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NCT04206553

PHASE2/PHASE3

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

Sponsor: Regeneron Pharmaceuticals

View on ClinicalTrials.gov

Summary

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

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

106

Start Date

2020-10-28

Completion Date

2025-01-05

Last Updated

2026-06-18

Healthy Volunteers

Conditions

Bullous Pemphigoid

Interventions

DRUG

dupilumab

Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.

DRUG

Matching Placebo

Matching dupilumab without active substance

DRUG

Oral corticosteroids (OCS)

Prednisone or prednisolone per standard of care to obtain control of disease activity.

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

Locations (53)

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 City, Taiwan

Clinical Research Directory

A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (53)