Dupilumab for Bullous Pemphigoid

(LIBERTY-BP Trial)

Recruiting at 54 trial locations

Overseen By Clinical Trials Administrator

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: Regeneron Pharmaceuticals

Must not be taking: ACE inhibitors, IL-4 antagonists

Disqualifiers: Other pemphigoid forms, Corticosteroids, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

106 Participants Needed

Trial Summary

What is the purpose of this trial?

The main purpose of this study is to investigate whether dupilumab is effective and safe for the treatment of bullous pemphigoid. Dupilumab is a type of drug called a "monoclonal antibody". An antibody is a special kind of protein that the immune (defense) system normally makes to fight bacteria and viruses. Bullous pemphigoid is an autoimmune subepidermal blistering disease, predominately affecting the elderly (typical onset after age 60). The study is looking at several other research questions, including: * Side effects that may be experienced by people taking dupilumab * How dupilumab works in the body and affects the body * How dupilumab affects quality of life * How much dupilumab is present in the blood * To see if dupilumab works to wean the patient off oral corticosteroids

Research Team

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Eligibility Criteria

Adults with bullous pemphigoid (BP), a skin condition, can join this trial if they have symptoms like skin plaques or itching, confirmed BP diagnosis through specific tests, and significant disease activity. They must not have used certain medications recently and should be relatively stable in terms of overall health.

Inclusion Criteria

You have a high score for bullous pemphigoid disease activity at your baseline and screening visits.

My diagnosis of BP was confirmed through specific lab tests.

I have symptoms like itchy blisters or red, swollen patches on my skin.

Exclusion Criteria

I haven't taken any non-steroidal immune drugs in the last 4 weeks.

I have a specific type of skin condition that is not classic bullous pemphigoid.

I haven't used strong skin creams or certain skin medications in the last week.

Treatment Details

Interventions

• Dupilumab

Trial Overview The study is testing whether dupilumab helps patients with BP stop using oral corticosteroids without the disease coming back. It compares dupilumab to a placebo while measuring itch relief, quality of life improvements, antibody levels in blood, drug safety and body's acceptance of the drug.

Participant Groups

Group I: dupilumab Experimental Treatment 2 Interventions

Group II: Matching placebo Experimental Treatment 2 Interventions

Dupilumab is already approved in United States, European Union for the following indications:

Approved in United States as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Approved in European Union as Dupixent for:

• Atopic dermatitis
• Asthma
• Chronic rhinosinusitis with nasal polyps
• Eosinophilic esophagitis

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials

690

Recruited

948,000+

Founded

1988

Headquarters

Tarrytown, USA

Known For

Precision medicine

Top Products

Dupixent, EYLEA, Libtayo, Praluent

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School

Sanofi

Industry Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University