Trial · NCT04612790
A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
NCT04612790, Phase 3, Terminated, AstraZeneca; results first posted 2024-11-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid. Trials, record NCT04612790. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04612790
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate the Use of Benralizumab in Patients With Bullous Pemphigoid.
- NCT number
- NCT04612790
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 67 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Bullous Pemphigoid
- Interventions
- Benralizumab, Placebo
- First posted
- 2020-11-03
- Last updated
- 2024-11-29
- Other registries' IDs
- eudract:2020-000287-32
- Results first posted
- 2024-11-29
- Limitations and caveats
- The study was terminated following a pre-planned futility analysis as the efficacy results did not pass the pre-defined futility hurdle with no new safety concerns.
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Responders at Week 36 | At Week 36 | A responder was defined as a participant who was in complete remission while off OCS for ≥2 months at Week 36. |
| Secondary | Percentage of Participants Who Remained Relapse-Free up to Week 36 | Up to Week 36 | Relapse was defined as the appearance of 3 or more new lesions per month (blisters, eczematous lesions, or urticarial plaques); or at least 1 large (\>10 centimeter \[cm\] diameter) eczematous lesion or urticarial plaques that did not heal within 1 week; or the extension of established lesions or daily pruritus in participants who had achieved disease control. |
| Secondary | Cumulative OCS Exposure From Baseline to Week 36 | Baseline (Day 1) and Week 36 | The cumulative OCS exposure was estimated as the sum over the relevant 4-week periods from the mixed-effect model for repeated measures (MMRM) model. Baseline was defined as the last recorded value on or prior to the date of randomization. Equivalents were prednisone equivalents (converted from mg). |
| Secondary | Change From Baseline in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score at Week 36 | Baseline (Day 1) and Week 36 | BPDAI is a clinician completed tool that is used for independent disease severity assessment to measure disease extent in BP. The total BPDAI activity score is calculated as the arithmetic sum of the 3 subcomponents - cutaneous blisters/erosions, cutaneous urticaria/erythema, and mucosal blisters/erosions. The BPDAI total activity gives an indication of disease activity, with score range from 0 (no disease activity) to 360 (severe disease activity). Higher scores indicating greater disease activity. Baseline was defined as the last recorded value on or prior to the date of randomization. |
| Secondary | Change From Baseline in BPDAI-Pruritus Score at Week 36 | Baseline (Day 1) and Week 36 | The BPDAI-Pruritus is a separate component of the BPDAI that asks the participant to grade the severity of pruritus over the past 24 hours, the past week, and the past month. For each recall period, severity of pruritus is rated on a numeric rating scale (NRS) ranging from 0 for no itch to 10 for maximal itching. The BPDAI-Pruritus score was computed as the sum of 3 components ranging from 0 to 30. Higher scores indicated worse condition. Baseline was defined as the last recorded value on or prior to the date of randomization. |
| Secondary | Cumulative OCS Exposure From Baseline to Week 16 | Baseline (Day 1) and Week 16 | The cumulative OCS exposure was estimated as the sum over the relevant 4-week periods from the MMRM model. Baseline was defined as the last recorded value on or prior to the date of randomization. Equivalents were prednisone equivalents (converted from mg). |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Responders at Week 36 | At Week 36 | FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 36 are included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Remained Relapse-Free up to Week 36 | Up to Week 36 | FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 36 are included in the analysis. | Percentage of participants | NUMBER |
| SECONDARY | Cumulative OCS Exposure From Baseline to Week 36 | Baseline (Day 1) and Week 36 | FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 36 are included in the analysis. | mg per kilogram (mg/kg) | MEAN |
| SECONDARY | Change From Baseline in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score at Week 36 | Baseline (Day 1) and Week 36 | FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only those participants with data collected at specified timepoints are reported. | Score on a scale | MEAN |
| SECONDARY | Change From Baseline in BPDAI-Pruritus Score at Week 36 | Baseline (Day 1) and Week 36 | FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only those participants with data collected at specified timepoints are reported. | Score on a scale | MEAN |
| SECONDARY | Cumulative OCS Exposure From Baseline to Week 16 | Baseline (Day 1) and Week 16 | FAS included all randomized participants who received at least 1 dose of IP, irrespective of their protocol adherence and continued participation in the study. Only participants who had the opportunity to reach Week 16 are included in the analysis. | mg/kg | MEAN |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Responders at Week 36 | DB Period: Benralizumab | 11.1 | 95% Confidence Interval -2.70 to 26.11 | Percentage of participants | |
| Percentage of Responders at Week 36 | DB Period: Placebo | 5.26 | 95% Confidence Interval -5.06 to 15.07 | Percentage of participants | |
| Percentage of Participants Who Remained Relapse-Free up to Week 36 | DB Period: Benralizumab | 23.78 | 95% Confidence Interval 5.95 to 41.61 | Percentage of participants | |
| Percentage of Participants Who Remained Relapse-Free up to Week 36 | DB Period: Placebo | 19.79 | 95% Confidence Interval 1.43 to 38.15 | Percentage of participants | |
| Cumulative OCS Exposure From Baseline to Week 36 | DB Period: Benralizumab | 71.37 | Standard Deviation 63.19 | mg per kilogram (mg/kg) | |
| Cumulative OCS Exposure From Baseline to Week 36 | DB Period: Placebo | 62.71 | Standard Deviation 46.90 | mg per kilogram (mg/kg) | |
| Change From Baseline in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score at Week 36 | DB Period: Benralizumab | -53.29 | Standard Deviation 46.33 | Score on a scale | |
| Change From Baseline in Bullous Pemphigoid Disease Area Index (BPDAI) Activity Score at Week 36 | DB Period: Placebo | -52.75 | Standard Deviation 17.36 | Score on a scale | |
| Change From Baseline in BPDAI-Pruritus Score at Week 36 | DB Period: Benralizumab | -5.57 | Standard Deviation 7.23 | Score on a scale | |
| Change From Baseline in BPDAI-Pruritus Score at Week 36 | DB Period: Placebo | -16.58 | Standard Deviation 9.21 | Score on a scale |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow28
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| DB Period (Up to 36 Weeks) | STARTED | DB Period: Benralizumab | 34 | |
| DB Period (Up to 36 Weeks) | STARTED | DB Period: Placebo | 33 | |
| DB Period (Up to 36 Weeks) | STARTED | OLE Period: Benralizumab (DB)/Benralizumab (OLE) | 0 | |
| DB Period (Up to 36 Weeks) | STARTED | OLE Period: Placebo (DB)/Benralizumab (OLE)- | 0 | |
| DB Period (Up to 36 Weeks) | COMPLETED | DB Period: Benralizumab | 16 | |
| DB Period (Up to 36 Weeks) | COMPLETED | DB Period: Placebo | 19 | |
| DB Period (Up to 36 Weeks) | COMPLETED | OLE Period: Benralizumab (DB)/Benralizumab (OLE) | 0 | |
| DB Period (Up to 36 Weeks) | COMPLETED | OLE Period: Placebo (DB)/Benralizumab (OLE)- | 0 | |
| DB Period (Up to 36 Weeks) | NOT COMPLETED | DB Period: Benralizumab | 18 | |
| DB Period (Up to 36 Weeks) | NOT COMPLETED | DB Period: Placebo | 14 |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 participant flowAdverse events324
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Gastrointestinal disorder | Gastrointestinal disorders | DB Period: Benralizumab | 0 | 34 | 0 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | DB Period: Placebo | 0 | 33 | 0 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | OLE Period: Benralizumab (DB)/Benralizumab (OLE) | 0 | 16 | 0 |
| other | Gastrointestinal disorder | Gastrointestinal disorders | OLE Period: Placebo (DB)/Benralizumab (OLE) | 1 | 18 | 1 |
| other | Haemorrhoids | Gastrointestinal disorders | DB Period: Benralizumab | 0 | 34 | 0 |
| other | Haemorrhoids | Gastrointestinal disorders | DB Period: Placebo | 0 | 33 | 0 |
| other | Haemorrhoids | Gastrointestinal disorders | OLE Period: Benralizumab (DB)/Benralizumab (OLE) | 0 | 16 | 0 |
| other | Haemorrhoids | Gastrointestinal disorders | OLE Period: Placebo (DB)/Benralizumab (OLE) | 1 | 18 | 1 |
| other | Hiatus hernia | Gastrointestinal disorders | DB Period: Benralizumab | 0 | 34 | 0 |
| other | Hiatus hernia | Gastrointestinal disorders | DB Period: Placebo | 0 | 33 | 0 |
1 to 10 of 324Source ClinicalTrials.gov
See all 324 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | DB Period: Benralizumab | 1 | 34 |
| Total, all-cause mortality | DB Period: Placebo | 1 | 33 |
| Total, all-cause mortality | OLE Period: Benralizumab (DB)/Benralizumab (OLE) | 0 | 16 |
| Total, all-cause mortality | OLE Period: Placebo (DB)/Benralizumab (OLE) | 0 | 18 |
| Total, other adverse events | DB Period: Benralizumab | 22 | 34 |
| Total, other adverse events | DB Period: Placebo | 23 | 33 |
| Total, other adverse events | OLE Period: Benralizumab (DB)/Benralizumab (OLE) | 8 | 16 |
| Total, other adverse events | OLE Period: Placebo (DB)/Benralizumab (OLE) | 8 | 18 |
| Total, serious adverse events | DB Period: Benralizumab | 9 | 34 |
| Total, serious adverse events | DB Period: Placebo | 8 | 33 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT04612790
GET https://conductscience.org/api/trials/v1/NCT04612790/flow?page=2