A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Recruiting now · Phase 2 · Has a placebo group
Conditions studied: Systemic Sclerosis (SSc)
In brief
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
Key facts
- Study ID
- NCT06655155
- Run by
- argenx
- People needed
- 81
- Starts
- 2024-11-11
- Expected to finish
- 2027-09-01
- Last updated by the study team
- 2026-07-21
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
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
Where it is running
- UCLA Ronald Reagan University of California Los Angeles Medical Center — Los Angeles, California, United States (enrolling)
- IRIS Research and Development LLC — Plantation, Florida, United States (enrolling)
- University of Illinois Health Outpatient Care Center — Chicago, Illinois, United States (enrolling)
- DelRicht Research, LLC — New Orleans, Louisiana, United States (enrolling)
- Johns Hopkins Asthma and Allergy Center — Baltimore, Maryland, United States (enrolling)
- Thomas Jefferson University — Columbia, Maryland, United States (enrolling)
- University of Michigan Hospital — Ann Arbor, Michigan, United States (enrolling)
- Perelman Center for Advanced Medicine — Philadelphia, Pennsylvania, United States (enrolling)
- Aprillus Asistencia e Investigacion — Buenos Aires, Argentina (enrolling)
- Instituto de Investigación Clínica TyT — Buenos Aires, Argentina (enrolling)
- Consultorios Médicos Dr. Doreski - Fundacion Respirar — Buenos Aires, Argentina (enrolling)
- Hospital General de Agudos Dr. José María Ramos Mejia — Buenos Aires, Argentina (enrolling)
- Sanatorio Allende S.A. — Córdoba, Argentina (enrolling)
- Centro de Investigaciones Reumatológicas — San Miguel de Tucumán, Argentina (enrolling)
- Clínica Mayo de U.M.C.B. S.R.L — San Miguel de Tucumán, Argentina (enrolling)
- Centro de Investigaciones Médicas Tucumán — San Miguel de Tucumán, Argentina (enrolling)
- UZ Gent — Ghent, Belgium (enrolling)
- UZ Brussel — Jette, Belgium (enrolling)
- Medical Center Artmed OOD — Plovdiv, Bulgaria (enrolling)
- Diagnostic Consultative Center Convex EOOD — Sofia, Bulgaria (enrolling)
- BIOCINETIC Ltda — Santiago, Chile (enrolling)
- Centro de Investigaciones Clinicas UC (CICUC) — Santiago, Chile (enrolling)
- Centro de especialidades médicas Vanguardia — Temuco, Chile (enrolling)
- Clinical Hospital Centre Osijek — Osijek, Croatia (enrolling)
- Arizona Arthritis and Rheumatology Associates — Phoenix, Arizona, United States (enrolling)
Full record on ClinicalTrials.gov
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