Recruiting
Sponsor ID
D5180C00016

A Study to Investigate the Efficacy and Safety of Tezepelumab Compared With Placebo in Children 5 to < 12 Years Old With Severe AsthmaHORIZON

Sponsor ID
D5180C00016
Clinicaltrials.gov ID
NCT06023589
EUCTIS ID
N/A
EudraCT ID
N/A

Study Details

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
231
Additional Study Details

Protocol Summary

Primary Outcome Measures

Annualized severe asthma exacerbation rate (AAER)

Timeframe: From Baseline to Week 52

Secondary Outcome Measures

Change from baseline in pre-bronchodilator (pre-BD) forced expiratory volume in 1 second (FEV1) percent predicted normal (PN)

Timeframe: From Baseline to Week 52

AAER associated with allergic asthma

Timeframe: From Baseline to Week 52

Time to first severe asthma exacerbation

Timeframe: From Baseline to Week 52

Proportion of participants with ≥ 1 severe asthma exacerbation

Timeframe: From Baseline to Week 52

AAER associated with ER visit or hospitalisation

Timeframe: From Baseline to Week 52

Cumulative exposure to systemic corticosteroids for treatment of severe asthma exacerbations

Timeframe: From Baseline to Week 52

Change from baseline in Paediatric Asthma Quality of Life Questionnaire (PAQLQ-(S)-IA) total score

Timeframe: From Baseline to Week 52

Change from baseline in weekly mean daily Paediatric Asthma Symptom Observer (PASO) score

Timeframe: From Baseline to Week 52

Change from baseline in Asthma Control Questionnaire - Interviewer Administered (ACQ-IA) score

Timeframe: From Baseline to Week 52

Change from baseline in weekly mean rescue medication use

Timeframe: From Baseline to Week 52

Change from baseline in weekly mean number of night-time awakenings

Timeframe: From Baseline to Week 52

Change from baseline in blood eosinophil count

Timeframe: From Baseline to Week 52

Change from baseline in fractional exhaled nitric oxide (FeNO)

Timeframe: From Baseline to Week 52

Change from baseline in total serum IgE

Timeframe: From Baseline to Week 52

Change from baseline in pre-bronchodilator (pre-BD) peak expiratory flow (PEF)

Timeframe: From Baseline to Week 52

Number of asthma--related healthcare resource utilization (HRU)

Timeframe: From Baseline to Week 52

Number of participant/caregiver health-related absences

Timeframe: From Baseline to Week 52

Serum concentrations of tezepelumab

Timeframe: At Baseline, Week 4, Week 24, and Week 52

Incidence of anti-drug antibodies (ADAs)

Timeframe: At Baseline, and from time of first dose at Week 0 to end of study at week 64

Incidence of neutralising antibodies (nAbs)

Timeframe: At Baseline, and from time of first dose at Week 0 to end of study at week 64

Locations

Location
Status
Contact Us
Location
Research Site
Montgomery, Alabama, United States, 36106
Status
Recruiting
Location
Research Site
Phoenix, Arizona, United States, 85016
Status
Recruiting
Location
Research Site
Little Rock, Arkansas, United States, 72202
Status
Withdrawn
Location
Research Site
La Jolla, California, United States, 92037
Status
Recruiting
Location
Research Site
Long Beach, California, United States, 90806
Status
Recruiting
Location
Research Site
Orange, California, United States, 92868
Status
Withdrawn
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