Dupilumab for Bullous Pemphigoid
(LIBERTY-BP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether dupilumab, a monoclonal antibody, is effective and safe for treating bullous pemphigoid, a skin condition that causes painful blisters and mainly affects older adults. The study examines the side effects of dupilumab, its impact on patients' quality of life, and its potential to reduce the need for other medications like oral steroids. People diagnosed with bullous pemphigoid who experience severe itching and skin blisters might be suitable candidates. Participants will receive either dupilumab or a placebo (a treatment with no active medicine) to compare outcomes. As a Phase 2, Phase 3 trial, this research evaluates dupilumab's effectiveness in an initial group and represents the final step before FDA approval, offering participants a chance to contribute to advancing treatment options.
Do I need to stop my current medications to join the trial?
Yes, you may need to stop certain medications before joining the trial. Specifically, you cannot have taken systemic corticosteroids, certain topical treatments, or non-steroidal immunosuppressive drugs shortly before the trial. Check with the trial team for details on your specific medications.
Is there any evidence suggesting that dupilumab is likely to be safe for humans?
Research has shown that dupilumab is generally safe for patients with bullous pemphigoid. Studies identified common side effects such as joint pain, eye inflammation, blurred vision, and viral infections like herpes, occurring in at least 2% of patients.
The FDA has already approved dupilumab for treating bullous pemphigoid, confirming its recognized safety record for this condition. While awareness of possible side effects is important, the overall safety data supports its use. This information should reassure participants interested in joining a trial.12345Why do researchers think this study treatment might be promising for bullous pemphigoid?
Dupilumab is unique because it targets and blocks specific proteins involved in the inflammatory process, primarily interleukin-4 (IL-4) and interleukin-13 (IL-13). Most treatments for bullous pemphigoid, such as corticosteroids and immunosuppressants, work by broadly suppressing the immune system, which can lead to significant side effects. Dupilumab, on the other hand, provides a more targeted approach, potentially reducing inflammation with fewer side effects. Researchers are excited about the possibility of dupilumab offering a safer and more effective treatment option for patients with bullous pemphigoid.
What evidence suggests that dupilumab might be an effective treatment for bullous pemphigoid?
Research has shown that dupilumab, which participants in this trial may receive, holds promise for treating bullous pemphigoid, a condition that causes painful skin blisters. In studies, adults taking dupilumab were five times more likely to experience long-term relief from the disease compared to those taking a placebo. After 36 weeks, 18% of patients using dupilumab with oral corticosteroids achieved remission, while only 6% of those on a placebo did. Dupilumab has been approved in the US as a specific treatment for bullous pemphigoid, highlighting its effectiveness. Overall, dupilumab may provide a safe and effective option for managing this autoimmune skin condition.25678
Who Is on the Research Team?
Clinical Trial Management
Principal Investigator
Regeneron Pharmaceuticals
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive dupilumab or placebo to evaluate efficacy and safety in treating bullous pemphigoid
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Dupilumab is already approved in United States, European Union for the following indications:
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
- Atopic dermatitis
- Asthma
- Chronic rhinosinusitis with nasal polyps
- Eosinophilic esophagitis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Regeneron Pharmaceuticals
Lead Sponsor
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
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
Citations
1.
investor.regeneron.com
investor.regeneron.com/news-releases/news-release-details/dupixentr-dupilumab-late-breaking-positive-pivotal-data-bullousDupixent® (dupilumab) Late-Breaking Positive Pivotal ...
Five times more adults on Dupixent achieved sustained disease remission at 36 weeks compared to placebo; significant reductions were also ...
DUPIXENT® (dupilumab) Efficacy & Safety for Bullous ...
At Week 361. More patients achieved sustained remission with DUPIXENT + oral corticosteroid (OCS) taper vs placebo + OCS taper (18% vs 6%; primary endpoint; ...
Effectiveness of Dupilumab and Omalizumab in Bullous ...
Both biologics seem to be promising treatment adjuvants in the management of BP, with dupilumab showing a descriptive trend toward better outcomes.
Evaluation of Dupilumab in Patients With Bullous ...
This study suggests that dupilumab may be an effective and safe alternative for patients with bullous pemphigoid.
Press Release: Dupixent approved in the US as the only ...
Dupixent approved in the US as the only targeted medicine to treat patients with bullous pemphigoid Approval based on pivotal results ...
NCT04206553 | A Study to Evaluate the Efficacy and ...
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 ...
Dupilumab (Dupixent) to treat bullous pemphigoid
Dupilumab (Dupixent) is a US Food and Drug Administration (FDA)–approved monoclonal antibody treatment for bullous pemphigoid, ...
A Systematic Evaluation of Dupilumab for Bullous ...
The primary outcome was clinical remission, and the secondary outcomes were recurrence and adverse events. Among 96 patients, 71.8% (n = 69/96) ...
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