Adults 6 to 14, any sex, with Severe Uncontrolled Asthma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Clearance of BenralizumabPrimary· Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit
Blood samples were collected to determine the clearance of benralizumab. This was an empirical Bayesian estimate (EBE) derived posthoc using population PK analysis.
Group
Value
95% CI
All Participants
0.156
± 0.0598
Area Under the Serum Concentration-Time Curve From Time Zero to Day 28 (AUC0-28) of BenralizumabPrimary· Pre-dose on Days 0, 28 and post-dose on Days 1, 7, 14
Blood samples were collected to determine the AUC0-28 of benralizumab and it was calculated by linear up/log down trapezoidal summation. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
36918.01
± 24.61
Benralizumab Dose 2, Aged 6-11 Years
75593.37
± 39.96
Benralizumab Dose 1, Aged 6-14 Years
36918.01
± 24.61
Benralizumab Dose 2, Aged 6-14 Years
73670.51
± 38.86
Maximum Observed Serum Concentration (Cmax) of BenralizumabPrimary· Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit
Blood samples were collected to determine Cmax of benralizumab and it was directly calculated from the individual concentration-time curve. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
1901.18
± 28.42
Benralizumab Dose 2, Aged 6-11 Years
3118.69
± 47.35
Benralizumab Dose 1, Aged 6-14 Years
1901.18
± 28.42
Benralizumab Dose 2, Aged 6-14 Years
3090.85
± 43.66
Terminal Phase Elimination Half-Life (t1/2) of BenralizumabPrimary· Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit
Blood samples were collected to determine the t1/2 of benralizumab and it was calculated as natural logarithm of 2 \[ln(2)\]/terminal rate constant (λZ). This was an EBE derived posthoc using population PK analysis.
Group
Value
95% CI
All Participants
14.4
6.94 – 23.4
Time to Achieve Maximum Observed Serum Concentration (Tmax) of BenralizumabPrimary· Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit
Blood samples were collected to determine the tmax of benralizumab and it was directly calculated from the individual concentration-time curve. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
6.91
0.93 – 14.95
Benralizumab Dose 2, Aged 6-11 Years
7.26
1.10 – 14.01
Benralizumab Dose 1, Aged 6-14 Years
6.91
0.93 – 14.95
Benralizumab Dose 2, Aged 6-14 Years
7.94
1.10 – 14.01
Trough Concentration of Benralizumab at Week 16 (Ctrough16)Primary· Pre-dose on Day 112
Blood samples were collected to determine the trough concentration at Week 16, the lowest concentration reached by benralizumab before the next dose was administered. The PK parameters were estimated using non-compartmental analysis method.
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
142.42
± 256.34
Benralizumab Dose 2, Aged 6-11 Years
339.35
± 409.24
Benralizumab Dose 1, Aged 6-14 Years
142.42
± 256.34
Benralizumab Dose 2, Aged 6-14 Years
340.46
± 363.69
Change From Baseline in Peripheral Blood Eosinophil Count up to Week 48Primary· Baseline (Day 0) and at Weeks 4, 8, 12, 16, 24 and 48
Blood samples were collected for determination of eosinophil count levels and were assessed in a central laboratory. Baseline is the last non-missing measurement prior to the first dose of study treatment.
Week 4
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-447.3
± 283.76
Benralizumab Dose 2, Aged 6-11 Years
-436.9
± 408.28
Benralizumab Dose 1, Aged 6-14 Years
-447.3
± 283.76
Benralizumab Dose 2, Aged 6-14 Years
-455.3
± 385.58
Week 8
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-445.3
± 276.20
Benralizumab Dose 2, Aged 6-11 Years
-453.8
± 396.03
Benralizumab Dose 1, Aged 6-14 Years
-445.3
± 276.20
Benralizumab Dose 2, Aged 6-14 Years
-470.7
± 374.25
Week 12
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-443.3
± 286.85
Benralizumab Dose 2, Aged 6-11 Years
-455.8
± 419.32
Benralizumab Dose 1, Aged 6-14 Years
-443.3
± 286.85
Benralizumab Dose 2, Aged 6-14 Years
-472.9
± 393.49
Week 16
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-446.7
± 279.12
Benralizumab Dose 2, Aged 6-11 Years
-402.7
± 384.61
Benralizumab Dose 1, Aged 6-14 Years
-446.7
± 279.12
Benralizumab Dose 2, Aged 6-14 Years
-430.0
± 378.68
Week 24
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-354.2
± 323.99
Benralizumab Dose 2, Aged 6-11 Years
-436.9
± 405.90
Benralizumab Dose 1, Aged 6-14 Years
-354.2
± 323.99
Benralizumab Dose 2, Aged 6-14 Years
-457.9
± 397.77
Week 48
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-434.0
± 286.15
Benralizumab Dose 2, Aged 6-11 Years
-453.8
± 392.78
Benralizumab Dose 1, Aged 6-14 Years
-434.0
± 286.15
Benralizumab Dose 2, Aged 6-14 Years
-474.3
± 385.04
Body Weight-Adjusted Clearance of BenralizumabSecondary· Pre-dose on Days 0, 28, 56, 112, 168 and post-dose on Days 1, 7, 14, 84, 336; and at early discontinuation or withdrawal visit
Blood samples were collected to determine the clearance of benralizumab. This was an EBE derived posthoc using population PK analysis.
Group
Value
95% CI
All Participants
0.00408
± 0.000764
Number of Participants With Anti-Drug Antibodies (ADA) Response to BenralizumabSecondary· Pre-dose at Baseline (Day 0), Weeks 8, 16 and 24 and post-dose at Week 48; and at early discontinuation or withdrawal visit
Blood samples were analyzed for the presence of ADAs for benralizumab. ADA prevalence: ADA positive (+ve) at any time point including baseline and/or post baseline. Treatment induced ADA+ve: ADA negative (-ve) at baseline and post-baseline ADA+ve. Treatment-boosted ADA+ve: baseline +ve ADA titer that was boosted by \>4-fold or higher-level following study drug administration. Treatment-emergent ADA+ve: either treatment-induced ADA+ve or treatment-boosted ADA+ve. Persistently +ve ADA: having at least 2 post-baseline ADA+ve assessments with at least 16 weeks (112 days) between the first and last
ADA prevalence
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
3
Benralizumab Dose 2, Aged 6-11 Years
1
Benralizumab Dose 1, Aged 6-14 Years
3
Benralizumab Dose 2, Aged 6-14 Years
1
Treatment-emergent ADA+ve
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
3
Benralizumab Dose 2, Aged 6-11 Years
1
Benralizumab Dose 1, Aged 6-14 Years
3
Benralizumab Dose 2, Aged 6-14 Years
1
Post-baseline ADA+ve
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
3
Benralizumab Dose 2, Aged 6-11 Years
1
Benralizumab Dose 1, Aged 6-14 Years
3
Benralizumab Dose 2, Aged 6-14 Years
1
Baseline and at least 1 post-baseline ADA+ve
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
0
Benralizumab Dose 2, Aged 6-11 Years
0
Benralizumab Dose 1, Aged 6-14 Years
0
Benralizumab Dose 2, Aged 6-14 Years
0
Only baseline ADA+ve
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
0
Benralizumab Dose 2, Aged 6-11 Years
0
Benralizumab Dose 1, Aged 6-14 Years
0
Benralizumab Dose 2, Aged 6-14 Years
0
Persistently ADA+ve
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
1
Benralizumab Dose 2, Aged 6-11 Years
0
Benralizumab Dose 1, Aged 6-14 Years
1
Benralizumab Dose 2, Aged 6-14 Years
0
Transiently ADA+ve
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
2
Benralizumab Dose 2, Aged 6-11 Years
1
Benralizumab Dose 1, Aged 6-14 Years
2
Benralizumab Dose 2, Aged 6-14 Years
1
nAb prevalence
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
3
Benralizumab Dose 2, Aged 6-11 Years
1
Benralizumab Dose 1, Aged 6-14 Years
3
Benralizumab Dose 2, Aged 6-14 Years
1
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) up to Week 48Secondary· Baseline (Day 0) and at Weeks 16 and 48
The FEV1 was defined as the volume of air exhaled from the lungs in the first second of a forced expiration and was measured by spirometry. Baseline is the last non-missing measurement with acceptable quality prior to the first dose of study treatment.
Week 16
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-0.001
± 0.2434
Benralizumab Dose 2, Aged 6-11 Years
-0.119
± 0.2435
Benralizumab Dose 1, Aged 6-14 Years
-0.001
± 0.2434
Benralizumab Dose 2, Aged 6-14 Years
-0.165
± 0.2609
Week 48
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
0.003
± 0.3412
Benralizumab Dose 2, Aged 6-11 Years
0.425
± 0.4395
Benralizumab Dose 1, Aged 6-14 Years
0.003
± 0.3412
Benralizumab Dose 2, Aged 6-14 Years
0.428
± 0.4209
Change From Baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) Score up to Week 48Secondary· Baseline (Day 0), at Weeks 16 and 48; and at early discontinuation or withdrawal visit
The ACQ-IA is a 6-item assessment comprised of 6 patient-reported items. Participants were asked to record their experience with 5 symptoms (night-time waking, symptoms on waking, activity limitation, shortness of breath, and wheezing) and use of short-acting beta-2 agonist (SABA) over the previous week using a 7-point scale (0 = no impairment; and 6 = maximum impairment). The ACQ-IA score was calculated by the mean of the 7 equally weighted items. The score ranged from 0 (well controlled) to 6 (extremely poorly controlled). Higher scores indicated poor asthma control. Baseline is the last non
Week 16
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-0.62
± 0.890
Benralizumab Dose 2, Aged 6-11 Years
-1.18
± 1.717
Benralizumab Dose 1, Aged 6-14 Years
-0.62
± 0.890
Benralizumab Dose 2, Aged 6-14 Years
-1.06
± 1.696
Week 48
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
-0.56
± 1.252
Benralizumab Dose 2, Aged 6-11 Years
-1.36
± 1.369
Benralizumab Dose 1, Aged 6-14 Years
-0.56
± 1.252
Benralizumab Dose 2, Aged 6-14 Years
-1.31
± 1.324
Number of Responders in Interviewer-Administered Patient Global Impression of Change (PGIC)-IA and Clinician Global Impression of Change (CGIC) QuestionnairesSecondary· At Weeks 16 and 48; and at early discontinuation or withdrawal visit
The PGIC-IA and CGIC instruments were used for an overall evaluation of response to treatment, conducted separately by the Investigator and by the participant (administered by trained individuals to help the child understand the question and response options), using a 7-point scale: 1=very much improved; 2=much improved; 3=minimally improved; 4=no change; 5=minimally worse; 6=much worse; and 7=very much worse. The Investigator (clinician) and the participant were asked to rate the degree of change in the overall asthma status compared to the start of study treatment visit. Participants were de
PGIC-IA, Week 16, improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
13
Benralizumab Dose 2, Aged 6-11 Years
12
Benralizumab Dose 1, Aged 6-14 Years
13
Benralizumab Dose 2, Aged 6-14 Years
13
PGIC-IA, Week 16, much improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
10
Benralizumab Dose 2, Aged 6-11 Years
10
Benralizumab Dose 1, Aged 6-14 Years
10
Benralizumab Dose 2, Aged 6-14 Years
11
PGIC-IA, Week 16, very much improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
4
Benralizumab Dose 2, Aged 6-11 Years
8
Benralizumab Dose 1, Aged 6-14 Years
4
Benralizumab Dose 2, Aged 6-14 Years
9
PGIC-IA, Week 48, improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
13
Benralizumab Dose 2, Aged 6-11 Years
12
Benralizumab Dose 1, Aged 6-14 Years
13
Benralizumab Dose 2, Aged 6-14 Years
13
PGIC-IA, Week 48, much improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
9
Benralizumab Dose 2, Aged 6-11 Years
10
Benralizumab Dose 1, Aged 6-14 Years
9
Benralizumab Dose 2, Aged 6-14 Years
11
PGIC-IA, Week 48, very much improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
9
Benralizumab Dose 2, Aged 6-11 Years
9
Benralizumab Dose 1, Aged 6-14 Years
9
Benralizumab Dose 2, Aged 6-14 Years
10
CGIC, Week 16, improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
13
Benralizumab Dose 2, Aged 6-11 Years
11
Benralizumab Dose 1, Aged 6-14 Years
13
Benralizumab Dose 2, Aged 6-14 Years
12
CGIC, Week 16, much improved
Group
Value
95% CI
Benralizumab Dose 1, Aged 6-11 Years
8
Benralizumab Dose 2, Aged 6-11 Years
9
Benralizumab Dose 1, Aged 6-14 Years
8
Benralizumab Dose 2, Aged 6-14 Years
9
Adverse events — posted to ClinicalTrials.gov
Time frame: Treatment-emergent adverse events were collected from the start of study drug administration (Day 1) until end of follow-up, approximately up to Week 53.
Reporting threshold: 5%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
This study will evaluate the PK, PD and long-term safety of Benralizumab administered subcutaneously in 30 children aged 6 to 11 years with severe eosinophilic asthma. Up to an additional 3 Japanese patients aged 12 to 14 years will be enrolled to meet local regulatory requirements.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07444567 — Roll-over Study for Participants Who Have Completed a Previous Clinical Study With Benralizumab (Fasenra) and Benefit Fr
· Phase 3
· not yet recruiting
NCT06512883 — A Trial to Investigate Benralizumab in Children With Eosinophilic Diseases
· Phase 3
· recruiting
NCT06465485 — STEP: Phase IIIb Study of Benralizumab to Step-down Maintenance Therapy in Patients With Severe Eosinophilic Asthma
· Phase 3
· active not recruiting
NCT06385236 — Leveraging Pharmacogenomics in Asthma for Predication, Mechanism and Endotyping
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· recruiting
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· terminated
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by AstraZeneca
Last refreshed: 18 May 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04305405.