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Monoclonal Antibodies

Dose 2 for Asthma (TATE Trial)

Phase 3
Waitlist Available
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients are eligible to be included in the study only if all of the following inclusion criteria and none of the
Be younger than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

TATE Trial Summary

This trial will study the effects of Benralizumab in children with severe asthma.

Eligible Conditions
  • Asthma

TATE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

TATE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~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
This trial's timeline: 3 weeks for screening, Varies for treatment, and 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 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Area Under the Serum Concentration-Time Curve From Time Zero to Day 28 (AUC0-28) of Benralizumab
Change From Baseline in Peripheral Blood Eosinophil Count up to Week 48
Clearance of Benralizumab
+4 more
Secondary outcome measures
Body Weight-Adjusted Clearance of Benralizumab
Change From Baseline in Interviewer-Administered Asthma Control Questionnaire (ACQ-IA) Score up to Week 48
Change From Baseline in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) up to Week 48
+2 more
Other outcome measures
Number of subjects with Adverse Events (AEs) and Serious Adverse Events (SAEs)

Side effects data

From 2016 Phase 3 trial • 220 Patients • NCT02075255
16%
Nasopharyngitis
11%
Bronchitis
8%
Headache
8%
Rhinitis
7%
Upper respiratory tract infection
5%
Sinusitis
4%
Hypertension
4%
Vertigo
3%
Back pain
3%
Pneumonia
1%
Asthma
1%
Cough
1%
Dyspnoea
1%
Cardiac failure acute
1%
Atrial fibrillation
1%
Presyncope
1%
Influenza
1%
Oesophagitis
1%
Gallbladder polyp
100%
80%
60%
40%
20%
0%
Study treatment Arm
Benra 30 mg q.8 Weeks
Benra 30 mg q.4 Weeks
Placebo

TATE Trial Design

2Treatment groups
Experimental Treatment
Group I: Dose 2Experimental Treatment1 Intervention
Greater than/equal to 35 kilos
Group II: Dose 1Experimental Treatment1 Intervention
Below 35 kilos
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Benralizumab
2016
Completed Phase 3
~10580

Find a Location

Who is running the clinical trial?

AstraZenecaLead Sponsor
4,271 Previous Clinical Trials
288,612,829 Total Patients Enrolled
328 Trials studying Asthma
639,103 Patients Enrolled for Asthma
Iqvia Pty LtdIndustry Sponsor
107 Previous Clinical Trials
170,038 Total Patients Enrolled
4 Trials studying Asthma
3,129 Patients Enrolled for Asthma
ParexelIndustry Sponsor
304 Previous Clinical Trials
101,158 Total Patients Enrolled
20 Trials studying Asthma
40,065 Patients Enrolled for Asthma

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma
2019. "PK/PD and Long Term Safety Study of Benralizumab in Children With Severe Eosinophilic Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04305405.
~6 spots leftby Apr 2025
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