Study of dupilumab effectiveness compared to placebo in adults with bullous pemphigoid

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What is this study about?

This study focuses on adults with Bullous Pemphigoid, a condition that causes large, fluid-filled blisters on the skin. The research evaluates a medication called dupilumab (Dupixent), which is given through injections under the skin, compared to a placebo. Patients in the study will also receive prednisolone, which is a type of corticosteroid medication taken by mouth.

The purpose of this research is to determine if dupilumab is more effective than placebo in helping patients achieve sustained improvement of their condition while being able to stop using oral corticosteroids. The study will last for 52 weeks, during which patients will receive either dupilumab or a matching placebo through regular injections. Throughout the study, doctors will monitor the healing of skin blisters, reduction in itching, and overall improvement in the condition.

During the study, researchers will track various aspects of the disease, including changes in skin symptoms, intensity of itching, quality of life, and the presence of specific antibodies in the blood. They will also monitor the safety of the treatment by recording any side effects that may occur. The total amount of corticosteroids needed during treatment will be measured, as well as how long patients can maintain improvement without requiring oral corticosteroids.

1 Initial treatment phase

You will be randomly assigned to receive either dupilumab (300 mg solution for injection) or a matching placebo through subcutaneous injection

You will also receive oral corticosteroids (prednisolone) as part of your treatment

2 Regular assessments

Your skin condition will be regularly evaluated using the Bullous Pemphigoid Disease Area Index (a measure of disease activity)

Your itching intensity will be measured using a numerical rating scale from 0 to 10

The percentage of your body surface affected by the condition will be monitored

Blood samples will be taken to measure antibody levels related to your condition

3 Quality of life monitoring

You will complete quality of life questionnaires specific to autoimmune skin conditions

Your overall health status will be monitored throughout the study

4 Safety monitoring

Regular health checks will be performed to monitor for any side effects

Blood tests will be conducted to measure the levels of study medication in your system

Any adverse reactions will be recorded and monitored

5 Study completion

The study will continue until January 2025

Your participation will help evaluate if the treatment can achieve sustained improvement of your skin condition without requiring continuous oral corticosteroids

Who Can Join the Study?

  • Age between 18 and 90 years old at the time of screening visit
  • Must have visible signs of bullous pemphigoid including:
    • Hive-like or red patches on skin
    • Fluid-filled blisters
    • Itching
  • Must have confirmed diagnosis of bullous pemphigoid through:
    • Examination of skin tissue sample
    • Special tests of skin immune response
    • Blood tests
  • Must have a BPDAI score of 24 or higher (BPDAI is a tool that measures how severe the skin condition is)
  • Must have significant itching with a score of 4 or higher on a scale that measures itch intensity
  • Must have a Karnofsky performance score of 50% or higher (this measures the person’s ability to perform daily activities)
  • Additional requirements may apply based on study protocol

Who Cannot Join the Study?

  • History of allergic reactions to dupilumab or similar medications
  • Active skin infections that require treatment
  • Other autoimmune conditions affecting the skin
  • Current participation in other clinical trials
  • Pregnancy or breastfeeding
  • Significant liver or kidney problems
  • Uncontrolled high blood pressure or heart disease
  • History of cancer in the past 5 years (except successfully treated skin cancer)
  • Recent use of medications that suppress the immune system (other than those used to treat Bullous Pemphigoid)
  • Active or chronic infections like tuberculosis, HIV, or hepatitis B or C
  • Mental health conditions that could affect participation in the study
  • History of drug or alcohol abuse within the past year
  • Any condition that, in the doctor’s opinion, could make it unsafe to participate in the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Centre Hospitalier Universitaire Rouen Rouen France
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Elbe Kliniken Stade-Buxtehude gGmbH Buxtehude Germany
Hautarztpraxis Dr. Leitz Und Kollegen Stuttgart Germany
Labderm Essence Sp. z o.o. Ozarowice Poland
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie Rzeszow Poland
Cityclinic Przychodnia Lekarsko-Psychologiczna Matusiak sp.p. Wroclaw Poland
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Magdeburg AöR Magdeburg Germany
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Justus-Liebig-Universitaet Giessen Giessen Germany
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Auytbbrauh Ptuawxaa Htvfxxwt Df Pjeee Paris France
Ufedmuifwritthdpxxhct Mwrhchtf Ayj Munster Germany
Htbfpwdl Ulkqcfrsxbgpa Hulowddq Tcpzm y Pjgfbf Icriuohz Cftrnu dkmcttkiibpwyexpf (uyru Badalona Spain

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not recruiting
28.10.2020
Germany Germany
Not recruiting
28.10.2020
Poland Poland
Not recruiting
28.10.2020
Spain Spain
Not recruiting
28.10.2020

Trial locations

Dupilumab is a medication that works by targeting specific parts of the immune system. It helps reduce inflammation in the body. In this trial, it is being tested as a treatment for bullous pemphigoid, which is an autoimmune skin condition that causes large, fluid-filled blisters. The medication is administered through injection under the skin.

Oral Corticosteroids (OCS) are anti-inflammatory medications that help suppress the immune system response. They are commonly used to treat various inflammatory and autoimmune conditions, including bullous pemphigoid. The trial aims to see if patients can achieve remission from their condition without needing these steroids when using dupilumab.

Bullous Pemphigoid – A rare autoimmune skin disorder characterized by the formation of large, fluid-filled blisters (bullae) that develop on the surface of the skin. The condition typically begins with redness and itching of the skin, followed by the appearance of blisters that most commonly occur on the arms, legs, abdomen, and flexor surfaces. The blisters form because the immune system mistakenly attacks proteins that help hold the layers of skin together. The condition primarily affects older adults and tends to develop gradually over weeks or months. The blisters are typically firm, and the skin around them may appear either normal or reddened.

Trial ID:
2024-510745-34-00
Protocol code:
R668-BP-1902
NCT ID:
NCT04206553
Trial Phase:
Therapeutic use (Phase IV)

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