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NCT06655155PHASE2Recruiting

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

argenx

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

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

Interventions

COMBINATION_PRODUCT

Efgartigimod PH20 SC

OTHER

Placebo PH20 SC

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Conditions

Systemic Sclerosis (SSc)

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