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

Description

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.

Conditions

Systemic Sclerosis (SSc)

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Systemic Sclerosis (SSc)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Arizona Arthritis and Rheumatology Associates, Phoenix, Arizona, United States, 85032-9306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

argenx,

Study Record Dates

2027-06-14