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

argenx

Status and phase: Enrolling; Phase 2

Conditions: Systemic Sclerosis (SSc)

Treatments: Combination Product: Efgartigimod PH20 SC; Other: Placebo PH20 SC

Study type: Interventional

Funder types: Industry

Identifiers

NCT06655155

2024-514539-67-00 (EU Trial (CTIS) Number)

ARGX-113-2317

Details and patient eligibility

About

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.

Enrollment: 81 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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81 participants in 2 patient groups, including a placebo group

Efgartigimod PH20 SC

Experimental group

Description:

Participants receiving efgartigimod PH20 SC

Treatment:

Combination Product: Efgartigimod PH20 SC

Placebo PH20 SC

Placebo Comparator group

Description:

Participants receiving placebo PH20 SC

Treatment:

Other: Placebo PH20 SC