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PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Tezepelumab for Asthma

To assess the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT06023589 · AstraZeneca · enrollment listed as 231

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tezepelumab, or Placebo. The registry lists allocation as randomized. To assess the how well it works 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.

They plan to enroll about 231 people at 131 sites. Taking part typically means an infusion or injection of a biologic plus check-ins.

Official title (unrewritten)

A Multicentre, Randomised, Double-Blind, Parallel-Group Placebo-Controlled, Phase 3, Efficacy and Safety Study of Tezepelumab in 5 to < 12 Year Old Children With Severe Uncontrolled Asthma (HORIZON)

Interventions: Tezepelumab, Placebo

Primary outcome (registry wording): Annualized severe asthma exacerbation rate (AAER)

Who it is for (from inclusion criteria)

  • Ages 5 Years to 11 Years
  • 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
  • Documented physician diagnosis of severe asthma confirmed and evaluated for at least 6 months prior to Visit 1
  • 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
  • Supportive evidence of asthma as documented by one of the following:
  • 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:
  • Post-BD responsiveness of FEV1 ≥ 10%

Public study contact (from the registry)

AstraZeneca Clinical Study Information Center

1-877-240-9479

information.center@astrazeneca.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

131 listed

+ 102 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06023589 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06023589?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06023589?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary