A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

Status: Recruiting
Location: See all (205) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Provision of signed and dated written informed consent prior to any study-specific procedures.

• Adults aged 18-75, inclusive when signing the informed consent.

• Documented physician-diagnosis of asthma for at least 12 months.

• Treated with medium or high dose ICS in combination with LABA.

• Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .

• Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.

• Documented exacerbation history in the last 12 months and biomarker requirements of:

∙ 2 severe exacerbations OR

‣ 1 severe exacerbation and:

• (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb

• Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.

• Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.

⁃ Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Locations
United States
California
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Bakersfield
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Huntington Beach
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La Mesa
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Newport Beach
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San Jose
Delaware
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Wilmington
Florida
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Cutler Bay
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Hialeah
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Leesburg
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Miami
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Miami
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Miami
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Orlando
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Palmetto Bay
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Tampa
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Winter Park
Iowa
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West Des Moines
Idaho
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Boise
Indiana
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Indianapolis
Kentucky
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Louisville
Maryland
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White Marsh
Michigan
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Farmington Hills
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Warren
Missouri
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St Louis
North Carolina
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Asheville
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Huntersville
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Kings Mountain
Nebraska
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Bellevue
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Grand Island
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Omaha
New Jersey
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Toms River
New York
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Maspeth
Ohio
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Toledo
Oklahoma
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Edmond
Oregon
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Grants Pass
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Medford
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Portland
Pennsylvania
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Dubois
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Philadelphia
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Smithfield
South Carolina
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Rock Hill
Tennessee
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Knoxville
Texas
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Austin
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Forney
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Kingwood
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Tyler
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Victoria
Utah
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Roy
Washington
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Bellingham
Wisconsin
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Milwaukee
West Virginia
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Kingwood
Other Locations
Argentina
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Caba
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Ciudad De Buenos Aires
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Ciudad De Buenos Aires
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La Plata
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Mendoza
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Rosario
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San Miguel De Tucumán
Brazil
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Caxias Do Sul
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Criciúma
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Porto Alegre
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Porto Alegre
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Salvador
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Santo André
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São José Do Rio Preto
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São Paulo
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São Paulo
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Sorocaba
Chile
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Curicó
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Quillota
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Santiago
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Santiago
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Santiago
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Temuco
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Viña Del Mar
China
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Baotou
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Changchun
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Chengdu
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Chongqing
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Guangzhou
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Haikou
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Hefei
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Hohhot
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Huizhou
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Qingdao
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Shanghai
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Shanghai
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Shanghai
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Shenzhen
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Wenzhou
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Xuzhou
France
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Brest
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Créteil
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Lyon
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Marseille
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Pessac
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Strasbourg
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Suresnes
Greece
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Athens
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Athens
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Ioannina
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Pátrai
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Thessaloniki
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Thessaloniki
Hungary
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Balassagyarmat
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Budapest
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Budapest
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Debrecen
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Gödöllő
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Pécs
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Törökbálint
India
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Belagavi
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Coimbatore
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Dehradun
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Delhi
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Faridabad
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Gūrgaon
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Kochi
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Lucknow
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New Delhi
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Vadodara
Israel
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Haifa
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Jerusalem
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Kfar Saba
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Ramat Gan
Italy
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Catania
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Foggia
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Genoa
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Roma
Japan
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Fukuoka
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Ginowan-shi
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Ishinomaki
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Kawaguchi-shi
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Kiyose-shi
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Kobe
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Meguro-ku
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Miura
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Sapporo
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Sapporo
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Takamatsu
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Ube
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Yokohama
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Yokohama
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Yokohama
Peru
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Lima
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Lima
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Lima
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Lima
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Lima
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Lima
Philippines
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Iloilo City
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Las Piñas
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Lipa City
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Manadaluyong City
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Quezon City
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Roxas City
Republic of Korea
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Cheongju-si
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Daegu
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
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Seoul
South Africa
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Benoni
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Brackenfell
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Cape Town
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Durban
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Emkhomazi
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Somerset West
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Tygervalley
Spain
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Barcelona
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Barcelona
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Madrid
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Málaga
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Mérida
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Patraix
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Santander
Taiwan
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Kaohsiung City
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New Taipei City
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Taichung
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Taichung
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Taipei
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Taipei
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Taipei
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Taipei
Thailand
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Bangkok
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Chanthaburi
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Chiang Rai
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Chon Buri
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Khon Kaen
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Nakhon Sri Thammarat
Turkey
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Ankara
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Bursa
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Gaziantep
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Istanbul
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Kayseri
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Mersin
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Yüreğir
Viet Nam
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Da Nang
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Haiphong
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Hanoi
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Ho Chi Minh City
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Ho Chi Minh City
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Huế
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-03-26
Estimated Completion Date: 2028-03-16
Participants
Target number of participants: 540
Treatments
Experimental: Tozorakimab Dose 1
Dosing subcutaneously tozorakimab Dose 1
Experimental: Tozorakimab Dose 2
Dosing subcutaneously tozorakimab Dose 2 and placebo
Placebo_comparator: Placebo
Dosing subcutaneously with equivalent volume to tozorakimab
Related Therapeutic Areas
Sponsors
Leads: AstraZeneca

This content was sourced from clinicaltrials.gov

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