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Study on Long-term Safety and Effects of Efgartigimod PH20 SC for Adults with Bullous Pemphigoid

Fast replyInvestigationalNo placebo
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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 called Bullous Pemphigoid, which is a rare skin disorder that causes large, fluid-filled blisters. The study is testing a treatment called efgartigimod PH20 SC, which is given as a solution for injection under the skin. The purpose of the study is to evaluate the long-term safety and how well people tolerate this treatment.

Participants in the study will receive the treatment over a period of time, and researchers will monitor them to see how their bodies respond. The study will look at how often and how severe any side effects are, as well as how many participants stop the treatment due to safety concerns. The study will also assess how well the treatment works in managing the symptoms of Bullous Pemphigoid over time.

In addition to the main treatment, some participants may receive a substance called placebo, which looks like the treatment but does not contain the active ingredient. This helps researchers compare the effects of the actual treatment with no treatment. The study aims to provide valuable information about the potential benefits and risks of using efgartigimod PH20 SC for people with Bullous Pemphigoid.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, ensure that the week 36 visit of ARGX-113-2009 has been completed. This is a requirement to participate in the current study.

    Provide signed informed consent, confirming understanding of the study requirements and agreeing to comply with them.

  2. Step 2

    Contraceptive measures

    If male, use a condom as a method of contraception from the time of signing the informed consent form until the last dose of the investigational medicinal product (IMP).

    If female and of childbearing potential, ensure a negative urine pregnancy test at baseline before receiving the IMP. Use one of the contraception methods described in the protocol from signing the informed consent form until the last dose of IMP.

  3. Step 3

    Treatment administration

    Receive the medication efgartigimod PH20 SC through a subcutaneous injection. This means the medication is injected under the skin.

    The study aims to evaluate the long-term safety and tolerability of this treatment in participants with bullous pemphigoid.

  4. Step 4

    Monitoring and assessments

    Throughout the study, the incidence and severity of any treatment-emergent adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESIs) will be monitored.

    The rate of treatment discontinuation due to safety concerns will also be assessed.

  5. Step 5

    Study duration

    The estimated end date of the study is September 9, 2025. Participation will continue until this date unless otherwise specified by the study protocol.

Who can join the trial?

4 criteria

  • The patient must have completed the week 36 visit of the study identified as ARGX-113-2009.
  • The patient must be capable of providing signed informed consent, which means they understand the study and agree to participate.
  • The patient must agree to use contraceptive measures as required by local regulations:
    • Male participants: Must use a condom from the time they sign the informed consent form until the last dose of the study medication.
    • Women of childbearing potential: Must have a negative urine pregnancy test before starting the study medication and use a specified method of contraception from signing the informed consent form until the last dose of the study medication.

Who cannot join the trial?

4 criteria

  • Patients who do not have a confirmed diagnosis of Bullous Pemphigoid cannot participate.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
  • Patients who do not meet other specific health criteria set by the study cannot participate.
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Investigated drugs

Efgartigimod PH20 SC is a medication being studied for its long-term safety and effectiveness in treating a skin condition called bullous pemphigoid. This condition causes painful blisters on the skin. Efgartigimod PH20 SC works by targeting and reducing certain proteins in the body that are involved in the immune system's attack on the skin, which helps to decrease the formation of blisters and improve symptoms. The medication is administered under the skin, and the study aims to see how well patients tolerate it over a longer period.

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 to evaluate its long-term safety and effectiveness for treating bullous pemphigoid, a rare skin condition. Efgartigimod works by targeting and reducing specific antibodies in the body that contribute to the disease, helping to alleviate symptoms. It is classified as an immunomodulatory drug, which means it helps to regulate the immune system's activity.

Investigated diseases

Bullous Pemphigoid – Bullous Pemphigoid is a chronic autoimmune skin disorder characterized by large, fluid-filled blisters. These blisters typically form on areas of the skin that often flex, such as the lower abdomen, upper thighs, or armpits. The disease occurs when the immune system mistakenly attacks a thin layer of tissue below the outer layer of skin, leading to inflammation and blister formation. The blisters are usually tense and do not easily rupture, and they may be accompanied by itching or a rash. Over time, the blisters may heal and leave behind dark spots or scars. The condition can fluctuate, with periods of flare-ups and remission.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515832-59-00Protocol codeARGX-113-2010Estimated enrolment106 patientsSponsorArgenx

sourced from the EU Clinical Trials Register and site verification

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

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