A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid
NCT ID: NCT04206553
Last Updated: 2025-10-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
106 participants
INTERVENTIONAL
2020-10-28
2025-01-05
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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dupilumab
dupilumab
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.
Oral corticosteroids (OCS)
Prednisone or prednisolone per standard of care to obtain control of disease activity.
Matching placebo
Matching Placebo
Matching dupilumab without active substance
Oral corticosteroids (OCS)
Prednisone or prednisolone per standard of care to obtain control of disease activity.
Interventions
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dupilumab
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.
Matching Placebo
Matching dupilumab without active substance
Oral corticosteroids (OCS)
Prednisone or prednisolone per standard of care to obtain control of disease activity.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
Exclusion Criteria
* 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
18 Years
90 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Regeneron study Site
Birmingham, Alabama, United States
Regeneron Study Site
Scottsdale, Arizona, United States
Regeneron Study Site
Redwood City, California, United States
Regeneron Study Site
Farmington, Connecticut, United States
Regeneron Study Site
Miami, Florida, United States
Regeneron study Site
Orlando, Florida, United States
Regeneron Study Site
Iowa City, Iowa, United States
Regeneron Study Site
Boston, Massachusetts, United States
Regeneron study Site
Ann Arbor, Michigan, United States
Regeneron Study Site
Chapel Hill, North Carolina, United States
Regeneron Study Site
Portland, Oregon, United States
Regeneron Study Site
Philadelphia, Pennsylvania, United States
Regeneron study Site
Providence, Rhode Island, United States
Regeneron Study Site
Murray, Utah, United States
Regeneron study Site
Charlottesville, Virginia, United States
Regeneron Study Site
Kogarah, New South Wales, Australia
Regeneron Study Site
Box Hill, Victoria, Australia
Regeneron Study Site
Bobigny, , France
Regeneron Study Site
Bordeaux, , France
Regeneron Study Site
Lille, , France
Regeneron Study Site
Nice, , France
Regeneron Study Site
Paris, , France
Regeneron Study Site
Rouen, , France
Regeneron Study Site
Münster, North Rhine-Westphal, Germany
Regeneron Study Site
Mainz, Rhineland-Palatinate, Germany
Regeneron Study Site 2
Dresden, Saxony, Germany
Regeneron Study Site
Lübeck, Schleswig-Holstein, Germany
Regeneron Study Site
Berlin, , Germany
Regeneron Study Site
Buxtehude, , Germany
Regeneron Study Site
Erlangen, , Germany
Regeneron Study Site
Freiburg im Breisgau, , Germany
Regeneron Study site'
Magdeburg, , Germany
Regeneron Study site
Marburg, , Germany
Regeneron Study Site
Munich, , Germany
Regeneron Study Site
Stuttgart, , Germany
Regeneron study Site
Afula, , Israel
Regeneron study Site
Petah Tikva, , Israel
Regeneron study Site
Tel Aviv, , Israel
Regeneron Study site
Kurume, Hukuoka, Japan
Regeneron Study Site
Hirosaki, , Japan
Regeneron Study Site
Ichinomiya, , Japan
Regeneron Study Site
Osaka, , Japan
Regeneron Study Site
Sapporo, , Japan
Regeneron Study Site
Tokyo, , Japan
Regeneron Study Site
Krakow, Lesser Poland Voivodeship, Poland
Regeneron Study site'
Ossy, , Poland
Regeneron Study site'
Wroclaw, , Poland
Regeneron Study Site
Badalona, Barcelona, Spain
Regeneron Study Site
Madrid, , Spain
Regeneron study Site
Madrid, , Spain
Regeneron study Site
Pamplona, , Spain
Regeneron study Site
Taipei, Zhongzheng District, Taiwan
Regeneron study Site
Taoyuan, , Taiwan
Countries
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References
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Murrell DF, Joly P, Werth VP, Ujiie H, Worm M, Mangold AR, Avetisova E, Maloney J, Laws E, Mortensen E, Dubost-Brama A, Shabbir A. Study Design of a Phase 2/3 Randomized Controlled Trial of Dupilumab in Adults with Bullous Pemphigoid: LIBERTY-BP ADEPT. Adv Ther. 2024 Jul;41(7):2991-3002. doi: 10.1007/s12325-024-02810-3. Epub 2024 Mar 5.
Other Identifiers
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2019-003520-20
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2024-510745-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
R668-BP-1902
Identifier Type: -
Identifier Source: org_study_id
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