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Monoclonal Antibodies

Tezepelumab for Severe Asthma in Children (HORIZON Trial)

Q: Is the upper age limit for this trial over 75 years?

This medical experiment is looking for participants aged 5 to 11 years old.

Q: Has the FDA given its approval to Tezepelumab?

Our team has evaluated Tezepelumab's safety to be a 3, as the drug is currently in Phase 3 clinical trials with evidence of both effectiveness and security.

Q: Is there an opportunity to participate in this research experiment?

This trial seeks to enrol 372 children with <a href="https://www.withpower.com/clinical-trials/asthma">asthma</a>, aged between 5 and 11 years.

Q: Are there any current opportunities to participate in this trial?

Affirmative. According to clinicaltrials.gov, this research has been in need of candidates since it was initially posted on August 24th 2023 and most recently revised on the 30th of the same month. In total, 38 sites are looking for 372 participants.

Q: How many individuals have volunteered to participate in the research?

Affirmative, clinicaltrials.gov indicates that this trial is currently enrolling patients. The study was first advertised on August 24th 2023 and was recently updated on the 30th of the same month. It seeks to recruit 372 participants from 38 different sites across the country.

Q: How many distinct sites are conducting this experiment?

Currently, this clinical trial has 38 sites where patients can sign up. These are located in Little Rock, Savannah and Schenectady amongst other cities, so it is advantageous to select the closest one to reduce any travelling expenses incurred if you decide to join.

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at baseline, week 4, week 24, and week 52

Awards & highlights

HORIZON 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.Check my eligibility

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.See study design

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.

HORIZON Trial 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.

HORIZON Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at baseline, week 4, week 24, and week 52

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized asthma exacerbation rate (AAER)

Secondary outcome measures

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

Asthma

Bronchitis bacterial

Myalgia

Bronchitis

Oral candidiasis

Headache

Fall

Hypertension

Cardiac failure

Cataract

Supraventricular tachycardia

Inguinal hernia

Intervertebral discitis

Pneumonia

Septic shock

Incisional hernia

Arthralgia

Invasive breast carcinoma

Acute kidney injury

Nephrolithiasis

Sinusitis

Cardiac arrest

100%

80%

60%

40%

20%

Study treatment Arm

Tezepelumab

Placebo

HORIZON 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

~2120

0 / 5Eligibility criteria met

Find a Location

Who is running the clinical trial?

AmgenIndustry Sponsor

1,371 Previous Clinical Trials

1,377,846 Total Patients Enrolled

23 Trials studying Asthma

6,165 Patients Enrolled for Asthma

AstraZenecaLead Sponsor

4,272 Previous Clinical Trials

288,612,303 Total Patients Enrolled

328 Trials studying Asthma

638,768 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.

Is the upper age limit for this trial over 75 years?

"This medical experiment is looking for participants aged 5 to 11 years old."

Answered by AI

Has the FDA given its approval to Tezepelumab?

"Our team has evaluated Tezepelumab's safety to be a 3, as the drug is currently in Phase 3 clinical trials with evidence of both effectiveness and security."

Answered by AI

Is there an opportunity to participate in this research experiment?

"This trial seeks to enrol 372 children with asthma, aged between 5 and 11 years."

Answered by AI

Are there any current opportunities to participate in this trial?

"Affirmative. According to clinicaltrials.gov, this research has been in need of candidates since it was initially posted on August 24th 2023 and most recently revised on the 30th of the same month. In total, 38 sites are looking for 372 participants."

Answered by AI

How many individuals have volunteered to participate in the research?

"Affirmative, clinicaltrials.gov indicates that this trial is currently enrolling patients. The study was first advertised on August 24th 2023 and was recently updated on the 30th of the same month. It seeks to recruit 372 participants from 38 different sites across the country."

Answered by AI

How many distinct sites are conducting this experiment?

"Currently, this clinical trial has 38 sites where patients can sign up. These are located in Little Rock, Savannah and Schenectady amongst other cities, so it is advantageous to select the closest one to reduce any travelling expenses incurred if you decide to join."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma

2023. "A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06023589.

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