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

a study on Systemic Sclerosis

Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at Los Angeles, California and other locations
Dates
study started
study ends around

Description

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.

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

Keywords

Systemic Sclerosis (SSc), Systemic Scleroderma, Efgartigimod PH20 SC

Eligibility

You can join if…

Open to people ages 18 years and up

  • 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

You CAN'T join if...

  • 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

Locations

  • UCLA Ronald Reagan University of California Los Angeles Medical Center accepting new patients
    Los Angeles California 90095 United States
  • Arizona Arthritis and Rheumatology Associates accepting new patients
    Phoenix Arizona 85032-9306 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
argenx
ID
NCT06655155
Phase
Phase 2 Systemic Sclerosis Research Study
Study Type
Interventional
Participants
Expecting 81 study participants
Last Updated