NCT06655155Active, not recruitingPhase 2
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
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
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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
- Status (registry)
- Active, not recruiting
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 87 (actual)
- First submitted
- 22 Oct 2024
- Start date
- 11 Nov 2024
- Primary completion date
- Mar 2027
- Lead sponsor
- argenx
- Diseases
- Systemic sclerosis (scleroderma)
- NCT number
- NCT06655155
- EU CT number
- 2024-514539-67-00
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 87
- From 11 Nov 2024 to the primary completion date, Mar 2027
- 77 sites in 24 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Significant Pulmonary Arterial Hypertension
- Another rheumatic autoimmune disease, except for secondary Sjögren's syndrome or fibromyalgia
Lab values
- Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (77)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Instituto de Investigación Clínica TyT Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Hospital General de Agudos Dr. José María Ramos Mejia Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Consultorios Medicos Dr. Doreski - Fundacion Respirar Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Aprillus Asistencia e Investigación Coordinator of this site? Confirm its status | Buenos Aires | Argentina | Unknown status |
| Sanatorio Allende S.A. Coordinator of this site? Confirm its status | Córdoba | Argentina | Unknown status |
| Centro de Investigaciones Medicas Tucuman Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Centro de Investigaciones Reumatológicas Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Clinica Mayo de U.M.C.B. S.R.L Coordinator of this site? Confirm its status | San Miguel de Tucumán | Argentina | Unknown status |
| Universitair Ziekenhuis Gent Coordinator of this site? Confirm its status | Gent | Belgium | Active, not recruiting |
| UZ Brussel Coordinator of this site? Confirm its status | Jette | Belgium | Active, not recruiting |
| Diagnostics And Consultation Center Convex Ltd. Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Active, not recruiting |
| Kantonsspital St. Gallen Coordinator of this site? Confirm its status | Sankt Gallen | Switzerland | Unknown status |
| Universitätsspital Zürich Coordinator of this site? Confirm its status | Zurich | Switzerland | Unknown status |
| Centro de Investigaciones Clinicas UC CICUC Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Biocinetic Ltda Coordinator of this site? Confirm its status | Santiago | Chile | Unknown status |
| Centro de especialidades médicas Vanguardia Coordinator of this site? Confirm its status | Temuco | Chile | Unknown status |
| Revmatologicky Ustav Coordinator of this site? Confirm its status | Prague 2 | Czechia | Active, not recruiting |
| Klinikum Bad Bramstedt GmbH Coordinator of this site? Confirm its status | Bad Bramstedt | Germany | Active, not recruiting |
| Universitaetsklinikum Schleswig-Holstein AöR Coordinator of this site? Confirm its status | Luebeck | Germany | Active, not recruiting |
| Johannes Wesling Klinikum Minden Coordinator of this site? Confirm its status | Minden | Germany | Active, not recruiting |
| Universitaetsklinikum Tuebingen AöR Coordinator of this site? Confirm its status | Tuebingen | Germany | Active, not recruiting |
| Rigshospitalet Coordinator of this site? Confirm its status | Copenhagen Oe | Denmark | Completed |
| Hospital del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Active, not recruiting |
| Hospital Universitario Reina Sofia Coordinator of this site? Confirm its status | Córdoba | Spain | Active, not recruiting |
| Parc Tauli Hospital Universitari Coordinator of this site? Confirm its status | Sabadell | Spain | Active, not recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Active, not recruiting |
| Hopital Huriez Coordinator of this site? Confirm its status | Lille Cedex | France | Active, not recruiting |
| Centre Hospitalier Universitaire de Montpellier Coordinator of this site? Confirm its status | Montpellier | France | Active, not recruiting |
| Assistance Publique Hopitaux de Paris Coordinator of this site? Confirm its status | Paris | France | Active, not recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Active, not recruiting |
| Chapel Allerton Hospital Coordinator of this site? Confirm its status | Leeds | United Kingdom | Unknown status |
| Royal Free Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Unknown status |
| Luton and Dunstable University Hospital Coordinator of this site? Confirm its status | Luton | United Kingdom | Unknown status |
| Olympion Therapeftirio General Clinic Of Patras S.A. Coordinator of this site? Confirm its status | Patra | Greece | Active, not recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Active, not recruiting |
| Euromedica Kyanous Stavros Coordinator of this site? Confirm its status | Thessaloniki | Greece | Active, not recruiting |
| Klinički bolnički centar Osijek Coordinator of this site? Confirm its status | Osijek | Croatia | Active, not recruiting |
| KBC Split Coordinator of this site? Confirm its status | Split | Croatia | Active, not recruiting |
| Opca bolnica Zadar Coordinator of this site? Confirm its status | Zadar | Croatia | Active, not recruiting |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Active, not recruiting |
| Ospedale San Raffaele S.r.l. Coordinator of this site? Confirm its status | Milan | Italy | Active, not recruiting |
| Azienda Ospedaliero - Universitaria di Modena Coordinator of this site? Confirm its status | Modena | Italy | Active, not recruiting |
| Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi Vanvitelli Coordinator of this site? Confirm its status | Naples | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Agostino Gemelli IRCCS Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon Coordinator of this site? Confirm its status | Rome | Italy | Active, not recruiting |
| Humanitas Mirasole S.p.A. Coordinator of this site? Confirm its status | Rozzano | Italy | Active, not recruiting |
| Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Coordinator of this site? Confirm its status | Kaunas | Lithuania | Active, not recruiting |
| Klaipedos universiteto ligonine VšĮ Coordinator of this site? Confirm its status | Klaipeda | Lithuania | Active, not recruiting |
| Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran Coordinator of this site? Confirm its status | Belisario Domínguez | Mexico | Unknown status |
| Mediadvance Clinical S.A.P.I de C.V. Coordinator of this site? Confirm its status | Chihuahua City | Mexico | Unknown status |
| Centro Integral Reumatologia SA de CV Coordinator of this site? Confirm its status | Guadalajara | Mexico | Unknown status |
| Medical Care and Research S.A. de C.V. Coordinator of this site? Confirm its status | Mérida | Mexico | Unknown status |
| Centro de Investigación y Tratamiento Reumatológico S.C Coordinator of this site? Confirm its status | Mexico City | Mexico | Unknown status |
| Leids Universitair Medisch Centrum (LUMC) Coordinator of this site? Confirm its status | Leiden | Netherlands | Active, not recruiting |
| Malopolskie Badania Kliniczne Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Active, not recruiting |
| Reumed Sp. z o.o. Coordinator of this site? Confirm its status | Lublin | Poland | Active, not recruiting |
| Twoja Przychodnia Nowosolskie Centrum Medyczne Sp. z o.o. Coordinator of this site? Confirm its status | Nowa Sol | Poland | Active, not recruiting |
| MICS Centrum Medyczne Warszawa, Medicover Integrated Clinical Services Sp. z o.o Coordinator of this site? Confirm its status | Warszawa | Poland | Active, not recruiting |
| Niepubliczny Zaklad Opieki Zdrowotnej Biogenes Sp. z o.o Coordinator of this site? Confirm its status | Wroclaw | Poland | Active, not recruiting |
| The Alliance Medical Sciences Campus Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Unidade Local De Saude De Santa Maria E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Unidade Local De Saude De Lisboa Ocidental E.P.E. Coordinator of this site? Confirm its status | Lisbon | Portugal | Active, not recruiting |
| Unidade Local de Saúde de Gaia/Espinho, E. P. E Coordinator of this site? Confirm its status | Vila Nova de Gaia | Portugal | Active, not recruiting |
| Spitalul Clinic Dr. I. Cantacuzino Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Saint Maria Hospital Coordinator of this site? Confirm its status | Bucharest | Romania | Active, not recruiting |
| Institute of Rheumatology - PPDS Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| Military Medical Academy Coordinator of this site? Confirm its status | Belgrade | Serbia | Unknown status |
| University of Michigan Hospital Coordinator of this site? Confirm its status | Ann Arbor | United States | Unknown status |
| Johns Hopkins Asthma and Allergy Center Coordinator of this site? Confirm its status | Baltimore | United States | Unknown status |
| University of Illinois Health Outpatient Care Center Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Thomas Jefferson University Coordinator of this site? Confirm its status | Columbia | United States | Unknown status |
| UCLA Ronald Reagan University of California Los Angeles Medical Center Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| DelRicht Research, LLC Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| Perelman Center for Advanced Medicine Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Arizona Arthritis and Rheumatology Associates Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| IRIS Research and Development LLC Coordinator of this site? Confirm its status | Plantation | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.