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ClinicalTrials.gov ID

NCT06655155

Lead Sponsor

argenxINDUSTRY

Overall Status

Recruiting

Study Type

Interventional

Phase

Phase 2

Enrollment

81Estimated

Last Update Posted

Aug 21, 2026Actual

Start Date

Nov 11, 2024Actual

Primary Completion Date

Feb 2027Estimated

Completion Date

Sep 2027Estimated

Official Title

A Randomized, Double-Blinded, Placebo-Controlled, Phase 2, Parallel-Group Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of Efgartigimod PH20 SC in Adult Participants With Systemic Sclerosis

Brief Summary

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

• Systemic Sclerosis (SSc)

• Efgartigimod PH20 SC
• Placebo PH20 SC

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

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

Primary Purpose

Treatment

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

Quadruple

Lead Sponsor

argenxINDUSTRY

vanessa.smith@ugent.com+3293322856