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Study of Efgartigimod PH20 SC for Systemic Sclerosis

This study is looking at how well and how safely a medicine called efgartigimod PH20 SC works for adults with systemic sclerosis (a disease that causes hardening of the skin and other organs). You might be able to join if you are at least 18 years old, have a diagnosis of systemic sclerosis, and have a positive ANA (antinuclear antibodies) test result of at least 1:160. The main goal is to see how much your skin hardening improves after 24 weeks. This study is currently unclear on its recruitment status and plans to enroll 81 participants.

Study design
This study is interventional and will randomly assign participants to receive either efgartigimod PH20 SC or a placebo (an inactive substance) in a 2:1 ratio. The phase of the study is not specified.
What's involved
After an initial screening, you would receive treatment for up to 48 weeks, followed by a safety check-up period. The total study could last up to about 15 months.
Compensation
Not stated in the trial record.
Follow-up
The study includes a safety follow-up period after the treatment period, but the exact duration is not specified.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06655155

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

Recruiting
PHASE2Ages 18+InterventionalTreatment
argenx
~81 participants
Updated 2026-08-21 on ClinicalTrials.gov
What's tested:Efgartigimod PH20 SCPlacebo PH20 SC

At a glance

Recruiting sites
77 of 77 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Change from baseline in mRSS at week 24
Measured over Up to 24 weeks

Conditions

Systemic Sclerosis (SSc)

Explore related trials

Systemic SclerodermaAntinuclear Antibody

Where it's being run

77 sites across 31 states
Argentina8
Italy7
France5
Poland5
Germany4
Mexico4
Chile3
Croatia3

Who to contact

Sabine Coppieters, MD
[email protected]
857-350-4834
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Change from baseline in mRSS at week 24Up to 24 weeks

    The Modified Rodnan Skin Score is a scoring tool to assess skin thickness in 17 cutaneous sites across the body. Each site is rated on a semiquantitative score ranging from 0 (normal) to 3 (severe). The total score is the sum of the individual skin scores and can range from 0 to 51.