Recruiting

Testing a new injectable treatment for hard-to-control asthma in young children

Plain-English translation of NCT06191315 on ClinicalTrials.gov ↗ · Source last updated March 2026 · Translation generated June 2026 · How we translate trials

Phase 3 — Testing in thousands of people, comparing the treatment against what doctors currently use. This is the last big step before approval.

What is this trial?

This study is testing a medication called to see if it can help young children (ages 2 to 6) whose asthma is difficult to control even when they're taking inhaled steroid medications regularly. The medication is given as an injection under the skin. Researchers want to learn whether this treatment can reduce asthma attacks and wheezing, and whether it is safe for this age group over a long period of time.

Many young children struggle to manage their asthma even when taking standard steroid medications, leading to frequent asthma attacks and breathing problems. This medication has helped older children and adults with similar asthma challenges, but it hasn't been thoroughly tested or approved yet for very young children, so this study aims to find out if it works safely for this age group.

Do you qualify?

You likely qualify if…

your child is between 2 and 6 years old
your child has been diagnosed with asthma or recurrent severe wheezing that isn't well controlled
your child has been taking inhaled steroid medications regularly (at least low-dose) for at least 1 month before enrolling
your child has at least one sign of allergic asthma, such as eczema, an allergy to airborne allergens, or a food allergy
your child weighs between 11 and 66 pounds at the time of screening
you are able to bring your child to regular clinic visits and follow study instructions

You likely don't qualify if…

your child needs to take oral or systemic steroid medications continuously to control asthma
your child has a known serious allergic reaction to biologic medications
your child was born before 34 weeks of pregnancy
your child has other chronic lung diseases such as cystic fibrosis or bronchopulmonary dysplasia
your child has a history of life-threatening asthma that required being placed on a breathing machine

What participation looks like

If your child is accepted into this study, you will randomly receive either the new medication or a placebo (a shot that looks the same but contains no active medicine). Your child will receive injections under the skin as directed by the study protocol. Over the course of about 2 years (120 weeks), you'll attend multiple clinic visits where doctors will check your child's asthma control, ask about any breathing problems, and monitor for any side effects. The study team will teach you how to give the injections and will be available to answer your questions throughout the trial.

AI-generated summary from trial data · Jun 14, 2026 · Not medical advice

Testing a new injectable treatment for hard-to-control asthma in young children

What is this trial?

Do you qualify?

What participation looks like

Trial locations(74 sites)