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

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified January 2026 by Regeneron Pharmaceuticals
Sponsor
Regeneron Pharmaceuticals
Information Provided by (Responsible Party)
Regeneron Pharmaceuticals
Clinicaltrials.gov Identifier
NCT04206553
Other Study ID Numbers:
R668-BP-1902
First Submitted
December 17, 2019
First Posted
December 19, 2019
Results First Posted
January 1, 2026
Last Update Posted
March 5, 2026
Last Verified
January 2026

ClinicalTrials.gov processed this data on February 2026Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Bullous Pemphigoid
Drug: dupilumabDrug: Matching Placebo

Study Design

Study TypeInterventional
Actual Enrollment106 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingQuadruple
Primary PurposeTreatment
Official TitleA Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult Patients With Bullous Pemphigoid
Study Start DateOctober 27, 2020
Actual Primary Completion DateJuly 11, 2024
Actual Study Completion DateJanuary 4, 2025

Groups and Cohorts

Group/CohortIntervention/Treatment
dupilumab
Drug: dupilumab
Loading dose administered subcutaneous (SC), followed by SC once every 2 weeks (Q2W) dosing.
Matching placebo
Drug: Matching Placebo
Matching dupilumab without active substance

Outcome Measures

Primary Outcome Measures
  1. Percent of Participants Achieving Sustained Remission at Week 36
    Sustained remission at week 36, defined as: (1) Complete remission (absence of new lesions \& epithelialization of old lesions) \& off oral corticosteroids (OCS) no later than week 16 \& (2) Absence of disease relapse (appearance of ≥3 new lesions a month \[blisters, eczematous lesions, or urticarial plaques\] or at least 1 large eczematous lesion or urticarial plaque that does not heal within 1 week) after completion of OCS taper, no later than week 16, to week 36 \& (3) Absence of need for rescue therapy during 36 weeks (rescue therapy includes increase of OCS dose during the taper, re-initiation of OCS after completion of the OCS taper, or initiation of any BP-directed therapy). Participants with missing sustained remission data at week 36 due to discontinuation due to lack of efficacy, treatment-related AE, or death were considered non-responders \& those with missing data due to other reasons were handled using multiple imputation.
Secondary Outcome Measures
  1. Total Cumulative Dose of Oral Corticosteroids (OCS) From Baseline to Week 36
    All participants in both treatment groups were started on OCS at randomization (day 1) with taper beginning no later than week 6 with the objective to taper off by week 16. OCS could be used as rescue treatment for loss of disease control/ disease relapse during the study. Days after non-OCS systemic rescue treatment use were imputed by the worst observation carried forward (WOCF) method (i.e., the highest daily OCS dose prior to any non-OCS systemic rescue treatment use). Missing data after study discontinuation were imputed with the average daily OCS dose among week 36 completers in each treatment group.
  2. Percent Change in Weekly Average of Daily Peak Pruritus Numerical Rating Scale (NRS) Score From Baseline to Week 36
    Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  3. Percent of Participants With Improvement (Reduction) of Weekly Average of Daily Peak Pruritus NRS ≥4 From Baseline to Week 36
    Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the weekly average of daily peak pruritus NRS.
  4. Percent Change in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score From Baseline to Week 36
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  5. Time to First Use of Rescue Medication Up to Week 36
    Participants were considered to have used rescue treatment at the time of discontinuation from the study due to lack of efficacy, treatment-related AE, or death. Participants were censored at the time of discontinuation from the study due to other reasons. Restricted mean event time and corresponding standard error (SE) are based on the Kaplan-Meier method. The restricted mean event time was calculated up to study day 253 (i.e., week 36).
  6. Duration of Complete Remission While Not Requiring OCS Up to Week 36
    Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants were considered as not achieving complete remission after rescue treatment use. Participants with missing assessment of complete remission caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered as not achieving complete remission. Participants with missing assessment of complete remission due to other reasons were imputed using multiple imputation.
  7. Percent of Participants Who Did Not Achieve Control of Disease Activity Before Week 36
    Control of disease activity was defined as absence of new lesions and existing lesions beginning to heal. Participants who achieved initial control of disease activity after rescue treatment use were considered to not have achieved control of disease activity before week 36. Participants whose response status could not be determined due to missing data were considered to not have achieved control of disease activity before week 36.
  8. Percent of Participants Who Relapsed After Achieving Control of Disease Activity Up to Week 36
    Relapse was defined as the appearance of 3 or more new lesions a month (blisters, eczematous lesions, or urticarial plaques) or at least 1 large (\>10 centimeters \[cm\] diameter) eczematous lesion or urticarial plaque that does not heal within 1 week. Control of disease activity was defined as absence of new lesions and existing lesions beginning to heal. Participants who used rescue treatment were considered to have relapsed after achieving control of disease activity. Participants whose response status could not be determined due to missing data were considered to have relapsed after achieving control of disease activity.
  9. Percent of Participants Who Did Not Achieve Complete Remission Before Week 36
    Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants who achieved initial complete remission after rescue treatment use were considered to not have achieved complete remission before week 36. Participants whose response status could not be determined due to missing data were considered to not have achieved complete remission before week 36.
  10. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥50% From Baseline to Week 36
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  11. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥75% From Baseline to Week 36
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  12. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥90% From Baseline to Week 36
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 36 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  13. Change in Autoimmune Bullous Disease Quality of Life (ABQOL) Score From Baseline to Week 36
    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. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  14. Change in Percent Body Surface Area (BSA) of BP Involvement From Baseline to Week 36
    Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  15. Change in BP180 Immunoglobulin G (IgG) Autoantibody Titer From Baseline to Week 36
    Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  16. Change in BP230 IgG Autoantibody Titer From Baseline to Week 36
    Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  17. Percent of Participants Achieving Sustained Remission at Week 52
    Sustained remission at week 52, defined as: (1) Complete remission (absence of new lesions \& epithelialization of old lesions) \& off OCS no later than week 16 \& (2) Absence of disease relapse (appearance of ≥3 new lesions a month \[blisters, eczematous lesions, or urticarial plaques\] or at least 1 large eczematous lesion or urticarial plaque that does not heal within 1 week) after completion of OCS taper, no later than week 16, to week 52 \& (3) Absence of need for rescue therapy during 52 weeks (rescue therapy includes increase of OCS dose during the taper, re-initiation of OCS after completion of the OCS taper, or initiation of any BP-directed therapy). Participants with missing sustained remission data at week 52 due to discontinuation due to lack of efficacy, treatment-related AE, or death were considered non-responders \& those with missing data due to other reasons were handled using multiple imputation.
  18. Total Cumulative Dose of OCS From Baseline to Week 52
    All participants in both treatment groups were started on OCS at randomization (day 1) with taper beginning no later than week 6 with the objective to taper off by week 16. OCS could be used as rescue treatment for loss of disease control/ disease relapse during the study. Days after non-OCS systemic rescue treatment use were imputed by the WOCF method (i.e., the highest daily OCS dose prior to any non-OCS systemic rescue treatment use). Missing data after study discontinuation were imputed with the average daily OCS dose among week 52 completers in each treatment group.
  19. Duration of Complete Remission While Not Requiring OCS Up to Week 52
    Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants were considered as not achieving complete remission after rescue treatment use. Participants with missing assessment of complete remission caused by discontinuation from the study before week 52 due to lack of efficacy, treatment-related AE, or death were considered as not achieving complete remission. Participants with missing assessment of complete remission due to other reasons were imputed using multiple imputation.
  20. Percent of Participants Who Did Not Achieve Control of Disease Activity Before Week 52
    Control of disease activity was defined as absence of new lesions and existing lesions beginning to heal. Participants who achieved initial control of disease activity after rescue treatment use were considered to not have achieved control of disease activity before week 52. Participants whose response status could not be determined due to missing data were considered to not have achieved control of disease activity before week 52.
  21. Percent of Participants Who Relapsed After Achieving Control of Disease Activity Up to Week 52
    Relapse was defined as the appearance of 3 or more new lesions a month (blisters, eczematous lesions, or urticarial plaques) or at least 1 large (\>10 cm diameter) eczematous lesion or urticarial plaque that does not heal within 1 week. Control of disease activity was defined as absence of new lesions and existing lesions beginning to heal. Participants who used rescue treatment were considered to have relapsed after achieving control of disease activity. Participants whose response status could not be determined due to missing data were considered to have relapsed after achieving control of disease activity.
  22. Percent of Participants Who Did Not Achieve Complete Remission Before Week 52
    Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants who achieved initial complete remission after rescue treatment use were considered to not have achieved complete remission before week 52. Participants whose response status could not be determined due to missing data were considered to not have achieved complete remission before week 52.
  23. Percent Change in Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 52
    Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 52. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  24. Percent of Participants With Improvement (Reduction) of Weekly Average of Daily Peak Pruritus NRS ≥4 From Baseline to Week 52
    Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 52 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the weekly average of daily peak pruritus NRS.
  25. Percent Change in BPDAI Activity Score From Baseline to Week 52
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 52. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  26. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥50% From Baseline to Week 52
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 52 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  27. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥75% From Baseline to Week 52
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 52 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  28. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥90% From Baseline to Week 52
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 52 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  29. Change in ABQOL Score From Baseline to Week 52
    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. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 52. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  30. Change in Percent BSA of BP Involvement From Baseline to Week 52
    Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 52. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  31. Change in BP180 IgG Autoantibody Titer From Baseline to Week 52
    Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 52. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  32. Change in BP230 IgG Autoantibody Titer From Baseline to Week 52
    Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 52. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  33. Percent of Participants in Complete Remission and Off OCS No Later Than Week 16
    Complete remission was defined as absence of new lesions and epithelialization of old lesions. Participants were considered non-responders after rescue treatment use. Participants with missing assessment of complete remission caused by discontinuation from the study before week 16 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Participants with missing assessment of complete remission before week 16 due to other reasons were imputed using multiple imputation.
  34. Percent Change in BPDAI Activity Score From Baseline to Week 16
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  35. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥50% From Baseline to Week 16
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 16 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  36. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥75% From Baseline to Week 16
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 16 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  37. Percent of Participants Achieving a Reduction in BPDAI Activity Score of ≥90% From Baseline to Week 16
    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. Participants were required to have a BPDAI activity score of ≥24 at the screening and baseline visits for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 16 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the BPDAI activity score.
  38. Percent Change in Weekly Average of Daily Peak Pruritus NRS From Baseline to Week 16
    Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Values after first rescue treatment were set to missing and were imputed with the worst value from the closest visit on or prior to rescue medication use and afterwards up to and including week 36. Missing values caused by discontinuation from the study due to lack of efficacy, treatment-related AE, or death were imputed by the WOCF method. Missing values due to other reasons were imputed by multiple imputation.
  39. Percent of Participants With Improvement (Reduction) of Weekly Average of Daily Peak Pruritus NRS ≥4 From Baseline to Week 16
    Peak pruritus NRS was used by participants to rate the intensity of pruritus during the past 24 hours, with 0 indicating no itch and 10 indicating worst itch possible. Participants were required to have a baseline peak pruritus NRS maximum intensity average of ≥4 during the 7 days prior to randomization for eligibility. Participants were considered non-responders after rescue treatment use. Participants with missing values caused by discontinuation from the study before week 16 due to lack of efficacy, treatment-related AE, or death were considered non-responders. Missing values due to other reasons were imputed using multiple imputation of the continuous data of the weekly average of daily peak pruritus NRS.
  40. Number of Participants With At Least One Treatment-emergent Adverse Event (TEAE) Through Week 52
  41. Number of Participants With At Least One Serious TEAE Through Week 52
  42. Number of Participants With At Least One TE Adverse Event of Special Interest (AESI) Through Week 52
  43. Number of Participants With At Least One TEAE Through Week 64
  44. Number of Participants With At Least One Serious TEAE Through Week 64
  45. Number of Participants With At Least One TE AESI Through Week 64
  46. Concentrations of Functional Dupilumab in Serum
  47. Number of Participants With TE Anti-drug Antibody (ADA) Response Per Maximum Titer Category

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
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

Contacts and Locations

Sponsors and CollaboratorsRegeneron Pharmaceuticals
Locations
Regeneron study Site | Birmingham Alabama, United States, 35233Regeneron Study Site | Scottsdale Arizona, United States, 85259Regeneron Study Site | Redwood City California, United States, 94063Regeneron Study Site | Farmington Connecticut, United States, 06030Regeneron Study Site | Miami Florida, United States, 33125Regeneron study Site | Orlando Florida, United States, 32827Regeneron Study Site | Iowa City Iowa, United States, 52242Regeneron Study Site | Boston Massachusetts, United States, 02116Regeneron study Site | Ann Arbor Michigan, United States, 48109-5314Regeneron Study Site | Chapel Hill North Carolina, United States, 27516Regeneron Study Site | Portland Oregon, United States, 97239Regeneron Study Site | Philadelphia Pennsylvania, United States, 19104Regeneron study Site | Providence Rhode Island, United States, 02908Regeneron Study Site | Murray Utah, United States, 84107Regeneron study Site | Charlottesville Virginia, United States, 22903Regeneron Study Site | Kogarah New South Wales, Australia, 2217Regeneron Study Site | Box Hill Victoria, Australia, 3128Regeneron Study Site | Bobigny , France, 93009Regeneron Study Site | Bordeaux , France, 33000Regeneron Study Site | Lille , France, 59037Regeneron Study Site | Nice , France, 06200Regeneron Study Site | Paris , France, 75010Regeneron Study Site | Rouen , France, 76031Regeneron Study Site | Münster North Rhine-Westphal, Germany, 48149Regeneron Study Site | Mainz Rhineland-Palatinate, Germany, 55131Regeneron Study Site 2 | Dresden Saxony, Germany, 01307Regeneron Study Site | Lübeck Schleswig-Holstein, Germany, 23538Regeneron Study Site | Berlin , Germany, 10117Regeneron Study Site | Buxtehude , Germany, 21614Regeneron Study Site | Erlangen , Germany, 91054Regeneron Study Site | Freiburg im Breisgau , Germany, 79104Regeneron Study site' | Magdeburg , Germany, 39120Regeneron Study site | Marburg , Germany, 35043Regeneron Study Site | Munich , Germany, 80802Regeneron Study Site | Stuttgart , Germany, 70178Regeneron study Site | Afula , Israel, 1834111Regeneron study Site | Petah Tikva , Israel, 49100Regeneron study Site | Tel Aviv , Israel, 6423906Regeneron Study site | Kurume Hukuoka, Japan, 830-0011Regeneron Study Site | Hirosaki , Japan, 036-8563Regeneron Study Site | Ichinomiya , Japan, 491-8558Regeneron Study Site | Osaka , Japan, 545-8586Regeneron Study Site | Sapporo , Japan, 060-8648Regeneron Study Site | Tokyo , Japan, 160-8582Regeneron Study Site | Krakow Lesser Poland Voivodeship, Poland, 31-147Regeneron Study site' | Ossy , Poland, 42-624Regeneron Study site' | Wroclaw , Poland, 50566Regeneron Study Site | Badalona Barcelona, Spain, 08916Regeneron Study Site | Madrid , Spain, 28034Regeneron study Site | Madrid , Spain, 28046Regeneron study Site | Pamplona , Spain, 31008Regeneron study Site | Taipei Zhongzheng District, Taiwan, 10002Regeneron study Site | Taoyuan City , Taiwan, 33305
Investigators
Study Director: Clinical Trial Management, Regeneron Pharmaceuticals
Study Documents (Full Text)
Documents provided by Regeneron PharmaceuticalsStudy Protocol  March 3, 2024Documents provided by Regeneron PharmaceuticalsStatistical Analysis Plan  July 31, 2024