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Study on Efgartigimod Alfa and Prednisone for Adults with Bullous Pemphigoid

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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 skin condition called bullous pemphigoid, which causes large, fluid-filled blisters on areas of the skin that often itch. The study is testing a new treatment called efgartigimod PH20 SC, which is given as an injection under the skin. The purpose of the study is to see if this treatment can help people with bullous pemphigoid achieve a long-lasting improvement in their condition.

Participants in the study will receive either the new treatment or a placebo, which looks like the treatment but does not contain any active medicine. The study will last for about 36 weeks, during which time participants will be monitored to see how well the treatment works and to check for any side effects. The study will also look at how the treatment affects the need for other medications, like oral corticosteroids, which are often used to manage bullous pemphigoid.

Throughout the study, participants will have regular check-ups to assess their skin condition and overall health. The goal is to determine if efgartigimod PH20 SC can help control the symptoms of bullous pemphigoid and reduce the need for other treatments. This research could lead to new options for managing this challenging skin condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes a review of medical history and a physical examination.

    A pregnancy test is required for women of childbearing potential to ensure safety before starting the trial.

  2. Step 2

    Baseline measurements

    Baseline measurements are taken to establish a starting point for the study. This includes recording the severity of bullous pemphigoid symptoms and other relevant health indicators.

  3. Step 3

    Medication administration

    Participants receive either efgartigimod PH20 SC or a placebo through a subcutaneous injection. The frequency and dosage are determined by the study protocol.

    In addition, prednisone, an oral medication, may be administered as part of the treatment plan. The dosage and frequency depend on individual needs and study requirements.

  4. Step 4

    Ongoing monitoring

    Regular follow-up visits are scheduled to monitor health status and response to treatment. This includes physical examinations and symptom assessments.

    Participants are required to report any side effects or changes in health during these visits.

  5. Step 5

    Evaluation of treatment efficacy

    The effectiveness of the treatment is evaluated by measuring the proportion of participants achieving complete remission without oral corticosteroids for at least 8 weeks by week 36.

    Additional assessments include changes in symptom severity and quality of life scores.

  6. Step 6

    Completion of study

    The study concludes with a final assessment to evaluate overall health and treatment outcomes.

    Participants may be asked to provide feedback on their experience during the trial.

Who can join the trial?

4 criteria

  • The participant must be willing and able to understand what the study requires, give written permission to join, and follow the study's rules and procedures.
  • The participant can be male or female and must be old enough to legally give consent in their area at the time they sign the consent form.
  • The participant must show clinical signs of **Bullous Pemphigoid (BP)**, which is a skin condition.
  • The participant must agree to use birth control methods that follow local laws. Women who can have children must have a negative blood pregnancy test at the start of the study and a negative urine pregnancy test before receiving the study medication.

Who cannot join the trial?

10 criteria

  • Having any other serious health condition that could interfere with the study.
  • Being pregnant or breastfeeding.
  • Having a history of drug or alcohol abuse.
  • Having participated in another clinical trial recently.
  • Having an allergy to the study medication or its ingredients.
  • Having a condition that affects the immune system, which is the body's defense against illness.
  • Having a recent infection that required treatment with antibiotics.
  • Having received a vaccine within a certain time before the study.
  • Having a history of cancer, except for certain types that have been treated successfully.
  • Having a blood disorder, which affects the way blood works in the body.
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Investigated drugs

Efgartigimod PH20 SC is a medication being studied for its effectiveness in treating bullous pemphigoid, a skin condition that causes large, fluid-filled blisters. This medication is designed to help reduce the symptoms of the disease and achieve sustained remission, meaning that the symptoms are reduced or disappear for a period of time. The study aims to determine how well this medication works and how safe it is for patients with this condition.

What is already known about the treatment

Efgartigimod PH20 SC – This medication is administered subcutaneously, meaning it is injected under the skin. It is currently being studied in clinical trials for its effectiveness and safety in treating bullous pemphigoid, a rare skin condition. The main therapeutic indication for efgartigimod PH20 SC is to help achieve sustained remission in patients with this condition. At the molecular level, it works by modulating the immune system to reduce the production of antibodies that contribute to the disease. It is classified pharmacologically as an immunomodulatory agent.

Investigated diseases

Bullous Pemphigoid – Bullous pemphigoid is a rare skin condition characterized by large, fluid-filled blisters that develop on areas of the skin that often flex, such as the lower abdomen, upper thighs, or armpits. It primarily affects older adults and is caused by an autoimmune response where the body's immune system mistakenly attacks the skin's basement membrane, leading to blister formation. The blisters are usually tense and do not rupture easily, and they may be accompanied by itching or redness. The condition can vary in severity, with some individuals experiencing only mild symptoms, while others may have widespread blistering. Over time, the blisters may heal, but new ones can continue to form, leading to a chronic course.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IVTrial ID2023-508645-40-00Protocol codeARGX-113-2009Estimated enrolment157 patientsSponsorArgenx

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