Trial · NCT04157348
Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
NCT04157348, Phase 3, Active not recruiting, AstraZeneca; results first posted 2025-01-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab. Trials, record NCT04157348. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04157348
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Benralizumab in EGPA Compared to Mepolizumab.
- NCT number
- NCT04157348
- Status
- Active not recruiting
- Phases
- Phase 3
- Enrollment
- 140 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Eosinophilic Granulomatous Vasculitis
- Interventions
- Benralizumab, Mepolizumab, Placebo to Mepolizumab, Placebo to Benralizumab
- First posted
- 2019-11-08
- Last updated
- 2026-11-09
- Other registries' IDs
- eudract:2019-001832-77
- Results first posted
- 2025-01-14
Source ClinicalTrials.gov
Registered outcomes32
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Percentage of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 4 mg/day (main remission definition) at both Weeks 36 and 48. |
| Primary | Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Supportive endpoint: Proportion of patients with relapsing or refractory EGPA, achieving remission, defined as BVAS = 0 and OCS dose ≤ 7.5 mg/day (supportive remission definition) at both Weeks 36 and 48. |
| Secondary | Total Accrued Duration of Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks. | Total accrued duration of remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week. |
| Secondary | Total Accrued Duration of Sustained Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks | Total accrued duration of sustained remission for the following categories: 0 week, \> 0 to \< 12 week, 12 to \< 24 week, 24 to \< 36 week, ≥ 36 week. |
| Secondary | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | from baseline to end of DB period, 52 Weeks | Time from randomization to first Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse, where relapse is defined as any of the following: * Active vasculitis (BVAS \> 0); OR * Active asthma symptoms and/or signs with a corresponding worsening in ACQ-6 score; OR * Active nasal and/or sinus disease, with a corresponding worsening in at least one of the sino-nasal symptom questions; warranting any of the following: * An increased dose of OCS therapy to \> 4 mg/day prednisolone total daily dose; OR * An increased dose or addition of immunosuppressive therapy; OR * Hospitalization related to EGPA worsening Calculated using the Kaplan-Meier technique. |
| Secondary | Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | from baseline to end of DB period, 52 Weeks | Annualized Eosinophilic Granulomatosis with Polyangiitis (EGPA) relapse rate through end of DB treatment period. The estimate of annualized relapse rate (relapses per year) and the corresponding 95% CIs were calculated using a negative binomial model. The response variable in the model is the number of relapses experienced by a subject up to Week 52. The logarithm of the subject's corresponding follow-up time up to Week 52 was used as an offset variable to adjust for subjects having different follow-up times during which the events occur. The covariates in the model include treatment arm, baseline dose of prednisone, baseline BVAS and region. |
| Secondary | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | last 4 weeks of DB period | Average daily dose of prednisolone/prednisone and change from baseline during Week 48 through 52, or last 28 days prior to last double-blind assessment for those that withdrew |
| Secondary | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Proportion of patients with average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: 0 mg; \>0 to ≤ 4 mg; \> 4 to ≤ 7.5 mg and \> 7.5 mg |
| Secondary | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Percentage reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: no reduction or withdrawal from treatment; \< 25% reduction; 25 to \< 50% reduction; 50 to \<75% reduction; 75 to \< 100% reduction; 100% reduction. |
| Secondary | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Proportion of subjects with reduction from baseline in average daily dose of prednisolone/prednisone during Week 48 through 52 in each category: \>= 50% reduction; 100% reduction; OCS dose \<= 4 mg/day. |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 registered outcomesOutcomes32
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Week 36 and Week 48 | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Accrued Duration of Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks. | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Total Accrued Duration of Sustained Remission During DB Treatment Period | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time From Randomization to First Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | percentage of subjects | NUMBER |
| SECONDARY | Annualized Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse Rate | from baseline to end of DB period, 52 Weeks | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | relapses per year | LEAST_SQUARES_MEAN |
| SECONDARY | Average Daily Dose of Prednisolone/Prednisone and Change From Baseline During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | mg | MEAN |
| SECONDARY | Proportion of Patients With Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Proportion of Subjects With Reduction From Baseline in Average Daily Dose of Prednisolone/Prednisone During Week 48 Through 52 | last 4 weeks of DB period | Full Analysis Set: All patients randomized and receiving at least one (1) dose of IP are included in the full analysis set, irrespective of their protocol adherence and continued participation in the study. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 outcomesResults by group1,250
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Benralizumab 30 mg | 40 | Participants | ||
| Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Mepolizumab 300 mg | 40 | Participants | ||
| Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Benralizumab 30 mg | 55 | Participants | ||
| Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Mepolizumab 300 mg | 52 | Participants | ||
| Total Accrued Duration of Remission During DB Treatment Period | Benralizumab 30 mg | main remission / 0 week | 9 | Participants | |
| Total Accrued Duration of Remission During DB Treatment Period | Mepolizumab 300 mg | main remission / 0 week | 15 | Participants | |
| Total Accrued Duration of Remission During DB Treatment Period | Benralizumab 30 mg | main remission / >0 to <12 weeks | 13 | Participants | |
| Total Accrued Duration of Remission During DB Treatment Period | Mepolizumab 300 mg | main remission / >0 to <12 weeks | 10 | Participants | |
| Total Accrued Duration of Remission During DB Treatment Period | Benralizumab 30 mg | main remission / 12 to <24 weeks | 8 | Participants | |
| Total Accrued Duration of Remission During DB Treatment Period | Mepolizumab 300 mg | main remission / 12 to <24 weeks | 8 | Participants |
1 to 10 of 1,250Source ClinicalTrials.gov
See all 1,250 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Double-blind Treatment Period | STARTED | Benralizumab 30 mg | 70 | |
| Double-blind Treatment Period | STARTED | Mepolizumab 300 mg | 70 | |
| Double-blind Treatment Period | COMPLETED | Benralizumab 30 mg | 69 | |
| Double-blind Treatment Period | COMPLETED | Mepolizumab 300 mg | 67 | |
| Double-blind Treatment Period | NOT COMPLETED | Benralizumab 30 mg | 1 | |
| Double-blind Treatment Period | NOT COMPLETED | Mepolizumab 300 mg | 3 | |
| Open-label Extension Period | STARTED | Benralizumab 30 mg | 66 | |
| Open-label Extension Period | STARTED | Mepolizumab 300 mg | 62 | |
| Open-label Extension Period | COMPLETED | Benralizumab 30 mg | 0 | |
| Open-label Extension Period | COMPLETED | Mepolizumab 300 mg | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events264
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 | Conjunctivitis | Infections and infestations | Benra 30 mg - DB | 2 | 70 | 2 |
| other | Conjunctivitis | Infections and infestations | Mepo 300 mg - DB | 1 | 70 | 1 |
| other | Conjunctivitis | Infections and infestations | Benra 30 mg - OLE | 1 | 66 | 1 |
| other | Conjunctivitis | Infections and infestations | Mepo 300 mg Switched to Benra 30 mg - OLE | 4 | 62 | 4 |
| other | Bronchitis | Infections and infestations | Benra 30 mg - DB | 4 | 70 | 4 |
| other | Bronchitis | Infections and infestations | Mepo 300 mg - DB | 5 | 70 | 8 |
| other | Bronchitis | Infections and infestations | Benra 30 mg - OLE | 7 | 66 | 9 |
| other | Bronchitis | Infections and infestations | Mepo 300 mg Switched to Benra 30 mg - OLE | 2 | 62 | 3 |
| other | COVID-19 | Infections and infestations | Benra 30 mg - DB | 14 | 70 | 14 |
| other | COVID-19 | Infections and infestations | Mepo 300 mg - DB | 18 | 70 | 18 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benra 30 mg - DB | 0 | 70 |
| Total, all-cause mortality | Mepo 300 mg - DB | 0 | 70 |
| Total, all-cause mortality | Benra 30 mg - OLE | 0 | 66 |
| Total, all-cause mortality | Mepo 300 mg Switched to Benra 30 mg - OLE | 1 | 62 |
| Total, other adverse events | Benra 30 mg - DB | 46 | 70 |
| Total, other adverse events | Mepo 300 mg - DB | 56 | 70 |
| Total, other adverse events | Benra 30 mg - OLE | 43 | 66 |
| Total, other adverse events | Mepo 300 mg Switched to Benra 30 mg - OLE | 46 | 62 |
| Total, serious adverse events | Benra 30 mg - DB | 4 | 70 |
| Total, serious adverse events | Mepo 300 mg - DB | 9 | 70 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers3
The papers the trial lists on ClinicalTrials.gov.
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 comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Benralizumab 30 mg vs Mepolizumab 300 mg: Supportive Endpoint: Proportion of Subjects Who Achieved Supportive Remission at Both Weeks 36 and 48 | Trial comparisons |
| Benralizumab 30 mg vs Mepolizumab 300 mg: Number of Subjects Who Achieved Main Remission at Both Weeks 36 and 48 | Trial comparisons |
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/NCT04157348
GET https://conductscience.org/api/trials/v1/NCT04157348/registered?page=2