At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Efgartigimod PH20 SC (combination product), Placebo PH20 SC (other)
- How long the study runs
- Study runs about 34 months (dates as stated)
- About the drug or intervention
- Efgartigimod PH20 SC — combination product: Subcutaneous efgartigimod PH20 SC given by prefilled syringe · Placebo PH20 SC — other: Subcutaneous placebo PH20 SC given by prefilled syringe
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 81
- Started
- 2024-11-11
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for systemic sclerosis (ssc)
- • Phase2 - 81 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with systemic sclerosis (ssc)
Where?
- • Leeds - Chapel Allerton Hospital
- • London - Royal Free Hospital
- • Luton - Luton and Dunstable University Hospital
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What 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...
- ✓Has a modified Rodnan Skin Score (mRSS) score between 15 and 35
Who cannot take part
- ✗Isolated anticentromere antibodies (ACA) seropositivity at the central laboratory
- ✗Significant lung Arterial Hypertension
- ✗Severe digital vasculopathy within the past 3 months
- ✗Skin thickening due to scleroderma mimics or localized scleroderma
- ✗Scleroderma kidney crisis within the past 6 months of participating to the study
See the full criteria
Where Is This Study? (3 UK sites)
Chapel Allerton Hospital
Leeds LS7 4SA, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Luton and Dunstable University Hospital
Luton LU4 0DZ, United Kingdom
How to Get in Touch
Sabine Coppieters, MD
Sponsor contactCONTACT