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Clinical Trials in the UK / NCT06655155
Recruiting Phase 2

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

NCT06655155 · tracked via the Priya Life Science UK tracker
Sponsor
argenx
Phase
Phase 2
Started
2024-11-11
Last updated
2026-09-17

Condition(s) studied

Systemic Sclerosis (SSc)

Investigational drug(s) / intervention(s)

Efgartigimod PH20 SCPlacebo PH20 SC

Efgartigimod PH20 SC: Subcutaneous efgartigimod PH20 SC given by prefilled syringe

Placebo PH20 SC: Subcutaneous placebo PH20 SC given by prefilled syringe

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (78)

FacilityCityRegionStatus
Arizona Arthritis and Rheumatology Associates Phoenix Arizona Recruiting
UCLA Ronald Reagan University of California Los Angeles Medical Center Los Angeles California Recruiting
IRIS Research and Development LLC Plantation Florida Recruiting
University of Illinois Health Outpatient Care Center Chicago Illinois Recruiting
DelRicht Research, LLC New Orleans Louisiana Recruiting
Johns Hopkins Asthma and Allergy Center Baltimore Maryland Recruiting
Thomas Jefferson University Columbia Maryland Recruiting
University of Michigan Hospital Ann Arbor Michigan Recruiting
Perelman Center for Advanced Medicine Philadelphia Pennsylvania Recruiting
Aprillus Asistencia e Investigacion Buenos Aires Argentina Recruiting
Instituto de Investigación Clínica TyT Buenos Aires Argentina Recruiting
Consultorios Médicos Dr. Doreski - Fundacion Respirar Buenos Aires Argentina Recruiting
Hospital General de Agudos Dr. José María Ramos Mejia Buenos Aires Argentina Recruiting
Sanatorio Allende S.A. Córdoba Argentina Recruiting
Centro de Investigaciones Reumatológicas San Miguel de Tucumán Argentina Recruiting
Clínica Mayo de U.M.C.B. S.R.L San Miguel de Tucumán Argentina Recruiting
Centro de Investigaciones Médicas Tucumán San Miguel de Tucumán Argentina Recruiting
UZ Gent Ghent Belgium Recruiting
UZ Brussel Jette Belgium Recruiting
Medical Center Artmed OOD Plovdiv Bulgaria Recruiting
Diagnostic Consultative Center Convex EOOD Sofia Bulgaria Recruiting
BIOCINETIC Ltda Santiago Chile Recruiting
Centro de Investigaciones Clinicas UC (CICUC) Santiago Chile Recruiting
Centro de especialidades médicas Vanguardia Temuco Chile Recruiting
Clinical Hospital Centre Osijek Osijek Croatia Recruiting
University Hospital of Split Split Croatia Recruiting
General Hospital Zadar Zadar Croatia Recruiting
Revmatologicky Ustav Prague Czechia Recruiting
Rigshospitalet Copenhagen Denmark Recruiting
CHU de Bordeaux - Hôpital Pellegrin Bordeaux France Recruiting
CHU de Lille - Hopital Claude Huriez Lille France Recruiting
CHU de Strasbourg - Hôpital de Hautepierre Marseille France Recruiting
CHU de Montpellier- Hôpital Saint Eloi Montpellier France Recruiting
AP-HP - Hôpital Cochin - Port-Royal, site Cochin Paris France Recruiting
Auenlandklinik Bad Bramstedt GmbH Bad Bramstedt Germany Recruiting
Universitätsklinikum Schleswig-Holstein - Campus Lübeck Lübeck Germany Recruiting
Mühlenkreiskliniken - Johannes Wesling Klinikum Minden Minden Germany Recruiting
Universitätsklinikum Tübingen Tübingen Germany Recruiting
Olympion General Clinic Pátrai Greece Recruiting
University General Hospital of Patras Pátrai Greece Recruiting

+ 38 more sites — see the full list on the official registry below.

More argenx trials in the UK

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06655155 on ClinicalTrials.gov ↗ ← All trials in the UK