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

NCT ID: NCT06655155

Last Updated: 2026-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-11

Study Completion Date

2027-06-14

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Sclerosis (SSc)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Efgartigimod PH20 SC

Participants receiving efgartigimod PH20 SC

Group Type EXPERIMENTAL

Efgartigimod PH20 SC

Intervention Type COMBINATION_PRODUCT

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC

Participants receiving placebo PH20 SC

Group Type PLACEBO_COMPARATOR

Placebo PH20 SC

Intervention Type OTHER

Subcutaneous placebo PH20 SC given by prefilled syringe

Interventions

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Efgartigimod PH20 SC

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Intervention Type COMBINATION_PRODUCT

Placebo PH20 SC

Subcutaneous placebo PH20 SC given by prefilled syringe

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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argenx

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Arizona Arthritis and Rheumatology Associates

Phoenix, Arizona, United States

Site Status RECRUITING

UCLA Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, United States

Site Status RECRUITING

IRIS Research and Development LLC

Plantation, Florida, United States

Site Status RECRUITING

University of Illinois Health Outpatient Care Center

Chicago, Illinois, United States

Site Status RECRUITING

DelRicht Research, LLC

New Orleans, Louisiana, United States

Site Status RECRUITING

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, United States

Site Status RECRUITING

Thomas Jefferson University

Columbia, Maryland, United States

Site Status RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, United States

Site Status RECRUITING

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Aprillus Asistencia e Investigacion

Buenos Aires, , Argentina

Site Status RECRUITING

Instituto de Investigación Clínica TyT

Buenos Aires, , Argentina

Site Status RECRUITING

Consultorios Médicos Dr. Doreski - Fundacion Respirar

Buenos Aires, , Argentina

Site Status RECRUITING

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, , Argentina

Site Status RECRUITING

Sanatorio Allende S.A.

Córdoba, , Argentina

Site Status RECRUITING

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, , Argentina

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Brussel

Jette, , Belgium

Site Status RECRUITING

Medical Center Artmed OOD

Plovdiv, , Bulgaria

Site Status RECRUITING

Diagnostic Consultative Center Convex EOOD

Sofia, , Bulgaria

Site Status RECRUITING

BIOCINETIC Ltda

Santiago, , Chile

Site Status RECRUITING

Centro de Investigaciones Clinicas UC (CICUC)

Santiago, , Chile

Site Status RECRUITING

Centro de especialidades médicas Vanguardia

Temuco, , Chile

Site Status RECRUITING

Clinical Hospital Centre Osijek

Osijek, , Croatia

Site Status RECRUITING

University Hospital of Split

Split, , Croatia

Site Status RECRUITING

General Hospital Zadar

Zadar, , Croatia

Site Status RECRUITING

Revmatologicky Ustav

Prague, , Czechia

Site Status RECRUITING

Rigshospitalet

Copenhagen, , Denmark

Site Status RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, , France

Site Status RECRUITING

CHU de Lille - Hopital Claude Huriez

Lille, , France

Site Status RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Marseille, , France

Site Status RECRUITING

CHU de Montpellier- Hôpital Saint Eloi

Montpellier, , France

Site Status RECRUITING

AP-HP - Hôpital Cochin - Port-Royal, site Cochin

Paris, , France

Site Status RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, , Germany

Site Status RECRUITING

Mühlenkreiskliniken - Johannes Wesling Klinikum Minden

Minden, , Germany

Site Status RECRUITING

Universitätsklinikum Tübingen

Tübingen, , Germany

Site Status RECRUITING

Olympion General Clinic

Pátrai, , Greece

Site Status RECRUITING

University General Hospital of Patras

Pátrai, , Greece

Site Status RECRUITING

Euromedica Kianous Stavros

Thessaloniki, , Greece

Site Status RECRUITING

Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika

Pécs, , Hungary

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, , Italy

Site Status RECRUITING

Ospedale San Raffaele S.r.l.

Milan, , Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Napoli, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, , Italy

Site Status RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, , Italy

Site Status RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, , Italy

Site Status RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, , Lithuania

Site Status RECRUITING

Klaipeda Hospital, Affiliate of Klaipeda University Hospital

Klaipėda, , Lithuania

Site Status RECRUITING

Leids Universitair Medisch Centrum

Leiden, , Netherlands

Site Status RECRUITING

Malopolskie Badania Kliniczne

Krakow, , Poland

Site Status RECRUITING

Zespol Poradni Specjalistycznych REUMED

Lublin, , Poland

Site Status RECRUITING

Twoja Przychodnia NCM

Nowa Sól, , Poland

Site Status RECRUITING

MICS Centrum Medyczne Warszawa

Warsaw, , Poland

Site Status RECRUITING

Niepubliczny Zaklad Opieki Zdrowotnej Biogenes

Wroclaw, , Poland

Site Status RECRUITING

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, , Portugal

Site Status RECRUITING

ULS de Santa Maria,EPE - Hospital de Santa Maria

Lisbon, , Portugal

Site Status RECRUITING

ULS de Gaia/Espinho, EPE - Unidade I

Vila Nova de Gaia, , Portugal

Site Status RECRUITING

The Alliance Medical Sciences Campus

San Juan, , Puerto Rico

Site Status RECRUITING

Sf.Maria Clinical Hospital

Bucharest, , Romania

Site Status RECRUITING

Dr I Cantacuzino Clinical Hospital

Bucharest, , Romania

Site Status RECRUITING

Military Medical Academy

Belgrade, , Serbia

Site Status RECRUITING

Hospital Del Mar

Barcelona, , Spain

Site Status RECRUITING

C.H. Regional Reina Sofia

Córdoba, , Spain

Site Status RECRUITING

Corporacio Sanitaria Parc Tauli

Sabadell, , Spain

Site Status RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, , Switzerland

Site Status RECRUITING

Universitätsspital Zürich

Zurich, , Switzerland

Site Status RECRUITING

Chapel Allerton Hospital

Leeds, , United Kingdom

Site Status RECRUITING

Royal Free Hospital

London, , United Kingdom

Site Status RECRUITING

Luton and Dunstable University Hospital

Luton, , United Kingdom

Site Status RECRUITING

Countries

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United States Argentina Belgium Bulgaria Chile Croatia Czechia Denmark France Germany Greece Hungary Italy Lithuania Netherlands Poland Portugal Puerto Rico Romania Serbia Spain Switzerland United Kingdom

Central Contacts

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Sabine Coppieters, MD

Role: CONTACT

[email protected]
857-350-4834

Facility Contacts

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Saima Chohan, MD

Role: primary

[email protected]
857-350-4834

Suzanne Kafaja, MD

Role: primary

[email protected]
857-350-4834

Guillermo Valenzuela, MD

Role: primary

[email protected]
857-350-4834

Nadera Sweiss, MD

Role: primary

[email protected]
857-350-4834

Lesley Saketkoo, MD

Role: primary

[email protected]
857-350-4834

Ami Shah, MD

Role: primary

[email protected]
857-350-4834

Fabian Mendoza-Ballesteros, MD

Role: primary

[email protected]
857-350-4834

Erica Mulcaire-Jones, MD

Role: primary

[email protected]
857-350-4834

Nora Sandorfi, MD

Role: primary

[email protected]
857-350-4834

Pablo Mannucci Walter, MD

Role: primary

[email protected]
857-350-4834

Natalia Tamborenea, MD

Role: primary

[email protected]
857-350-4834

Alejandro Arroyo, MD

Role: primary

[email protected]
857-350-4834

Sandra Fabiana Montoya, MD

Role: primary

[email protected]
857-350-4834

Mariano Gottero, MD

Role: primary

[email protected]
857-350-4834

Francisco Colombres, MD

Role: primary

[email protected]
857-350-4834

Horacio Berman, MD

Role: primary

[email protected]
857-350-4834

Vanessa Smith, MD

Role: primary

[email protected]
857-350-4834

Karin Melsens, MD

Role: primary

[email protected]
857-350-4834

Mariela Geneva-Popova, MD

Role: primary

[email protected]
857-350-4834

Vladimira Boyadzhieva, MD

Role: primary

[email protected]
857-350-4834

Maria Ines Dominguez, MD

Role: primary

[email protected]
857-350-4834

Antonia Valenzuela Vergara, MD

Role: primary

[email protected]
857-350-4834

Carlos Alberto Baumert Llanos, MD

Role: primary

[email protected]
857-350-4834

Jasminka Milas-Ahic, MD

Role: primary

[email protected]
857-350-4834

Mislav Radic, MD

Role: primary

[email protected]
857-350-4834

Kristina Frketic Marovic, MD

Role: primary

[email protected]
857-350-4834

Michal Tomcik, MD

Role: primary

[email protected]
857-350-4834

Søren Jacobsen, MD

Role: primary

[email protected]
857-350-4834

Marie-Elise Truchetet, MD

Role: primary

[email protected]
857-350-4834

Vincent Sobanski, MD

Role: primary

[email protected]
857-350-4834

Emmanuel Chatelus, MD

Role: primary

[email protected]
857-350-4834

Christian Jorgensen, MD

Role: primary

[email protected]
857-350-4834

Yannick Allanore, MD

Role: primary

[email protected]
857-350-4834

Gabriela Riemekasten, MD

Role: primary

[email protected]
857-350-4834

Gunter Assmann, MD

Role: primary

[email protected]
857-350-4834

Jörg Henes, MD

Role: primary

[email protected]
857-350-4834

Andreas Bounas, MD

Role: primary

[email protected]
857-350-4834

Dimitrios Daousis, MD

Role: primary

[email protected]
857-350-4834

Loukas Settas, MD

Role: primary

[email protected]
857-350-4834

Gabor Kumanovics, MD

Role: primary

[email protected]
857-350-4834

Silvia Bellando Randone, MD

Role: primary

[email protected]
857-350-4834

Marco Matucci Cerinic, MD

Role: primary

[email protected]
857-350-4834

Giovanna Cuomo, MD

Role: primary

[email protected]
857-350-4834

Maria Antonietta D'Agostino, MD

Role: primary

[email protected]
857-350-4834

Roberto Giacomelli, MD

Role: primary

[email protected]
857-350-4834

Maria De Santis, MD

Role: primary

[email protected]
857-350-4834

Asta Baranauskaite, MD

Role: primary

[email protected]
857-350-4834

Loreta Bukauskiene, MD

Role: primary

[email protected]
857-350-4834

Jeska de Vries-Bouwstra, MD

Role: primary

[email protected]
857-350-4834

Bogdan Batko, MD

Role: primary

[email protected]
857-350-4834

Robert Zwolak, MD

Role: primary

[email protected]
857-350-4834

Malgorzata Miakisz, MD

Role: primary

[email protected]
857-350-4834

Katarzyna Romanowska-Prochnicka, MD

Role: primary

[email protected]
857-350-4834

Piotr Wiland, MD

Role: primary

[email protected]
857-350-4834

Carina Lopes, MD

Role: primary

[email protected]
857-350-4834

Catarina Resende, MD

Role: primary

[email protected]
857-350-4834

Tiago Meirinhos, MD

Role: primary

[email protected]
857-350-4834

Grissel Rios Sola, MD

Role: primary

[email protected]
857-350-4834

Florian Berghea, MD

Role: primary

[email protected]
857-350-4834

Ana Maria Gheorghiu, MD

Role: primary

[email protected]
857-350-4834

Milan Petronijevic, MD

Role: primary

[email protected]
857-350-4834

Ana Pros Simon, MD

Role: primary

[email protected]
857-350-4834

Rafaela Ortega Castro, MD

Role: primary

[email protected]
857-350-4834

Joan Calvet Fontova, MD

Role: primary

[email protected]
857-350-4834

Frauke Förger, MD

Role: primary

[email protected]
857-350-4834

Muriel Elhai, MD

Role: primary

[email protected]
857-350-4834

Francesco Del Galdo, MD

Role: primary

[email protected]
857-350-4834

Voon Ong, MD

Role: primary

[email protected]
857-350-4834

Muhammad Nisar, MD

Role: primary

[email protected]
857-350-4834

Other Identifiers

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2024-514539-67-00

Identifier Type: CTIS

Identifier Source: secondary_id

ARGX-113-2317

Identifier Type: -

Identifier Source: org_study_id

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