Systemic Sclerosis (SSc) Clinical Trials

Find Systemic Sclerosis (SSc) Clinical Trials Near You

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

Status: Recruiting
Location: See all (68) locations...
Intervention Type: Other, Combination product
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
United States
Arizona
Arizona Arthritis and Rheumatology Associates
RECRUITING
Phoenix
California
UCLA Ronald Reagan University of California Los Angeles Medical Center
RECRUITING
Los Angeles
Florida
IRIS Research and Development LLC
RECRUITING
Plantation
Illinois
University of Illinois Health Outpatient Care Center
RECRUITING
Chicago
Louisiana
DelRicht Research, LLC
RECRUITING
New Orleans
Maryland
Johns Hopkins Asthma and Allergy Center
RECRUITING
Baltimore
Thomas Jefferson University
RECRUITING
Columbia
Michigan
University of Michigan Hospital
RECRUITING
Ann Arbor
Pennsylvania
Perelman Center for Advanced Medicine
RECRUITING
Philadelphia
Other Locations
Argentina
Aprillus Asistencia e Investigacion
RECRUITING
Buenos Aires
Consultorios Médicos Dr. Doreski - Fundacion Respirar
RECRUITING
Buenos Aires
Hospital General de Agudos Dr. José María Ramos Mejia
RECRUITING
Buenos Aires
Instituto de Investigación Clínica TyT
RECRUITING
Buenos Aires
Sanatorio Allende S.A.
RECRUITING
Córdoba
Centro de Investigaciones Médicas Tucumán
RECRUITING
San Miguel De Tucumán
Clínica Mayo de U.M.C.B. S.R.L
RECRUITING
San Miguel De Tucumán
Belgium
UZ Gent
RECRUITING
Ghent
UZ Brussel
RECRUITING
Jette
Bulgaria
Medical Center Artmed OOD
RECRUITING
Plovdiv
Diagnostic Consultative Center Convex EOOD
RECRUITING
Sofia
Chile
BIOCINETIC Ltda
RECRUITING
Santiago
Centro de Investigaciones Clinicas UC (CICUC)
RECRUITING
Santiago
Centro de especialidades médicas Vanguardia
RECRUITING
Temuco
Croatia
Clinical Hospital Centre Osijek
RECRUITING
Osijek
University Hospital of Split
RECRUITING
Split
General Hospital Zadar
RECRUITING
Zadar
Denmark
Rigshospitalet
RECRUITING
Copenhagen
France
CHU de Bordeaux - Hôpital Pellegrin
RECRUITING
Bordeaux
CHU de Lille - Hopital Claude Huriez
RECRUITING
Lille
CHU de Strasbourg - Hôpital de Hautepierre
RECRUITING
Marseille
CHU de Montpellier- Hôpital Saint Eloi
RECRUITING
Montpellier
AP-HP - Hôpital Cochin - Port-Royal, site Cochin
RECRUITING
Paris
Germany
Universitätsklinikum Schleswig-Holstein - Campus Lübeck
RECRUITING
Lübeck
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden
RECRUITING
Minden
Universitätsklinikum Tübingen
RECRUITING
Tübingen
Greece
Olympion General Clinic
RECRUITING
Pátrai
University General Hospital of Patras
RECRUITING
Pátrai
Euromedica Kianous Stavros
RECRUITING
Thessaloniki
Hungary
Pecsi Tudomanyegyetem, Klinika Kozpont, Bor, Nemikortani es Onkodermatologiai Klinika
RECRUITING
Pécs
Italy
Azienda Ospedaliera Universitaria Careggi
RECRUITING
Florence
Ospedale San Raffaele S.r.l.
RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli
RECRUITING
Naples
Fondazione Policlinico Universitario A. Gemelli IRCCS
RECRUITING
Roma
Fondazione Policlinico Universitario Campus Bio-Medico
RECRUITING
Roma
IRCCS Istituto Clinico Humanitas
RECRUITING
Rozzano
Lithuania
Hospital of Lithuanian University of Health Sciences Kauno klinikos
RECRUITING
Kaunas
Klaipeda Hospital, Affiliate of Klaipeda University Hospital
RECRUITING
Klaipėda
Netherlands
Leids Universitair Medisch Centrum
RECRUITING
Leiden
Poland
Malopolskie Badania Kliniczne
RECRUITING
Krakow
Zespol Poradni Specjalistycznych REUMED
RECRUITING
Lublin
Twoja Przychodnia NCM
RECRUITING
Nowa Sól
MICS Centrum Medyczne Warszawa
RECRUITING
Warsaw
Niepubliczny Zaklad Opieki Zdrowotnej Biogenes
RECRUITING
Wroclaw
Portugal
ULS de Lisboa Ocidental, EPE - Hospital Egas Moniz
RECRUITING
Lisbon
ULS de Santa Maria,EPE - Hospital de Santa Maria
RECRUITING
Lisbon
ULS de Gaia/Espinho, EPE - Unidade I
RECRUITING
Vila Nova De Gaia
Puerto Rico
The Alliance Medical Sciences Campus
RECRUITING
San Juan
Romania
Dr I Cantacuzino Clinical Hospital
RECRUITING
Bucharest
Sf.Maria Clinical Hospital
RECRUITING
Bucharest
Serbia
Military Medical Academy
RECRUITING
Belgrade
Spain
Hospital Del Mar
RECRUITING
Barcelona
C.H. Regional Reina Sofia
RECRUITING
Córdoba
Corporacio Sanitaria Parc Tauli
RECRUITING
Sabadell
Switzerland
Kantonsspital St. Gallen
RECRUITING
Sankt Gallen
Universitätsspital Zürich
RECRUITING
Zurich
United Kingdom
Chapel Allerton Hospital
RECRUITING
Leeds
Royal Free Hospital
RECRUITING
London
Luton and Dunstable University Hospital
RECRUITING
Luton
Contact Information
Primary
Sabine Coppieters, MD
clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-11-11
Estimated Completion Date: 2027-06-14
Participants
Target number of participants: 81
Treatments
Experimental: Efgartigimod PH20 SC
Participants receiving efgartigimod PH20 SC
Placebo_comparator: Placebo PH20 SC
Participants receiving placebo PH20 SC
Related Therapeutic Areas
Scleroderma
Systemic Sclerosis (SSc)
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov

Similar Clinical Trials

Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

Randomized, Double-blind, Placebo-controlled Proof-of-Concept (PoC) Study to Evaluate the Efficacy, Safety, and Tolerability of Efzofitimod in Patients With Systemic Sclerosis (SSc)-Related Interstitial Lung Disease (ILD) (SSc-ILD)

Enrollment Status: Recruiting
Publish Date: May 07, 2025
Intervention Type: Drug
Study Phase: Phase 2

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF

A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF

Enrollment Status: Recruiting
Publish Date: April 06, 2026
Intervention Type: Drug, Other
Study Phase: Phase 2

A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis

A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis

Enrollment Status: Recruiting
Publish Date: February 12, 2026
Intervention Type: Other, Biological
Study Phase: Phase 2
View All