A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
ConditionSystemic Sclerosis (SSc)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
Sponsorargenx
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
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- Efgartigimod PH20 SC
- Placebo PH20 SC
Treatment groups
81 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov