Phase 3 Asthma Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- The child must be between 2 and under 6 years of age.
- The child must have a diagnosis of asthma or recurring severe wheezing episodes that have not been well controlled by inhaled corticosteroid (preventer) medication used regularly for at least 3 months, with the same dose stable for at least 1 month before the first screening visit.
- The child must meet at least one major risk factor for asthma (either a doctor-diagnosed skin condition called atopic dermatitis, or a blood test showing allergy to at least one airborne allergen), OR meet at least two minor risk factors (wheezing that happens when the child does not have a cold; a blood test showing a higher-than-normal level of a certain immune cell called eosinophils; or a blood test showing allergy to milk, eggs, or peanuts).
- The child's parent, caregiver, or legal guardian must be willing and able to attend clinic visits and follow all study procedures.
- The child's parent, caregiver, or legal guardian must be able to understand what the study involves.
- The child's parent, caregiver, or legal guardian must be able to understand and fill in study questionnaires, with the child's input where appropriate.
- The child must weigh more than 5 kg and less than 30 kg at the screening and randomisation visits.
- The child's parent, caregiver, or legal guardian must be able to give signed informed consent to participate.
Who may not be able to join:
- Children with severe asthma who have been taking oral or systemic (whole-body) steroid medication continuously for more than 1 month at the time of screening.
- Children who have previously had a serious allergic reaction or anaphylaxis to a biologic (a type of medicine made from living cells) or any of its ingredients.
- Children who were born prematurely before 34 weeks of pregnancy.
- Children who have another long-term lung condition that affects lung function, such as cystic fibrosis or bronchopulmonary dysplasia, or who needed oxygen for more than 5 days as a newborn.
- Children who have had a life-threatening asthma attack, for example one that required a breathing tube.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: 800-633-1610
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Part A: Annualized rate of severe asthma exacerbations during the 52-week treatment period; Part B: Incidence of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), adverse events of special interest (AESIs), and AEs leading to permanent treatment discontinuation
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.