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Evaluating the effects of efgartigimod PH20 SC in adults with systemic sclerosis

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

PHASE2 · argenx · NCT06655155

This study is testing a new drug called efgartigimod PH20 SC to see if it helps adults with systemic sclerosis feel better and improve their health over about 15 months.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment81 (estimated)
Ages18 Years and up
SexAll
Sponsorargenx (industry)
Locations74 sites (Phoenix, Arizona and 73 other locations)
Trial IDNCT06655155 on ClinicalTrials.gov

What this trial studies

This study aims to assess the efficacy and safety of efgartigimod PH20 SC in adults diagnosed with systemic sclerosis (SSc). Participants will undergo a screening period followed by a treatment phase lasting up to 48 weeks, where they will be randomly assigned to receive either the active drug or a placebo. The study will also include a safety follow-up period, making the total duration approximately 15 months. The primary focus is on measuring the drug's impact on symptoms and overall health in individuals with SSc.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a confirmed diagnosis of diffuse or limited systemic sclerosis who meet specific clinical criteria.

Not a fit: Patients with isolated anticentromere antibodies may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve the quality of life for patients suffering from systemic sclerosis.

How similar studies have performed: While this approach is being evaluated in this context, similar studies have shown promise in treating autoimmune conditions, suggesting potential for success.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Phoenix, Arizona and 73 other locations

+24 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Systemic Sclerosis

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.