Phase
Condition
Asthma
Treatment
Tezepelumab
Placebo
Clinical Study ID
Ages 5-11 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Written informed consent from (ICF) at least one parent/caregiver (as per localguidelines) and accompanying informed assent from the participant (where theparticipant is able to provide assent) prior to admission to the study.
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 atVisit 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 mediumor high dose, for at least 3 months with stable dose ≥ 1 month prior to Visit 1.
Documented treatment with at least one additional maintenance asthma controllermedication is required according to local guidelines and standard of care; (long-acting beta agonist, leukotriene receptor antagonist, long-acting muscarinicantagonist) 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 amaximum of 12 puffs of reliever medication only if tolerated by theparticipant) at either Visit 1 or Visit 2.If (a) is not achieved at Visit 1 or Visit 2, historical documentation by anyof the below prior to Visit 1:
Post-BD responsiveness of FEV1 ≥ 10%.
Positive methacholine challenge defined as provocative concentration (PC20) of ≤ 16 mg/mL.
PEF average daily diurnal variability > 13% over a 2-week period.
Variability of FEV1 ≥ 12% between any two clinical visits.
Positive exercise challenge test (defined as a fall in FEV1 of > 12%).
FeNO ≥ 20 ppb despite confirmed ICS maintenance therapy.
History of at least 2 severe asthma exacerbation events OR 1 severe asthmaexacerbation event resulting in hospitalisation within 12 months prior to Visit 1.
Pre-BD FEV1 >50% and ≤ 95%PN OR FEV1/forced vital capacity (FVC) ratio ≤ 0.85 ateither Visit 1 or Visit 2.
Evidence of uncontrolled asthma, with at least 1 of the below criteria:
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.
Use of reliever medication, other than as a preventive for exercise inducedbronchospasm, on 3 or more days per week for at least 1 week during theScreening/Run-in period.
Sleep awakening due to asthma symptoms requiring use of reliever medication atleast once during the Screening/Run-in period.
Asthma symptoms 3 or more days per week in at least 1 week during theScreening/Run-in period.
Body weight ≥ 16 kg at Visit 1 (Screening) and Visit 3 (Randomisation).
Exclusion
Exclusion Criteria:
History of vocal cord dysfunction, cystic fibrosis, primary ciliary dyskinesia, orchronic rhinosinusitis with nasal polyposis.
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 becauseof participation in the study, or influence the results or the participant's abilityto participate in the study.
History of a clinically significant deterioration in asthma or asthma exacerbationincluding those requiring use of systemic corticosteroids or increase in themaintenance dose of oral corticosteroids within 30 days prior to Visit 1.
Change in ICS dose within 1 month prior to Visit 1.
History of a life-threatening asthma exacerbation resulting in a hypoxic seizure orrequiring intubation.
Study Design
Study Description
Connect with a study center
Research Site
Buenos Aires, C1121ABE
ArgentinaActive - Recruiting
Research Site
Buenos Aires 3435910, C1122
ArgentinaActive - Recruiting
Research Site
CABA, C1028AAP
ArgentinaTerminated
Research Site
Caba, 1426
ArgentinaActive - Recruiting
Research Site
Florida, B1602DQD
ArgentinaActive - Recruiting
Research Site
Lanus, B1824KAJ
ArgentinaActive - Recruiting
Research Site
Lobos, 7240
ArgentinaActive - Recruiting
Research Site
Mendoza, M5500CCG
ArgentinaActive - Recruiting
Research Site
Quilmes, B1878FNR
ArgentinaTerminated
Research Site
Rosario, 2000
ArgentinaActive - Recruiting
Research Site
Blumenau, 89030-101
BrazilActive - Recruiting
Research Site
Curitiba, 80060-240
BrazilActive - Recruiting
Research Site
Salvador, 40060-330
BrazilSite Not Available
Research Site
Sao Paulo, 05403 000
BrazilActive - Recruiting
Research Site
Sorocaba, 18040-425
BrazilActive - Recruiting
Research Site
São Paulo, 05430-010
BrazilActive - Recruiting
Research Site
São Paulo 3448439, 04024-002
BrazilActive - Recruiting
Research Site
Edmonton, Alberta T6G 1C9
CanadaActive - Recruiting
Research Site
Burlington, Ontario L7L 6W6
CanadaActive - Recruiting
Research Site
Hamilton, Ontario L8S 1G5
CanadaActive - Recruiting
Research Site
Windsor, Ontario N8X 2G1
CanadaActive - Recruiting
Research Site
Montreal, Quebec H4A 3J1
CanadaActive - Recruiting
Research Site
Beijing, 100191
ChinaActive - Recruiting
Research Site
Changchun, 130021
ChinaActive - Recruiting
Research Site
Lanzhou, 730000
ChinaActive - Recruiting
Research Site
Nanjing, 210008
ChinaActive - Recruiting
Research Site
Shanghai, 200062
ChinaActive - Recruiting
Research Site
Shanghai 1796236, 200127
ChinaSite Not Available
Research Site
Shenyang, 110004
ChinaActive - Recruiting
Research Site
Shenzhen, 518026
ChinaActive - Recruiting
Research Site
Wuxi, 214023
ChinaActive - Recruiting
Research Site
Bogotá,
ColombiaSite Not Available
Research Site
Bogotá 3688689,
ColombiaSite Not Available
Research Site
Medellín, 050034
ColombiaSite Not Available
Research Site
Brest, 29609
FranceActive - Recruiting
Research Site
Bron, 69500
FranceSuspended
Research Site
Créteil, 94010
FranceActive - Recruiting
Research Site
Marseille, 13005
FranceActive - Recruiting
Research Site
Paris, 75015
FranceActive - Recruiting
Research Site
Paris 2988507, 75019
FranceActive - Recruiting
Research Site
Rouen, 76031
FranceActive - Recruiting
Research Site
Vandœuvre-lès-Nancy, 54511
FranceActive - Recruiting
Research Site
Debrecen, 4031
HungaryActive - Recruiting
Research Site
Szeged, 6720
HungaryActive - Recruiting
Research Site
Szigetvár, 7900
HungaryActive - Recruiting
Research Site
Genova, 16147
ItalyActive - Recruiting
Research Site
Pavia, 27100
ItalyActive - Recruiting
Research Site
Roma, 00165
ItalySite Not Available
Research Site
Fukuoka, 813-0017
JapanActive - Recruiting
Research Site
Fukuoka 1863967, 811-1394
JapanActive - Recruiting
Research Site
Fukuoka-shi, 811-1394
JapanActive - Recruiting
Research Site
Fukuyama, 720-8520
JapanActive - Recruiting
Research Site
Funabashi-shi, 273-8588
JapanActive - Recruiting
Research Site
Nara, 630-8581
JapanActive - Recruiting
Research Site
Nara 1855612, 630-8054
JapanActive - Recruiting
Research Site
Odawara, 250-0055
JapanActive - Recruiting
Research Site
Saga, 840-8571
JapanActive - Recruiting
Research Site
Shimotsuga-gun, 321-0293
JapanActive - Recruiting
Research Site
Yokohama, 223-0059
JapanSite Not Available
Research Site
Ōtsu, 520-0804
JapanActive - Recruiting
Research Site
Seongnam-Si, 463-712
Korea, Republic ofActive - Recruiting
Research Site
Seoul, 03722
Korea, Republic ofActive - Recruiting
Research Site
Chihuahua City, 31000
MexicoActive - Recruiting
Research Site
Guadalajara, 44100
MexicoActive - Recruiting
Research Site
Mexico City, 06100
MexicoSite Not Available
Research Site
Mexico City 3530597, 06760
MexicoSite Not Available
Research Site
Veracruz, 91910
MexicoActive - Recruiting
Research Site
Amsterdam, 1105 AZ
NetherlandsActive - Recruiting
Research Site
Rotterdam, 3015 GD
NetherlandsActive - Recruiting
Research Site
Iloilo,
PhilippinesActive - Recruiting
Research Site
Iloilo City, 5000
PhilippinesActive - Recruiting
Research Site
Las Piñas, 1740
PhilippinesActive - Recruiting
Research Site
Quezon, 1100
PhilippinesActive - Recruiting
Research Site
Santa Rosa, 4026
PhilippinesActive - Recruiting
Research Site
Lodz, 90-329
PolandActive - Recruiting
Research Site
Tarnów, 33-100
PolandActive - Recruiting
Research Site
Łódź, 90-302
PolandActive - Recruiting
Research Site
Bucharest, 050159
RomaniaActive - Recruiting
Research Site
Bucharest 683506, 020395
RomaniaActive - Recruiting
Research Site
Bellville, 7531
South AfricaActive - Recruiting
Research Site
Cape Town, 7925
South AfricaActive - Recruiting
Research Site
Durban, 4001
South AfricaActive - Recruiting
Research Site
Durban 1007311, 4001
South AfricaActive - Recruiting
Research Site
Middelburg, 1055
South AfricaCompleted
Research Site
Thabazimbi, 0380
South AfricaSite Not Available
Research Site
Vereeniging, 1935
South AfricaActive - Recruiting
Research Site
Welkom, 9460
South AfricaActive - Recruiting
Research Site
Seongnam-si, 13496
South KoreaSite Not Available
Research Site
Seongnam-si 1897000, 13496
South KoreaSite Not Available
Research Site
Seoul, 03722
South KoreaActive - Recruiting
Research Site
Seoul 1835848, 03181
South KoreaActive - Recruiting
Research Site
Badalona, 08916
SpainActive - Recruiting
Research Site
Barcelona, 08035
SpainActive - Recruiting
Research Site
Esplugues de Llobregat (Barc), 08950
SpainActive - Recruiting
Research Site
Madrid, 28009
SpainActive - Recruiting
Research Site
Sabadell, 08208
SpainActive - Recruiting
Research Site
Valencia, 46010
SpainActive - Recruiting
Research Site
Valencia 2509954, 46010
SpainActive - Recruiting
Research Site
Villarreal, 12540
SpainActive - Recruiting
Research Site
Bangkok, 10330
ThailandSite Not Available
Research Site
Bangkoknoi, 10700
ThailandSite Not Available
Research Site
Chiang Mai, 50200
ThailandSite Not Available
Research Site
Muang, 40002
ThailandActive - Recruiting
Research Site
Bursa, 16059
Turkey (Türkiye)Active - Recruiting
Research Site
Istanbul, 34899
Turkey (Türkiye)Active - Recruiting
Research Site
Izmir, 35210
Turkey (Türkiye)Active - Recruiting
Research Site
Yenimahalle, 06500
Turkey (Türkiye)Active - Recruiting
Research Site
Chernivtsi, 58002
UkraineActive - Recruiting
Research Site
Ivano-Frankivsk, 76000
UkraineActive - Recruiting
Research Site
Kyiv, 03038
UkraineActive - Recruiting
Research Site
Kyiv 703448, 03038
UkraineActive - Recruiting
Research Site
Birmingham, B4 6NH
United KingdomActive - Recruiting
Research Site
Bradford, BD9 6RJ
United KingdomActive - Recruiting
Research Site
Bristol, BS2 8BJ
United KingdomActive - Recruiting
Research Site
Glasgow, G3 8SJ
United KingdomSite Not Available
Research Site
Leicester, LE1 5WW
United KingdomActive - Recruiting
Research Site
London, SE5 9RS
United KingdomActive - Recruiting
Research Site
Nottingham, NG7 2UH
United KingdomActive - Recruiting
Research Site
Stoke-on-Trent, ST4 6QG
United KingdomActive - Recruiting
Research Site
Montgomery, Alabama 36106
United StatesActive - Recruiting
Research Site
Phoenix, Arizona 85016
United StatesActive - Recruiting
Research Site
Little Rock, Arkansas 72202
United StatesSite Not Available
Research Site
La Jolla, California 92037
United StatesActive - Recruiting
Research Site
Long Beach, California 90806
United StatesActive - Recruiting
Research Site
Orange, California 92868
United StatesSite Not Available
Research Site
San Diego, California 92123
United StatesActive - Recruiting
Research Site
Atlanta, Georgia 30322
United StatesActive - Recruiting
Research Site
Savannah, Georgia 31406
United StatesTerminated
Research Site
Baltimore, Maryland 21287
United StatesSite Not Available
Research Site
Boston, Massachusetts 02115
United StatesActive - Recruiting
Research Site
Boston 4930956, Massachusetts 6254926 02115
United StatesActive - Recruiting
Research Site
Ann Arbor, Michigan 48105
United StatesTerminated
Research Site
Detroit, Michigan 48201
United StatesActive - Recruiting
Research Site
Northfield, New Jersey 08225
United StatesActive - Recruiting
Research Site
Hawthorne, New York 10532
United StatesActive - Recruiting
Research Site
Schenectady, New York 12304
United StatesSite Not Available
Research Site
Staten Island, New York 10305
United StatesActive - Recruiting
Research Site
Chapel Hill, North Carolina 27514
United StatesActive - Recruiting
Research Site
Cincinnati, Ohio 45229-3039
United StatesActive - Recruiting
Research Site
Cleveland, Ohio 44106
United StatesActive - Recruiting
Research Site
Toledo, Ohio 43617
United StatesActive - Recruiting
Research Site
Oklahoma City, Oklahoma 73120
United StatesActive - Recruiting
Research Site
Columbia, South Carolina 29203
United StatesSite Not Available
Research Site
Coppell, Texas 75019
United StatesTerminated
Research Site
Dallas, Texas 75246
United StatesActive - Recruiting
Research Site
Frisco, Texas 75034
United StatesSite Not Available
Research Site
Houston, Texas 77030
United StatesSite Not Available
Research Site
San Antonio, Texas 78249
United StatesActive - Recruiting
Research Site
Temple, Texas 76508
United StatesSite Not Available

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