A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe Asthma
Recruiting · 40 sites across 15 states
Always free
Study care at no cost to you
For your time and travel
Many studies pay you back
Most need no insurance or papers
Legal status usually isn't required; we'll tell you each study's requirements
Interpreters available
Ask for your language
Your choice
Voluntary — you can stop anytime
What is this study?
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
It is , overseen by an independent and licensed medical staff.
Read the full clinical description
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
Who this study is looking for
In plain language, from the study's own rules. The study team confirms the full details with you — this isn't a final yes or no.
✅ You may be able to join if…
- •Children ages 5 to under 12 years old (at the time of signing the assent form and when caregivers sign the study forms).
- •A doctor has diagnosed severe asthma, confirmed and evaluated for at least 6 months before Visit 1.
- •They have been on a medium or high dose of inhaled corticosteroids (ICS) for at least 3 months, with a stable dose for at least 1 month before Visit 1.
- •They take at least one other daily asthma controller medicine (such as a long-acting beta agonist, leukotriene receptor antagonist, or long-acting muscarinic antagonist) for at least 3 months with a stable dose for at least 1 month before Visit 1.
- •They have asthma evidence and signs of uncontrolled asthma (for example: lung test results after an albuterol/breathing test, or other asthma test results, plus symptoms or reliever use).
🚫 You may not be able to join if…
- •They have had vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
- •They have another clinically significant disease or disorder (besides asthma) that could put them at risk or affect study results or their ability to join.
- •They had a significant worsening of asthma or an asthma flare that needed systemic (by mouth or injection) corticosteroids, or an increase in oral corticosteroids dose within 30 days before Visit 1.
- •They changed their inhaled corticosteroid (ICS) dose within 1 month before Visit 1.
- •They had a life-threatening asthma flare that caused a hypoxic seizure or needed intubation.
Are you a good fit?
Simplified highlights. The study team always confirms the full details with you.
- ✓Adults roughly 5–11
- ✓Have COPD (chronic lung disease) or Asthma
What to expect, step by step
- 1
Usually a few weeks
The study team checks whether the study is a good fit for you, with a visit and sometimes lab tests. You can ask any questions before deciding.
- 2
Treatment
If you join and choose to continue, you receive the study treatment and are watched closely by medical staff.
- 3
Follow-up
After treatment, the team checks on your health and confirms the visit schedule with you. You can leave the study at any point.
Has this treatment been tested before?
Yes. This treatment has already been through earlier human studies for safety before reaching this stage.
What you need to know before you apply
What is this study testing?+
To assess the efficacy and safety of tezepelumab in pediatric participants with severe uncontrolled asthma on medium to high-dose inhaled corticosteroids (ICS) and at least one additional asthma controller medication with or without oral corticosteroids.
Is it safe? Who makes sure of that?+
This is a late-stage study (Phase 3), testing how well the treatment works in more people. Every study is reviewed and monitored by an independent ethics board (called an IRB) whose job is to protect participants, and care is overseen by licensed medical staff. You'll be told the known risks before you agree to anything, and you can stop at any time.
Will I get a placebo instead of the real treatment?+
Some studies compare a treatment against a placebo (an inactive version), and some don't. If this one does, the study team will explain your chances of receiving the active treatment before you decide. Nothing is hidden from you.
Do I have to stop taking my current medications?+
It depends on the study. Some let you stay on your current medications and some ask you to adjust them. Never stop a medication on your own — the study team will review everything with you first.
Does it cost anything? Will I be paid?+
The study treatment and study-related visits are provided at no cost to you. Some studies also pay for your time; the coordinator can tell you if this one does. You should never be asked to pay to take part.
Do I need insurance? Will anyone ask about my immigration status?+
No. You do not need health insurance to take part in a research study, and you will not be asked about your immigration status to join. Taking part is about whether you're a medical fit for the study.
What if English isn't my first language?+
You have the right to understand everything before you agree. Study sites can often provide materials or an interpreter in your language — you can ask the coordinator for one.
Is my information private?+
Yes. Your health information is only shared with the study sites you choose to be contacted by, and only to help match and enroll you. It is never sold, and you can ask us to delete it at any time.
Source: ClinicalTrials.gov · NCT06023589 · Locations: Alabama · Arizona · Arkansas · California · Georgia · Maryland · Massachusetts · Michigan · New Jersey · New York · North Carolina · Ohio · Oklahoma · South Carolina · Texas