Bullous pemphigoid (BP) MedDRA version: 20.0 Level: PT Classification code 10034277 Term: Pemphigoid System Organ Class: 10040785 - Skin and subcutaneous tissue disorders
Conditions
Interventions
Trade Name: Dupixent
Product Name: dupilumab
Pharmaceutical Form: Solution for injection
INN or Proposed INN: dupilumab
Current Sponsor code: REGN668
Other descriptive name: DUPILUMAB
Concentration un
Sponsors
Regeneron Pharmaceuticals, Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients must have clinical features of BP (eg, urticarial or eczematous or erythematous plaques, bullae, pruritus) at the screening and baseline visits. 2. Study participants are required to have histological and serological confirmation of BP by the baseline visit. 3. Bullous Pemphigoid Disease Area Index (BPDAI) activity score =24 at baseline and screening visits. 4. Baseline peak pruritus NRS score for maximum itch intensity =4 5. Male or female, age 18 to 90 at the screening visit 6. Karnofsky performance status score =50% at the screening visit. NOTE: Other protocol defined inclusion criteria apply Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 16 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 64
Exclusion criteria
Exclusion criteria: 1. Forms of pemphigoid other than classic BP (eg, mucous membrane-dominant BP, Brunsting Perry cicatrial pemphigoid, anti-p200 pemphigoid, epidermolysis bullosa acquisita, or BP with concomitant pemphigus vulgaris) 2. 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 3. Have ever received treatment with an IL-4 or IL-13 antagonist such as dupilumab, tralokinumab, or lebrikizumab. 4. Treatment with systemic corticosteroids within 2 weeks before the baseline visit 5. Treatment with topical corticosteroids of medium potency or higher, topical calcineurin inhibitor, or topical crisaborole within 1 week before the baseline visit 6. Treatment with non-steroidal immunosuppressive/immunomodulating drug(s) (eg, mycophenolate mofetil, azathioprine, or methotrexate) within 4 weeks before the baseline visit. 7. Treatment with BP-directed biologics as follows: a. 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 b. Other biologics: within 5 half-lives (if known) or 16 weeks prior to the baseline visit, whichever is longer c. Intravenous immunoglobulin within 16 weeks prior to the baseline visit NOTE: Other protocol defined exclusion criteria apply
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of the study is to demonstrate that dupilumab is superior to placebo in achieving sustained remission off oral corticosteroids (OCS) in patients with bullous pemphigoid (BP).;Secondary Objective: -To evaluate the OCS-sparing effects of dupilumab in patients with BP -To evaluate the effect of dupilumab on itch in patients with BP -To evaluate the effects of dupilumab on health-related quality of life measures in patients with BP -To evaluate the effect of dupilumab in circulating BP180 and BP230 autoantibody titers -To assess the safety and tolerability of dupilumab administered to patients with BP -To characterize the trough concentrations of functional dupilumab over time following administration of dupilumab in patients with BP -To assess the immunogenicity of dupilumab in patients with BP over time;Primary end point(s): Proportion of patients achieving sustained remission at week 36.;Timepoint(s) of evaluation of this end point: Week 36 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The key secondary efficacy endpoints are: (1) Total cumulative dose of OCS from baseline to week 36 (2) Percent change in weekly average of daily peak pruritus numerical rating score (NRS) from baseline to week 36 (3) Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS =4 from baseline to week 36 (4) Percent change in BPDAI activity score from baseline to week 36 Other secondary endpoints for efficacy: (5) Duration of complete remission while not requiring OCS (up to week 36) (6) Proportion of patients who do not achieve control of disease activity or who relapse after achieving control of disease activity (Note: control of disease activity is defined when new lesions cease to form and existing lesions begin to heal) (7) Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% from baseline to week 36 (8) Change in autoimmune bullous disease quality of life (ABQOL) from baseline to week 36 (9) Change from baseline to week 36 in percent body surface area (BSA) of BP involvement (10) Change in BP180 and BP230 autoantibody (IgG) titers from baseline to week 36 (11) Proportion of patients in complete remission and off OCS at week 16 (12) Percent change in BPDAI activity score from baseline to week 16 (13) Proportion of patients who achieve a reduction in BPDAI activity score of at least 50%, 75%, and 90% from baseline to week 16 (14) Percent change in weekly average of daily peak pruritus NRS from baseline to week 16 (15) Proportion of patients with improvement (reduction) of weekly average of daily peak pruritus NRS =4 from baseline to week 16 Other secondary endpoints for safety: (16) Incidence of treatment-emergent adverse events (TEAEs) from baseline through end of treatment (up to week 36) (17) Incidence of treatment-emergent serious adverse events (SAEs) from baseline through the end of treatment (up to week 36) (18) Incidence of adverse events of speci | — |
Countries
Australia, France, Germany, Japan, Poland, Spain, United States
Contacts
Public ContactClinical Trial Information
Regeneron Pharmaceuticals, Inc.
Outcome results
None listed