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Study on the Effectiveness and Safety of Efgartigimod PH20 SC for Adults with Systemic Sclerosis

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying a condition known as Systemic Sclerosis, a disease that causes the skin and connective tissues to harden and tighten. The study will evaluate a treatment called efgartigimod PH20 SC, which is a solution for injection. This treatment is being compared to a placebo to see how effective it is in reducing skin thickening in people with Systemic Sclerosis.

The purpose of the study is to assess the effectiveness and safety of efgartigimod PH20 SC. Participants in the study will receive either the treatment or a placebo. The study will monitor changes in skin condition over a period of time, specifically looking at improvements in skin thickness and overall health. Participants will be observed for any side effects or changes in their health during the study.

The study will last for several months, with regular check-ups to track progress. Participants will have their skin condition assessed at different points in time to see how well the treatment is working. The study aims to provide valuable information on whether efgartigimod PH20 SC can be a beneficial treatment for those living with Systemic Sclerosis.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will confirm your eligibility based on specific criteria, such as age and medical history related to systemic sclerosis.

    You will undergo a series of assessments, including a skin examination to measure the thickness of your skin, and a blood test to check for specific antibodies.

  2. Step 2

    Randomization

    After the initial assessments, you will be randomly assigned to one of two groups. One group will receive the investigational medication, efgartigimod PH20 SC, and the other group will receive a placebo.

    This process is double-blinded, meaning neither you nor the study team will know which group you are in.

  3. Step 3

    Medication administration

    You will receive the assigned medication as a subcutaneous injection, which means it will be injected under the skin using a pre-filled syringe.

    The frequency and dosage of the injections will be determined by the study protocol, and you will be informed about the schedule during your visits.

  4. Step 4

    Follow-up visits

    You will have regular follow-up visits with the study team. These visits will occur at specific intervals to monitor your health and the effects of the medication.

    During these visits, you will undergo various assessments, including skin examinations, blood tests, and questionnaires about your health and any symptoms you may experience.

  5. Step 5

    Midpoint assessment

    At approximately 24 weeks into the study, a detailed assessment will be conducted to evaluate changes in your skin condition and overall health.

    This assessment will help determine the effectiveness of the medication in reducing skin sclerosis.

  6. Step 6

    Final assessment

    At the end of the study period, around 48 weeks, a final assessment will be conducted. This will include a comprehensive evaluation of your skin condition and any changes in your health.

    The study team will also review any side effects or adverse events you may have experienced during the trial.

  7. Step 7

    Study completion

    After the final assessment, your participation in the study will conclude. The study team will provide you with information about the results and any next steps regarding your health care.

    You will have the opportunity to discuss your experience and any concerns with the study team.

Who can join the trial?

7 criteria

  • Must be at least 18 years old and meet the legal age of consent for clinical studies in your area.
  • Must have a diagnosis of either diffuse or limited Systemic Sclerosis (SSc) and meet the 2013 ACR/EULAR classification criteria.
  • Must have a positive result on an antinuclear antibodies (ANA) test with a titer of at least 1:160. This test checks for certain antibodies in your blood.
  • Must have 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. These scores help measure your health and how you feel about it.
  • Must have a modified Rodnan Skin Score (mRSS) between 15 and 35. This score measures the thickness of your skin.
  • If you are anti-RNA polymerase III autoantibody negative, your first non-Raynaud's phenomenon symptom must have appeared less than 5 years before screening. If you are anti-RNA polymerase III autoantibody positive, your first non-Raynaud's phenomenon symptom must have appeared less than 2 years before screening. These antibodies are proteins in your blood that can affect your immune system.
  • Must have an area of skin that is either not affected or only mildly thickened at at least one injection site.

Who cannot join the trial?

10 criteria

  • Patients with any other serious health condition that might interfere with the study.
  • Patients who are pregnant or breastfeeding.
  • Patients who have participated in another clinical trial within the last 30 days.
  • Patients with a history of severe allergic reactions to any of the study medications.
  • Patients with active infections that require treatment.
  • Patients who have received certain medications that might interfere with the study results.
  • Patients with a history of drug or alcohol abuse within the past year.
  • Patients who have had a major surgery within the last 3 months.
  • Patients with unstable or uncontrolled medical conditions.
  • Patients who are unable to comply with the study procedures.
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Investigated drugs

Efgartigimod PH20 SC is a medication being tested in this clinical trial for its potential to help people with systemic sclerosis, a condition that causes hardening and tightening of the skin. This medication is a combination of efgartigimod and rHuPH20, which is designed to be given under the skin. Efgartigimod works by targeting and reducing certain proteins in the body that may be involved in the disease process, potentially leading to an improvement in skin symptoms.

What is already known about the treatment

Efgartigimod PH20 SC – This medication is administered as a subcutaneous injection, meaning it is given under the skin. It is currently being studied in clinical trials for its potential use in treating systemic sclerosis, a condition that causes hardening and tightening of the skin. Efgartigimod PH20 SC works by modulating the immune system to reduce inflammation and skin thickening. It belongs to a class of drugs known as immunomodulators, which help regulate the immune response.

Investigated diseases

Systemic Sclerosis – Systemic Sclerosis is a chronic connective tissue disease characterized by the hardening and tightening of the skin and connective tissues. It progresses with the overproduction and accumulation of collagen in the skin and other organs. This leads to skin thickening, which can limit movement and flexibility. As the disease advances, it may affect internal organs such as the lungs, heart, and kidneys, causing further complications. The progression varies among individuals, with some experiencing only skin involvement, while others may have more widespread organ involvement. The exact cause of Systemic Sclerosis is unknown, but it is believed to involve an autoimmune response.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-514539-67-00Protocol codeARGX-113-2317Estimated enrolment203 patientsSponsorArgenx

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