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

NCT06655155 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: ARGX-113-23172024-514539-67-00
• Study Type: interventional
• Target: 81
• Locations: 24 countries
• Sites: 74

Brief 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

Conditions

Systemic Sclerosis (SSc)

Outcome Measures

Primary Outcomes (1)

• Change from baseline in mRSS at week 24

  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 Outcomes (11)

• Change from baseline in mRSS at week 48

  Up to 48 weeks

• Incidence of treatment-emergent (serious) adverse events

  Up to 55 weeks

• 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)

  Up to 48 weeks

• Change from baseline in HAQ-DI at weeks 24 and 48

  Up to 48 weeks

• Change from baseline in PGA at weeks 24 and 48

  Up to 48 weeks

Study Arms (2)

Efgartigimod PH20 SC

EXPERIMENTAL

Participants receiving efgartigimod PH20 SC

Combination Product: Efgartigimod PH20 SC

Placebo PH20 SC

PLACEBO COMPARATOR

Participants receiving placebo PH20 SC

Other: Placebo PH20 SC

Interventions

Efgartigimod PH20 SC COMBINATION_PRODUCT

Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Efgartigimod PH20 SC

Placebo PH20 SC OTHER

Subcutaneous placebo PH20 SC given by prefilled syringe

Placebo PH20 SC

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• argenx: lead

Study Sites (74)

Arizona Arthritis and Rheumatology Associates

Phoenix, Arizona, 85032-9306, United States

RECRUITING

UCLA Ronald Reagan University of California Los Angeles Medical Center

Los Angeles, California, 90095, United States

RECRUITING

IRIS Research and Development LLC

Plantation, Florida, 33324, United States

RECRUITING

University of Illinois Health Outpatient Care Center

Chicago, Illinois, 60612, United States

RECRUITING

DelRicht Research, LLC

New Orleans, Louisiana, 70112, United States

RECRUITING

Johns Hopkins Asthma and Allergy Center

Baltimore, Maryland, 21224, United States

RECRUITING

Thomas Jefferson University

Columbia, Maryland, 21044, United States

RECRUITING

University of Michigan Hospital

Ann Arbor, Michigan, 48109, United States

RECRUITING

Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

RECRUITING

Aprillus Asistencia e Investigacion

Buenos Aires, C1046AAQ, Argentina

RECRUITING

Instituto de Investigación Clínica TyT

Buenos Aires, C1405BFN, Argentina

RECRUITING

Consultorios Médicos Dr. Doreski - Fundacion Respirar

Buenos Aires, C1426ABP, Argentina

RECRUITING

Hospital General de Agudos Dr. José María Ramos Mejia

Buenos Aires, Argentina

RECRUITING

Sanatorio Allende S.A.

Córdoba, 5000, Argentina

RECRUITING

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, T4000IHE, Argentina

RECRUITING

Centro de Investigaciones Médicas Tucumán

San Miguel de Tucumán, T4000IKJ, Argentina

RECRUITING

UZ Gent

Ghent, 9000, Belgium

RECRUITING

UZ Brussel

Jette, 1090, Belgium

RECRUITING

Medical Center Artmed OOD

Plovdiv, 4002, Bulgaria

RECRUITING

Diagnostic Consultative Center Convex EOOD

Sofia, 1680, Bulgaria

RECRUITING

BIOCINETIC Ltda

Santiago, 8320000, Chile

RECRUITING

Centro de Investigaciones Clinicas UC (CICUC)

Santiago, 8330034, Chile

RECRUITING

Centro de especialidades médicas Vanguardia

Temuco, 4810345, Chile

RECRUITING

Clinical Hospital Centre Osijek

Osijek, 31000, Croatia

RECRUITING

University Hospital of Split

Split, 21000, Croatia

RECRUITING

General Hospital Zadar

Zadar, 23000, Croatia

RECRUITING

Revmatologicky Ustav

Prague, 140 59, Czechia

RECRUITING

Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

CHU de Bordeaux - Hôpital Pellegrin

Bordeaux, 33000, France

RECRUITING

CHU de Lille - Hopital Claude Huriez

Lille, 59000, France

RECRUITING

CHU de Strasbourg - Hôpital de Hautepierre

Marseille, 13274, France

RECRUITING

CHU de Montpellier- Hôpital Saint Eloi

Montpellier, 34090, France

RECRUITING

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

Paris, 75014, France

RECRUITING

Universitätsklinikum Schleswig-Holstein - Campus Lübeck

Lübeck, 23562, Germany

RECRUITING

Mühlenkreiskliniken - Johannes Wesling Klinikum Minden

Minden, 32429, Germany

RECRUITING

Universitätsklinikum Tübingen

Tübingen, 72076, Germany

RECRUITING

Olympion General Clinic

Pátrai, 264 43, Greece

RECRUITING

University General Hospital of Patras

Pátrai, 265 04, Greece

RECRUITING

Euromedica Kianous Stavros

Thessaloniki, 546 36, Greece

RECRUITING

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

Pécs, 7632, Hungary

RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

RECRUITING

Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

RECRUITING

Azienda Ospedaliera Universitaria Luigi Vanvitelli

Naples, 80131, Italy

RECRUITING

Fondazione Policlinico Universitario A. Gemelli IRCCS

Roma, 00168, Italy

RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, 128, Italy

RECRUITING

IRCCS Istituto Clinico Humanitas

Rozzano, 20089, Italy

RECRUITING

Hospital of Lithuanian University of Health Sciences Kauno klinikos

Kaunas, 50161, Lithuania

RECRUITING

Klaipeda Hospital, Affiliate of Klaipeda University Hospital

Klaipėda, LT-92288, Lithuania

RECRUITING

Mediadvance Clinical S.A.P.I. de C.V.

Chihuahua City, 31203, Mexico

RECRUITING

Centro Integral Reumatologia SA de CV

Guadalajara, 44160, Mexico

RECRUITING

Centro de Investigación y Tratamiento Reumatológico S.C

Mexico City, 11850, Mexico

RECRUITING

Medical Care and Research S.A. de C.V.

Mérida, 97070, Mexico

RECRUITING

Leids Universitair Medisch Centrum

Leiden, 2333 ZA, Netherlands

RECRUITING

Malopolskie Badania Kliniczne

Krakow, 30-002, Poland

RECRUITING

Zespol Poradni Specjalistycznych REUMED

Lublin, 20-607, Poland

RECRUITING

Twoja Przychodnia NCM

Nowa Sól, 67-100, Poland

RECRUITING

MICS Centrum Medyczne Warszawa

Warsaw, 00-874, Poland

RECRUITING

Niepubliczny Zaklad Opieki Zdrowotnej Biogenes

Wroclaw, 53-224, Poland

RECRUITING

ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz

Lisbon, 1349-019, Portugal

RECRUITING

ULS de Santa Maria,EPE - Hospital de Santa Maria

Lisbon, 1649-035, Portugal

RECRUITING

ULS de Gaia/Espinho, EPE - Unidade I

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

The Alliance Medical Sciences Campus

San Juan, 00936, Puerto Rico

RECRUITING

Sf.Maria Clinical Hospital

Bucharest, 11172, Romania

RECRUITING

Dr I Cantacuzino Clinical Hospital

Bucharest, 20475, Romania

RECRUITING

Institute of Rheumatology - PPDS

Belgrade, 11000, Serbia

RECRUITING

Military Medical Academy

Belgrade, 11152, Serbia

RECRUITING

Hospital Del Mar

Barcelona, 8023, Spain

RECRUITING

C.H. Regional Reina Sofia

Córdoba, 14004, Spain

RECRUITING

Corporacio Sanitaria Parc Tauli

Sabadell, 08208, Spain

RECRUITING

Kantonsspital St. Gallen

Sankt Gallen, 9000, Switzerland

RECRUITING

Universitätsspital Zürich

Zurich, 8090, Switzerland

RECRUITING

Chapel Allerton Hospital

Leeds, LS7 4SA, United Kingdom

RECRUITING

Royal Free Hospital

London, NW3 2QG, United Kingdom

RECRUITING

Luton and Dunstable University Hospital

Luton, LU4 0DZ, United Kingdom

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Sabine Coppieters, MD

CONTACT

857-350-4834; clinicaltrials@argenx.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2024
• First Posted: October 23, 2024
• Study Start: November 11, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): September 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AR (7); GR (3); PT (3); BE (2); BU (2); CZ (1); DE (3); LI (2); GB (3); CL (3); FR (5); CR (3); DK (1); PL (5); SE (2); NL (1); HU (1); US (9); CH (2); PR (1); IT (6); ES (3); RO (2); ME (4)