Evaluating tezepelumab for severe asthma in children aged 5 to under 12

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase-3 clinical trial investigates the efficacy and safety of tezepelumab, a monoclonal antibody, in children aged 5 to less than 12 years with severe uncontrolled asthma. Participants will undergo a screening period followed by a 52-week double-blind treatment phase where they will receive either tezepelumab or a placebo via subcutaneous injections. After the treatment phase, there will be a 12-week follow-up period, with an optional extension for those who qualify to continue receiving tezepelumab. The study aims to provide insights into the effectiveness of this treatment in managing severe asthma in pediatric patients.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Written informed consent from (ICF) at least one parent/caregiver (as per local guidelines) and accompanying informed assent from the participant (where the participant is able to provide assent) prior to admission to the study.
2. Participants must be 5 to \< 12 years of age, at the time of signing the assent form (as applicable per local guidelines) and their caregivers signing the ICF and at Visit 3.
3. Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1.
4. Documented physician-prescribed treatment with a total daily dose of either medium or high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
5. Documented treatment with at least one additional maintenance asthma controller medication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinic antagonist) for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
6. Supportive evidence of asthma as documented by one of the following:

   1. Post-BD (albuterol/salbutamol) responsiveness of FEV1 ≥ 10% during Screening (15 to 30 min after administration of 4 puffs of albuterol/salbutamol with a maximum of 12 puffs of reliever medication only if tolerated by the participant) at either Visit 1 or Visit 2.

      If (a) is not achieved at Visit 1 or Visit 2, historical documentation by any of the below prior to Visit 1:
   2. Post-BD responsiveness of FEV1 ≥ 10%.
   3. Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
   4. PEF average daily diurnal variability \> 13% over a 2-week period.
   5. Variability of FEV1 ≥ 12% between any two clinical visits.
   6. Positive exercise challenge test (defined as a fall in FEV1 of \> 12%).
   7. FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
7. 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.
8. Pre-BD FEV1 \>50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 at either Visit 1 or Visit 2.
9. Evidence of uncontrolled asthma, with at least 1 of the below criteria:

   1. ACQ-IA score ≥ 1.5 at least once during Screening/Run-in, including Visit 3 (prior to Randomisation) for participants ≥ 6 years old at Screening.
   2. Use of reliever medication, other than as a preventive for exercise induced bronchospasm, on 3 or more days per week for at least 1 week during the Screening/Run-in period.
   3. Sleep awakening due to asthma symptoms requiring use of reliever medication at least once during the Screening/Run-in period.
   4. Asthma symptoms 3 or more days per week in at least 1 week during the Screening/Run-in period.
10. Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).

Exclusion Criteria:

1. History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, or chronic rhinosinusitis with nasal polyposis.
2. History of any clinically significant disease or disorder other than asthma which, in the opinion of the investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study.
3. History of a clinically significant deterioration in asthma or asthma exacerbation including those requiring use of systemic corticosteroids or increase in the maintenance dose of oral corticosteroids within 30 days prior to Visit 1.
4. Change in ICS dose within 1 month prior to Visit 1.
5. History of a life-threatening asthma exacerbation resulting in a hypoxic seizure or requiring intubation.

Where it's running

• Research Site
  Montgomery, Alabama, United States Recruiting
• Research Site
  Phoenix, Arizona, United States Recruiting
• Research Site
  Long Beach, California, United States Recruiting
• Research Site
  San Diego, California, United States Recruiting
• Research Site
  Atlanta, Georgia, United States Recruiting
• Research Site
  Baltimore, Maryland, United States Recruiting

+97 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Real-world use of tezepelumab for chronic rhinosinusitis with nasal polyps in Russia

  This study will see how tezepelumab works in adults in Russia who have chronic rhinosinusitis with nasal polyps, with or without asthma.

  Recruiting at 10 sites AstraZeneca · Kazan' and 9 other locations · NCT07399665

• Chronic Respiratory Disease Participant Engagement

  This study tests whether adults with long-term lung conditions can get comfortable with a clinical trials unit and research team before joining future trials.

  Recruiting Richmond Pharmacology Limited · London · NCT07924462

• HB0056 in adults with moderate to severe asthma

  This study tests HB0056 versus a placebo to see if it helps adults with moderate to severe asthma reduce rescue inhaler use and improve symptoms.

  Recruiting at 2 sites Phase 1/2 Shanghai Huaota Biopharmaceutical Co., Ltd. · Beijing and 1 other locations · NCT07899996

• Tilrekimig (PF-07275315) for Severe Asthma: Aimed at Adults with Frequent Exacerbations

  This study tests whether tilrekimig helps people with severe asthma who have had multiple flare-ups in the past year, by comparing it to a placebo given every four weeks.

  Recruiting at 4 sites Phase 3 Pfizer · River Forest, Illinois and 11 other locations · NCT07869043

• Inhaled CHF10136 safety and pharmacokinetics in healthy adults and adults with asthma

  This first-in-human study tests inhaled CHF10136 to see if it is safe and well tolerated, how it behaves in the body, and how it affects adults with asthma compared with placebo.

  Recruiting Phase 1 Chiesi Farmaceutici S.p.A. · Leeds and 2 other locations · NCT07851623

• Biologics for Type 2 Inflammation in Asthma and COPD in Real World

  This real-world study tests whether six biologic drugs can reduce flare-ups and improve symptoms in adults with asthma or COPD treated in routine care in China.

  Recruiting Shanghai Pulmonary Hospital, Shanghai, China · Shanghai, Shanghai Municipality · NCT07823842

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.