Efgartigimod for Adults With Systemic Sclerosis
A Study to Assess the Efficacy and Safety of Efgartigimod PH20 SC in Adults With Systemic Sclerosis
Recruiting
Phase 2
Interventional Study
Systemic Sclerosis (SSc)
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 81 (estimated)
- Sponsor
- argenx · Industry
Who this trial is looking for
This trial is looking for adults with systemic sclerosis, a condition that affects the skin and internal organs. Participants will receive either the treatment efgartigimod or a placebo over a period of up to 48 weeks, followed by a safety check.
Are You a Good Fit for This Trial?
You may be able to join if
- I am at least 18 years old.
- I have been diagnosed with systemic sclerosis.
- My test result shows antinuclear antibodies at a titer of at least 1:160.
- I have a HAQ-DI score of at least 0.5 or a PGA score of at least 3.
- My modified Rodnan Skin Score is between 15 and 35.
- I have not had anti-RNA polymerase III antibodies, with my first symptoms appearing less than 5 years ago, or I have these antibodies with symptoms appearing less than 2 years ago.
- I have at least one area of skin that is not severely thickened for the injection site.
You may not be able to join if
- I have isolated anticentromere antibodies.
- I have significant pulmonary arterial hypertension.
- I have had severe digital vasculopathy in the past 3 months.
- I have skin thickening from scleroderma mimics or localized scleroderma.
- I have had a scleroderma renal crisis in the past 6 months.
- I have another rheumatic autoimmune disease.
Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
Check Your Eligibility
About This Trial
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 tota…
Trial Locations
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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…
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