A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Purpose
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
Condition
- Systemic Sclerosis (SSc)
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Efgartigimod PH20 SC |
Participants receiving efgartigimod PH20 SC |
|
|
Placebo Comparator Placebo PH20 SC |
Participants receiving placebo PH20 SC |
|
Recruiting Locations
Arizona Arthritis and Rheumatology Associates
Phoenix, Arizona 85032-9306
Phoenix, Arizona 85032-9306
UCLA Ronald Reagan University of California Los Angeles Medical Center
Los Angeles, California 90095
Los Angeles, California 90095
IRIS Research and Development LLC
Plantation, Florida 33324
Plantation, Florida 33324
University of Illinois Health Outpatient Care Center
Chicago, Illinois 60612
Chicago, Illinois 60612
DelRicht Research, LLC
New Orleans, Louisiana 70112
New Orleans, Louisiana 70112
Johns Hopkins Asthma and Allergy Center
Baltimore, Maryland 21224
Baltimore, Maryland 21224
Thomas Jefferson University
Columbia, Maryland 21044
Columbia, Maryland 21044
University of Michigan Hospital
Ann Arbor, Michigan 48109
Ann Arbor, Michigan 48109
Perelman Center for Advanced Medicine
Philadelphia, Pennsylvania 19104
Philadelphia, Pennsylvania 19104
The Alliance Medical Sciences Campus
San Juan, Puerto Rico 00936
San Juan, Puerto Rico 00936
More Details
- Status
- Recruiting
- Sponsor
- argenx