Trial · NCT04605094
Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis
NCT04605094, Phase 2, Terminated, AstraZeneca; results first posted 2023-06-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis. Trials, record NCT04605094. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04605094
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Study of the Use of Benralizumab for Patients With Moderate to Severe Atopic Dermatitis
- NCT number
- NCT04605094
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 194 participants, actual
- Lead sponsor
- AstraZeneca
- Conditions
- Atopic Dermatitis
- Interventions
- Benralizumab, Placebo / Benralizumab
- First posted
- 2020-10-27
- Last updated
- 2023-08-31
- Results first posted
- 2023-06-27
- Limitations and caveats
- The study was terminated as the study did not support the continued development of benralizumab for the indication of AD.
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of ≥2 Points at Week 16 Relative to Baseline | Baseline (Week 0) and at Week 16 | The IGA is an instrument used in clinical studies to rate the severity of AD globally, based on a 5-point scale ranging from 0 = clear; 1 = almost clear; 2 = mild disease; 3 = moderate disease; 4 = severe disease. The IGA used clinical characteristics of erythema, infiltration, papulation, oozing, and crusting as guidelines for the overall severity assessment. A higher score indicated greater severity. A responder at Week 16 was defined as having IGA 0/1 and a decrease in IGA of ≥2 points at Week 16 relative to baseline. Participants who withdrew from the study/required rescue therapy after Day 28 were considered as non-responders from the time these events occurred. Baseline was defined as the last recorded value on or prior to the date of randomization. |
| Secondary | Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 | Baseline (Week 0) and at Week 16 | The EASI assessed the severity and extent of AD. Severity of 4 AD disease characteristics (erythema, induration/papulation, excoriation \[scratching\], lichenification) each were assessed on a scale of 0 (absent) to 3 (severe) in each of 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Total body total score=sum of the region total scores; ranged from 0 to 72. Participants were classified as responders if they achieved at least 75% reduction from baseline in their EASI total score at Week 16. Participants who withdrew from study/required rescue therapy after Day 28 were non-responders from the time these events occurred. Higher scores indicated a more severe or more extensive condition. Baseline was defined as the last recorded value on or prior to the date of randomization. |
| Secondary | Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 | Baseline (Week 0) and at Week 16 | The EASI assessed the severity and extent of AD. Severity of 4 AD disease characteristics (erythema, induration/papulation, excoriation \[scratching\], lichenification) each were assessed on a scale of 0 (absent) to 3 (severe) in each of 4 body regions (head/neck, trunk, upper limbs, and lower limbs). Total body total score=sum of the region total scores; ranged from 0 to 72. Participants were classified as responders if they achieved at least 90% reduction from baseline in their EASI total score at Week 16. Participants who withdrew from study/required rescue therapy after Day 28 were non-responders from the time these events occurred. Higher scores indicated a more severe or more extensive condition. Baseline was defined as the last recorded value on or prior to the date of randomization. |
| Secondary | Percentage of Participants With an Improvement of ≥4 or More Points in Peak Pruritus Weekly Score | At Week 16 | The peak pruritus numeric rating scale (NRS) was a 1-item daily assessment of the worst itch the participant experienced over the past 24 hours. The score ranged from 0 to 10, with 0 being "no itch" and 10 being "worst itch imaginable" and so a reduction in score was considered an improvement. A responder was defined as having an improvement of 4 or more points relative to baseline. Participants who withdrew from the study/required rescue therapy after Day 28 were considered as non-responders from the time these events occurred. The Week 16 weekly scores were defined as the average of the daily scores for the 7 days prior to the weekly score. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of ≥2 Points at Week 16 Relative to Baseline | Baseline (Week 0) and at Week 16 | The FAS consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 | Baseline (Week 0) and at Week 16 | The FAS consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 | Baseline (Week 0) and at Week 16 | The FAS consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With an Improvement of ≥4 or More Points in Peak Pruritus Weekly Score | At Week 16 | The FAS consisted of all randomized participants who received at least 1 dose of study drug, irrespective of their protocol adherence and continued participation in the study. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group8
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of ≥2 Points at Week 16 Relative to Baseline | Benralizumab | 9.4 | 95% Confidence Interval 3.36 to 14.93 | percentage of participants | |
| Percentage of Participants With an Investigator Global Assessment (IGA) 0/1 and a Decrease in IGA of ≥2 Points at Week 16 Relative to Baseline | Placebo | 17.3 | 95% Confidence Interval 10.40 to 25.12 | percentage of participants | |
| Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 | Benralizumab | 19.8 | 95% Confidence Interval 11.71 to 27.45 | percentage of participants | |
| Percentage of Participants Who Experienced 75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) at Week 16 | Placebo | 24.5 | 95% Confidence Interval 16.27 to 33.19 | percentage of participants | |
| Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 | Benralizumab | 7.3 | 95% Confidence Interval 2.05 to 12.42 | percentage of participants | |
| Percentage of Participants Who Experienced 90% Reduction From Baseline in Eczema Area and Severity Index (EASI-90) at Week 16 | Placebo | 15.3 | 95% Confidence Interval 8.33 to 22.50 | percentage of participants | |
| Percentage of Participants With an Improvement of ≥4 or More Points in Peak Pruritus Weekly Score | Benralizumab | 14.6 | 95% Confidence Interval 7.87 to 21.70 | percentage of participants | |
| Percentage of Participants With an Improvement of ≥4 or More Points in Peak Pruritus Weekly Score | Placebo | 14.3 | 95% Confidence Interval 7.28 to 20.90 | percentage of participants |
Source ClinicalTrials.gov
Participant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Benralizumab | 96 | |
| Overall Study | STARTED | Placebo | 98 | |
| Overall Study | COMPLETED | Benralizumab | 37 | |
| Overall Study | COMPLETED | Placebo | 37 | |
| Overall Study | NOT COMPLETED | Benralizumab | 59 | |
| Overall Study | NOT COMPLETED | Placebo | 61 |
Source ClinicalTrials.gov
Adverse events33
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 | Bronchitis | Infections and infestations | Benralizumab | 5 | 96 | 5 |
| other | Bronchitis | Infections and infestations | Placebo | 0 | 98 | 0 |
| other | Bronchitis | Infections and infestations | Placebo to Benralizumab | 4 | 87 | 4 |
| other | Conjunctivitis | Infections and infestations | Benralizumab | 3 | 96 | 4 |
| other | Conjunctivitis | Infections and infestations | Placebo | 0 | 98 | 0 |
| other | Conjunctivitis | Infections and infestations | Placebo to Benralizumab | 6 | 87 | 6 |
| other | COVID-19 | Infections and infestations | Benralizumab | 21 | 96 | 23 |
| other | COVID-19 | Infections and infestations | Placebo | 4 | 98 | 4 |
| other | COVID-19 | Infections and infestations | Placebo to Benralizumab | 14 | 87 | 14 |
| other | Nasopharyngitis | Infections and infestations | Benralizumab | 9 | 96 | 10 |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Benralizumab | 0 | 96 |
| Total, all-cause mortality | Placebo | 0 | 98 |
| Total, all-cause mortality | Placebo to Benralizumab | 0 | 87 |
| Total, other adverse events | Benralizumab | 38 | 96 |
| Total, other adverse events | Placebo | 10 | 98 |
| Total, other adverse events | Placebo to Benralizumab | 29 | 87 |
| Total, serious adverse events | Benralizumab | 3 | 96 |
| Total, serious adverse events | Placebo | 0 | 98 |
| Total, serious adverse events | Placebo to Benralizumab | 2 | 87 |
Source ClinicalTrials.gov
Papers0
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/NCT04605094
GET https://conductscience.org/api/trials/v1/NCT04605094/events?page=2