Not recruitingRare disease

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

Fast replyRegistered drugNo placebo

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What is this trial about?

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

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.

The research process

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

Step 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
Step 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
Step 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
Step 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
Step 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 trial?

11 criteria

Age between 18 and 90 years old at the time of screening visit
check
Must have visible signs of bullous pemphigoid including:
- Hive-like or red patches on skin
- Fluid-filled blisters
- Itching
- check
  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 trial?

13 criteria

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

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Assistance Publique Hopitaux De Paris
Paris, France
Verified
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz
Mainz, Germany
Responsive
Uniwersytecki Szpital Kliniczny Im.Fryderyka Chopina W Rzeszowie
Rzeszow, Poland

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Dupilumab - A monoclonal antibody medication administered through subcutaneous injection, primarily used in treating various inflammatory conditions including bullous pemphigoid, a rare autoimmune blistering skin disease. This biological agent works by blocking specific proteins called interleukins (IL-4 and IL-13) that are involved in the inflammatory response, thereby reducing immune system overactivity that causes skin blistering and inflammation. Currently well-established in medical literature and approved by regulatory authorities, dupilumab belongs to the class of targeted immunomodulatory therapies and represents a modern approach to treating autoimmune conditions, offering an alternative to traditional oral corticosteroids (OCS) in the management of bullous pemphigoid.

Investigated diseases

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.