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Monoclonal Antibodies

Tezepelumab for Severe Asthma in Children (HORIZON Trial)

Phase 3
Recruiting
Research Sponsored by AstraZeneca
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants must be 5 to < 12 years of age at the time of signing the assent form and their caregivers signing the ICF and at Visit 3
History of at least 2 severe asthma exacerbation events OR 1 severe asthma exacerbation event resulting in hospitalisation within 12 months prior to Visit 1
Must not have
History of cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis
History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation or mechanical ventilation
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at baseline, week 4, week 24, and week 52
Awards & highlights
Pivotal Trial

Summary

This trial will test if a drug can help kids with severe asthma better manage their condition.

Who is the study for?
This trial is for children aged 5 to less than 12 with severe asthma, who are already on medium to high-dose inhaled corticosteroids and another asthma controller. They must have had at least two serious flare-ups or one hospitalizing event in the past year, weigh over 16 kg, and show certain levels of lung function.
What is being tested?
The study tests Tezepelumab's effectiveness and safety against a placebo in managing severe asthma in kids. Participants will be randomly assigned to receive either Tezepelumab or a placebo alongside their standard asthma treatments.
What are the potential side effects?
While specific side effects for Tezepelumab aren't listed here, common ones may include reactions at the injection site, headache, fatigue, and potential worsening of asthma symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am between 5 and 11 years old.
Select...
I've had at least 2 severe asthma attacks or 1 that led to hospitalization in the last year.
Select...
My weight is at least 16 kg during my first and third visits.
Select...
My asthma diagnosis is confirmed by specific breathing tests.
Select...
My asthma is not under control.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have a history of cystic fibrosis, primary ciliary dyskinesia, or chronic sinusitis with nasal polyps.
Select...
I've had a severe asthma attack that led to a seizure or needed a breathing machine.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at baseline, week 4, week 24, and week 52
This trial's timeline: 3 weeks for screening, Varies for treatment, and at baseline, week 4, week 24, and week 52 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Annualized asthma exacerbation rate (AAER)
Secondary study objectives
AAER associated with ER visit or hospitalisation
AAER associated with allergic asthma
Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score
+17 more

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078
16%
Nasopharyngitis
12%
Upper respiratory tract infection
8%
Bronchitis bacterial
8%
Asthma
5%
Bronchitis
5%
Oral candidiasis
5%
Myalgia
4%
Headache
4%
Fall
3%
Hypertension
1%
Sinusitis
1%
Cardiac arrest
1%
Cardiac failure
1%
Supraventricular tachycardia
1%
Septic shock
1%
Incisional hernia
1%
Acute kidney injury
1%
Inguinal hernia
1%
Intervertebral discitis
1%
Pneumonia
1%
Arthralgia
1%
Invasive breast carcinoma
1%
Nephrolithiasis
1%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Tezepelumab
Placebo

Awards & Highlights

Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: TezepelumabExperimental Treatment1 Intervention
Participants will be receiving tezepelumab subcutaneous injection
Group II: PlaceboPlacebo Group1 Intervention
Participants will be receiving placebo through a subcutaneous injection
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tezepelumab
2018
Completed Phase 3
~2430

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor
1,462 Previous Clinical Trials
1,400,587 Total Patients Enrolled
25 Trials studying Asthma
6,301 Patients Enrolled for Asthma
AstraZenecaLead Sponsor
4,425 Previous Clinical Trials
289,140,572 Total Patients Enrolled
351 Trials studying Asthma
654,929 Patients Enrolled for Asthma
~242 spots leftby Apr 2027
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