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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04206553
Other study ID # R668-BP-1902
Secondary ID 2019-003520-20
Status Active, not recruiting
Phase Phase 2/Phase 3
First received
Last updated
Start date October 28, 2020
Est. completion date January 21, 2025

Study information

Verified date April 2024
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 98
Est. completion date January 21, 2025
Est. primary completion date November 11, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 90 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
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.

Locations

Country Name City State
Australia Regeneron Study Site Box Hill Victoria
Australia Regeneron Study Site Kogarah New South Wales
France 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 Cedex
Germany Regeneron Study Site Berlin
Germany Regeneron Study Site Buxtehude
Germany Regeneron Study Site 2 Dresden Saxony
Germany Regeneron Study Site Erlangen
Germany Regeneron Study Site Freiburg
Germany Regeneron Study Site Luebeck Schleswig-Holstein
Germany Regeneron Study site' Magdeburg
Germany Regeneron Study Site Mainz Rheinland-Pfalz
Germany Regeneron Study site Marburg
Germany Regeneron Study Site Muenster North Rhine-Westphal
Germany Regeneron Study Site Munich
Germany Regeneron Study Site Stuttgart
Israel Regeneron study Site Afula
Israel Regeneron study Site Petah Tikva
Israel Regeneron study Site Tel-Aviv
Japan Regeneron Study Site Hirosaki
Japan Regeneron Study Site Ichinomiya
Japan Regeneron Study site Kurume Hukuoka
Japan Regeneron Study Site Osaka
Japan Regeneron Study Site Sapporo
Japan Regeneron Study Site Tokyo
Poland Regeneron Study Site Krakow Malopolskie
Poland Regeneron Study site' Ossy
Poland Regeneron Study site' Wroclaw
Spain Regeneron Study Site Badalona Barcelona
Spain Regeneron Study Site Madrid
Spain Regeneron study Site Madrid
Spain Regeneron study Site Pamplona
Taiwan Regeneron study Site Taipei Zhongzheng District
Taiwan Regeneron study Site Taoyuan City
United States Regeneron study Site Ann Arbor Michigan
United States Regeneron study Site Birmingham Alabama
United States Regeneron Study Site Boston Massachusetts
United States Regeneron Study Site Chapel Hill North Carolina
United States Regeneron study Site Charlottesville Virginia
United States Regeneron Study Site Farmington Connecticut
United States Regeneron Study Site Iowa City Iowa
United States Regeneron Study Site Miami Florida
United States Regeneron Study Site Murray Utah
United States Regeneron study Site Orlando Florida
United States Regeneron Study Site Philadelphia Pennsylvania
United States Regeneron Study Site Portland Oregon
United States Regeneron study Site Providence Rhode Island
United States Regeneron Study Site Redwood City California
United States Regeneron Study Site Scottsdale Arizona

Sponsors (2)

Lead Sponsor Collaborator
Regeneron Pharmaceuticals Sanofi

Countries where clinical trial is conducted

United States,  Australia,  France,  Germany,  Israel,  Japan,  Poland,  Spain,  Taiwan, 

Outcome

Type Measure Description Time frame Safety issue
Other Duration of complete remission while not requiring OCS Baseline to week 36
Other Proportion of patients who do not achieve control of disease activity, who relapse after achieving control of disease activity, or do not achieve complete remission Note: Control of disease activity is defined when new lesions cease to form and existing lesions begin to heal. Baseline to week 36
Other Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% Baseline to week 36
Other Change in autoimmune bullous disease quality of life (ABQOL) ABQOL questionnaire consists of 17 items, which encompass physical burden of the disease, psychiatric effects, and effects on daily life functioning. Each question ranges from 0 to 3 points, with higher scores indicating poorer quality of life. The maximum ABQOL score is 51. Baseline to week 36
Other Change in percent body surface area (BSA) of BP involvement Baseline to week 36
Other Change in BP180 autoantibody (IgG) titers Baseline to week 36
Other Change in BP230 autoantibody (IgG) titers Baseline to week 36
Other Proportion of patients with sustained remission Week 52
Other Total cumulative dose of OCS Baseline to week 52
Other Duration of complete remission while not requiring OCS Up to week 52
Other Proportion of patients who do not achieve control of disease activity, who relapse after achieving control of disease activity, or do not achieve complete remission Up to week 52
Other Percent change in weekly average of daily peak pruritus NRS Baseline to week 52
Other Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS =4 Baseline to week 52
Other Percent change in BPDAI activity score Baseline to week 52
Other Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75% and 90% Baseline to week 52
Other Change in ABQOL Baseline to week 52
Other Change in percent BSA of BP involvement Baseline to week 52
Other Change in BP180 autoantibody (IgG) titers Baseline to week 52
Other Change in BP230 autoantibody (IgG) titers Baseline to week 52
Other Proportion of patients in complete remission and off OCS Week 16
Other Percent change in BPDAI activity score Baseline to week 16
Other Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% Baseline to week 16
Other Percent change in weekly average of daily peak pruritus NRS Baseline to week 16
Other Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS =4 Baseline to week 16
Other Incidence of treatment-emergent adverse events (TEAEs) Baseline to week 64
Other Incidence of treatment-emergent serious adverse events (SAEs) Baseline to week 64
Other Incidence of adverse events of special interest (AESIs) Baseline to week 64
Other Concentrations of functional dupilumab in serum Baseline to week 64
Other Incidence of treatment-emergent anti-drug antibody (ADA) responses and titer Baseline to week 64
Primary Proportion of patients achieving sustained remission Week 36
Secondary Total cumulative dose of oral corticosteroids (OCS) Baseline to week 36
Secondary Percent change in weekly average of daily peak pruritus numerical rating score (NRS) Individual NRS used to rate the intensity of pruritus using an 11-point scale (0 to 10) in which 0 indicates no itch while 10 indicates worst itch possible. Baseline to week 36
Secondary Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS =4 Baseline to week 36
Secondary Percent change in Bullous Pemphigoid Disease Area Index Activity Score (BPDAI) activity score BPDAI activity score is the arithmetic sum of 3 subcomponents: cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. Scores can range from 0 to 360 for BPDAI total activity (maximum 240 for total skin activity and 120 for mucosal activity), with higher scores indicating greater disease activity. Baseline to week 36
Secondary Time to first use of rescue medication Up to week 36
See also
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Completed NCT05649579 - Efficacy and Safety of Dupilumab in Patients With Bullous Pemphigoid
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Completed NCT02883894 - Interest of Dosage of Anti-PB230, Anti-PB180 and Cytokines for Monitoring of Patients Suffering From Bullous Pemphigoid N/A
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