rheumatologie@h-och.ch
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Zurich, Switzerland, 8090
- Recruiting
- Universitatsspital Zurich
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Contact:
- Muriel Elhai, MD
- Phone Number: +41 43 253 69 94
- Email: eva-maria.deschauer@usz.ch
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Leeds, United Kingdom, LS7 4SA
- Recruiting
- Chapel Allerton Hospital
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Contact:
- Francesco Del Galdo, MD
- Phone Number: 0113 3924331
- Email: sumit.lahiri@nhs.net
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London, United Kingdom, NW3 2QG
- Recruiting
- Royal Free Hospital
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Contact:
- Voon Ong, MD
- Phone Number: 02073177544
- Email: rf-tr.rheumclinicaltrials@nhs.net
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Luton, United Kingdom, LU4 0DZ
- Recruiting
- Luton and Dunstable University Hospital
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Contact:
- Muhammad Nisar, MD
- Phone Number: +01234355122
- Email: rheumatology.research@bedsft.nhs.uk
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Arizona
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Phoenix, Arizona, United States, 85032-9306
- Recruiting
- Arizona Arthritis and Rheumatology Associates
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Contact:
- Saima Chohan, MD
- Phone Number: 137 480-626-6637
- Email: mandee.lochridge@aaracr.com
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California
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Los Angeles, California, United States, 90095
- Recruiting
- UCLA Ronald Reagan University of California Los Angeles Medical Center
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Contact:
- Suzanne Kafaja, MD
- Phone Number: 310-825-9682
- Email: lnam@mednet.ucla.edu
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Florida
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Plantation, Florida, United States, 33324
- Recruiting
- IRIS Research and Development LLC
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Contact:
- Guillermo Valenzuela, MD
- Phone Number: 109 954-476-2338
- Email: jgalindo@irisrheumatology.com
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Illinois
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Chicago, Illinois, United States, 60612
- Recruiting
- University of Illinois Health Outpatient Care Center
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Contact:
- Nadera Sweiss, MD
- Phone Number: 312-355-6167
- Email: nsweiss@uic.edu
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Louisiana
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New Orleans, Louisiana, United States, 70112
- Recruiting
- DelRicht Research, LLC
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Contact:
- Lesley Saketkoo, MD
- Phone Number: 504-336-2667
- Email: no_recruitment@delricht.com
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Maryland
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Baltimore, Maryland, United States, 21224
- Recruiting
- Johns Hopkins Asthma and Allergy Center
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Contact:
- Ami Shah, MD
- Phone Number: 410-550-8582
- Email: gleathe1@jh.edu
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Columbia, Maryland, United States, 21044
- Recruiting
- Thomas Jefferson University
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Contact:
- Fabian Mendoza-Ballesteros, MD
- Phone Number: 215-955-3823
- Email: atmroseline.atchori@jefferson.edu
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Michigan
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Ann Arbor, Michigan, United States, 48109
- Recruiting
- University of Michigan Hospital
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Contact:
- Erica Mulcaire-Jones, MD
- Phone Number: 888-229-3065
- Email: ericajaf@med.umich.edu
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19104
- Recruiting
- Perelman Center for Advanced Medicine
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Contact:
- Nora Sandorfi, MD
- Phone Number: 215-614-4407
- Email: lauren.baker@pennmedicine.upenn.edu
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC
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Subcutaneous efgartigimod PH20 SC given by prefilled syringe
|
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Placebo Comparator: Placebo PH20 SC
Participants receiving placebo PH20 SC
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Subcutaneous placebo PH20 SC given by prefilled syringe
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in mRSS at week 24
Time Frame: Up to 24 weeks
|
The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body.
Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe).
The total score is the sum of the individual skin scores and can range from 0 to 51.
|
Up to 24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline in mRSS at week 48
Time Frame: Up to 48 weeks
|
The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body.
Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe).
The total score is the sum of the individual skin scores and can range from 0 to 51.
|
Up to 48 weeks
|
|
Incidence of treatment-emergent (serious) adverse events
Time Frame: Up to 55 weeks
|
Up to 55 weeks
|
|
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Proportion of participants who improve in at least 2 or at least 3 of the 5 core items of CRISS-25 at weeks 24 and 48 and do not have worsening in >1 component and have no significant SSc-related event(s)
Time Frame: Up to 48 weeks
|
Revised Composite Response Index in Systemic Sclerosis (CRISS-25) is a global composite outcome assessment that provides a holistic perspective of the disease.
It includes 5 core items: the Modified Rodnan Skin Score, the Clinician's global assessment, the Forced Vital Capacity, the Patient global assessment, and the Health Assessment Questionnaire-Disability Index.
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Up to 48 weeks
|
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Change from baseline in HAQ-DI at weeks 24 and 48
Time Frame: Up to 48 weeks
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Health Assessment Questionnaire-Disability Index is a tool to assess physical function and disability.
It consists of 8 categories with each question scored from 0 (without any difficulty) to 3 (unable to do).
|
Up to 48 weeks
|
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Change from baseline in PGA at weeks 24 and 48
Time Frame: Up to 48 weeks
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Patient's Global Assessment is a tool that measures a participant's global evaluation of their overall health during the previous week using a 10-point numerical scale.
The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).
|
Up to 48 weeks
|
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Change from baseline in CGA at weeks 24 and 48
Time Frame: Up to 48 weeks
|
Clinician's Global Assessment is a tool that measures a clinician's assessment of the overall health of a participant during the previous week using a 10-point numerical scale.
The score varies between 0 (excellent overall health) and 10 (extremely poor overall health).
|
Up to 48 weeks
|
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Annualized rate of decline in FVC (in mL) in participants with interstitial lung disease
Time Frame: Up to 48 weeks
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Forced Vital Capacity is a tool to assess lung function
|
Up to 48 weeks
|
|
Efgartigimod serum concentrations over time
Time Frame: Up to 48 weeks
|
Up to 48 weeks
|
|
|
Percent change from baseline in total IgG levels in serum over time
Time Frame: Up to 55 weeks
|
Up to 55 weeks
|
|
|
Incidence of anti-drug antibodies against efgartigimod in serum over time
Time Frame: Up to 55 weeks
|
Up to 55 weeks
|
|
|
Incidence of antibodies against rHuPH20 in plasma over time
Time Frame: Up to 55 weeks
|
Up to 55 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 11, 2024
Primary Completion (Estimated)
February 1, 2027
Study Completion (Estimated)
September 1, 2027
Study Registration Dates
First Submitted
October 22, 2024
First Submitted That Met QC Criteria
October 22, 2024
First Posted (Actual)
October 23, 2024
Study Record Updates
Last Update Posted (Actual)
April 23, 2026
Last Update Submitted That Met QC Criteria
April 22, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ARGX-113-2317
- 2024-514539-67-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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