Could an asthma drug tame this brutal blistering disease?
NCT ID NCT04206553
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested whether dupilumab, a drug already used for asthma and eczema, can help people with bullous pemphigoid, a painful blistering skin condition. 106 adults received either dupilumab or a placebo, plus standard steroid treatment. The main goal was to see if more people could achieve long-term remission without needing steroids.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- dupilumab (Dupixent)
- What this could lead to
- If successful, dupilumab could offer a new treatment option for bullous pemphigoid, potentially reducing the need for long-term steroids.
- What could go wrong
- This is a mid-stage trial with only 106 participants. Results may not apply to all patients, and side effects or lack of effectiveness are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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106 people
The number who actually took part.
- Started
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Oct 2020
- Finished
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Jan 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria: * Patients must have characteristic clinical features of bullous pemphigoid (BP) (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits. * Study participants are required to have a confirmed diagnosis of BP based on histopathology, immunopathology, and serology at the baseline visit, as defined in the protocol. * Bullous Pemphigoid Disease Area Index (BPDAI) activity score ≥24 at baseline and screening visits. * Baseline peak pruritus NRS score for maximum itch intensity ≥4 * Karnofsky performance status score ≥50% at the screening visit. Key Exclusion Criteria: * Forms of pemphigoid other than classic BP (eg, Brunsting-Perry cicatricial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or BP with concomitant pemphigus vulgaris) * Patients who are receiving treatments known to cause or exacerbate BP (eg, angiotensin converting enzyme inhibitors, penicillamine, furosemide, phenacetin, dipeptidyl peptidase 4 inhibitor) who have not been on a stable dose of these medications for at least 4 weeks prior to the screening visit * Have ever received treatment with an IL-4 or IL-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab. * Treatment with systemic corticosteroids within 7 days before the baseline visit * Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 7 days before the baseline visit * Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit. * Treatment with BP-directed biologics as follows: * Any cell-depleting agents including but not limited to rituximab: within 12 months before the baseline visit, or until lymphocyte and CD 19+ lymphocyte count returns to normal, whichever is longer * Other biologics (such as IL-5 inhibitors benralizumab or mepolizumab): within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer * Intravenous immunoglobulin within 16 weeks prior to the baseline visit NOTE: Other Protocol Defined Inclusion/Exclusion Criteria Apply
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Regeneron Study Site
Scottsdale, Arizona, 85259, United States
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Regeneron Study Site
Redwood City, California, 94063, United States
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Regeneron Study Site
Farmington, Connecticut, 06030, United States
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Regeneron Study Site
Miami, Florida, 33125, United States
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Regeneron Study Site
Iowa City, Iowa, 52242, United States
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Regeneron Study Site
Boston, Massachusetts, 02116, United States
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Regeneron Study Site
Chapel Hill, North Carolina, 27516, United States
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Regeneron Study Site
Portland, Oregon, 97239, United States
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Regeneron Study Site
Philadelphia, Pennsylvania, 19104, United States
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Regeneron Study Site
Murray, Utah, 84107, United States
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Regeneron Study Site
Kogarah, New South Wales, 2217, Australia
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Regeneron Study Site
Box Hill, Victoria, 3128, Australia
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Regeneron Study Site
Bobigny, 93009, France
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Regeneron Study Site
Bordeaux, 33000, France
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Regeneron Study Site
Lille, 59037, France
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Regeneron Study Site
Nice, 06200, France
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Regeneron Study Site
Paris, 75010, France
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Regeneron Study Site
Rouen, 76031, France
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Regeneron Study Site
Münster, North Rhine-Westphal, 48149, Germany
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Regeneron Study Site
Mainz, Rhineland-Palatinate, 55131, Germany
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Regeneron Study Site
Lübeck, Schleswig-Holstein, 23538, Germany
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Regeneron Study Site
Berlin, 10117, Germany
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Regeneron Study Site
Buxtehude, 21614, Germany
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Regeneron Study Site
Erlangen, 91054, Germany
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Regeneron Study Site
Freiburg im Breisgau, 79104, Germany
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Regeneron Study Site
Munich, 80802, Germany
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Regeneron Study Site
Stuttgart, 70178, Germany
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Regeneron Study Site
Hirosaki, 036-8563, Japan
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Regeneron Study Site
Ichinomiya, 491-8558, Japan
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Regeneron Study Site
Osaka, 545-8586, Japan
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Regeneron Study Site
Sapporo, 060-8648, Japan
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Regeneron Study Site
Tokyo, 160-8582, Japan
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Regeneron Study Site
Krakow, Lesser Poland Voivodeship, 31-147, Poland
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Regeneron Study Site
Badalona, Barcelona, 08916, Spain
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Regeneron Study Site
Madrid, 28034, Spain
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Regeneron Study Site 2
Dresden, Saxony, 01307, Germany
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Regeneron Study site
Marburg, 35043, Germany
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Regeneron Study site
Kurume, Hukuoka, 830-0011, Japan
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Regeneron Study site'
Magdeburg, 39120, Germany
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Regeneron Study site'
Ossy, 42-624, Poland
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Regeneron Study site'
Wroclaw, 50566, Poland
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Regeneron study Site
Birmingham, Alabama, 35233, United States
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Regeneron study Site
Orlando, Florida, 32827, United States
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Regeneron study Site
Ann Arbor, Michigan, 48109-5314, United States
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Regeneron study Site
Providence, Rhode Island, 02908, United States
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Regeneron study Site
Charlottesville, Virginia, 22903, United States
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Regeneron study Site
Afula, 1834111, Israel
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Regeneron study Site
Petah Tikva, 49100, Israel
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Regeneron study Site
Tel Aviv, 6423906, Israel
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Regeneron study Site
Madrid, 28046, Spain
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Regeneron study Site
Pamplona, 31008, Spain
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Regeneron study Site
Taipei, Zhongzheng District, 10002, Taiwan
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Regeneron study Site
Taoyuan City, 33305, Taiwan
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Study reveals bone risks from common skin treatment
- Scientists probe hidden clot risks in autoimmune skin disorders
- New study tests easier treatment for blistering skin disease
- One-Dose hope for blistering skin disease?
- New antibody treatment offers hope for rare blistering skin disease
- Researchers track blistering skin disease to pave way for better treatments