A Randomised, Double-blind, Placebo-controlled, Parallel Group, Multicentre, Phase III Study to Evaluate the Efficacy and Safety of Tezepelumab in Adult Participants With Moderate to Very Severe Chronic Obstructive Pulmonary Disease

Status: Recruiting
Location: See all (261) locations...
Intervention Type: Biological, Other
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Eligibility
Participation Requirements
Sex: All
Minimum Age: 40
Maximum Age: 80
Healthy Volunteers: f
View:

• ≥40 to ≤80 years old

• COPD diagnosis ≥1 year,

• Post-BD FEV1 ≥ 20% and ≤ 70% PN, FEV1/FVC \<0.70 at screening

• Triple (ICS+LABA+LAMA) or dual inhaled COPD therapy, if triple therapy is considered not appropriate, ≥3 consecutive months prior to V1

• ≥2 moderate or ≥1 severe COPD exacerbations in the prior year; At least 1 of 2 moderate exacerbations must require the use of systemic corticosteroids. At least one of the previous exacerbations should be confirmed to have occurred while the participant was on triple or dual inhaled maintenance therapy

• EOS ≥ 150 cells/μL during screening

• CAT ≥15 at screening

• Former or current smokers ≥10 pack-years

Locations
United States
Alabama
Research Site
RECRUITING
Cullman
Arizona
Research Site
RECRUITING
Phoenix
Research Site
NOT_YET_RECRUITING
Scottsdale
California
Research Site
WITHDRAWN
Inglewood
Research Site
RECRUITING
Los Angeles
Research Site
NOT_YET_RECRUITING
Palo Alto
Research Site
RECRUITING
Redding
Research Site
RECRUITING
San Diego
Connecticut
Research Site
RECRUITING
New Britain
Delaware
Research Site
RECRUITING
Wilmington
Florida
Research Site
NOT_YET_RECRUITING
Bay Pines
Research Site
RECRUITING
Boynton Beach
Research Site
RECRUITING
Clearwater
Research Site
RECRUITING
Fleming Island
Research Site
RECRUITING
Jacksonville
Research Site
RECRUITING
Leesburg
Research Site
WITHDRAWN
Margate
Research Site
RECRUITING
Miami
Research Site
RECRUITING
Miami
Research Site
RECRUITING
Miami Lakes
Research Site
RECRUITING
Ocala
Research Site
RECRUITING
Palmetto Bay
Research Site
RECRUITING
Winter Park
Georgia
Research Site
RECRUITING
Adairsville
Research Site
RECRUITING
Atlanta
Research Site
RECRUITING
Cordele
Research Site
NOT_YET_RECRUITING
Decatur
Research Site
WITHDRAWN
Fort Eisenhower
Research Site
RECRUITING
Savannah
Indiana
Research Site
RECRUITING
Evansville
Research Site
RECRUITING
Indianapolis
Research Site
RECRUITING
Indianapolis
Kansas
Research Site
RECRUITING
Kansas City
Kentucky
Research Site
RECRUITING
Bowling Green
Research Site
RECRUITING
Owensboro
Maryland
Research Site
NOT_YET_RECRUITING
Baltimore
Research Site
RECRUITING
Potomac
Michigan
Research Site
NOT_YET_RECRUITING
Ann Arbor
Minnesota
Research Site
RECRUITING
Minneapolis
Missouri
Research Site
RECRUITING
Hannibal
North Carolina
Research Site
RECRUITING
Charlotte
Research Site
WITHDRAWN
Fayetteville
Oklahoma
Research Site
RECRUITING
Oklahoma City
Research Site
RECRUITING
Tulsa
Oregon
Research Site
WITHDRAWN
Grants Pass
South Carolina
Research Site
RECRUITING
Anderson
Research Site
RECRUITING
Columbia
Research Site
RECRUITING
Gaffney
Research Site
RECRUITING
Spartanburg
Research Site
RECRUITING
Union
South Dakota
Research Site
RECRUITING
Rapid City
Tennessee
Research Site
RECRUITING
Knoxville
Texas
Research Site
RECRUITING
Boerne
Research Site
RECRUITING
El Paso
Research Site
RECRUITING
Houston
Research Site
RECRUITING
Houston
Research Site
RECRUITING
Lewisville
Research Site
RECRUITING
Mckinney
Research Site
RECRUITING
Mesquite
Virginia
Research Site
RECRUITING
Williamsburg
Vermont
Research Site
RECRUITING
Colchester
Washington
Research Site
RECRUITING
Everett
Other Locations
Argentina
Research Site
RECRUITING
Alberdi
Research Site
RECRUITING
Buenos Aires
Research Site
RECRUITING
Ciudad De Buenos Aires
Research Site
RECRUITING
Florida
Research Site
RECRUITING
La Plata
Research Site
RECRUITING
La Plata
Research Site
RECRUITING
Mar Del Plata
Research Site
RECRUITING
Mendoza
Research Site
RECRUITING
Quilmes
Research Site
RECRUITING
Rosario
Research Site
RECRUITING
San Fernando
Research Site
RECRUITING
San Juan Bautista
Australia
Research Site
RECRUITING
Coffs Harbour
Research Site
RECRUITING
Frankston
Research Site
WITHDRAWN
Garran
Research Site
RECRUITING
Nedlands
Research Site
NOT_YET_RECRUITING
New Lambton
Research Site
RECRUITING
Spearwood
Research Site
WITHDRAWN
Wollongong
Research Site
RECRUITING
Woodville South
Belgium
Research Site
RECRUITING
Genk
Research Site
RECRUITING
Ghent
Research Site
RECRUITING
Jette
Research Site
RECRUITING
Leuven
Research Site
RECRUITING
Mechelen
Research Site
RECRUITING
Namur
Bulgaria
Research Site
RECRUITING
Dupnitsa
Research Site
RECRUITING
Haskovo
Research Site
WITHDRAWN
Lovech
Research Site
RECRUITING
Pleven
Research Site
RECRUITING
Plovdiv
Research Site
WITHDRAWN
Rousse
Research Site
RECRUITING
Rousse
Research Site
RECRUITING
Sofia
Research Site
RECRUITING
Sofia
Research Site
RECRUITING
Sofia
Research Site
WITHDRAWN
Sofia
Research Site
RECRUITING
Stara Zagora
Research Site
WITHDRAWN
Varna
Research Site
RECRUITING
Veliko Tanovo
Research Site
RECRUITING
Veliko Tarnovo
Research Site
RECRUITING
Vidin
Research Site
RECRUITING
Yambol
Colombia
Research Site
NOT_YET_RECRUITING
Armenia
Research Site
NOT_YET_RECRUITING
Barranquilla
Research Site
NOT_YET_RECRUITING
Bogotá
Research Site
NOT_YET_RECRUITING
Cali
Research Site
NOT_YET_RECRUITING
Ibagué
Research Site
NOT_YET_RECRUITING
Manizales
Research Site
NOT_YET_RECRUITING
Medellín
Research Site
NOT_YET_RECRUITING
Medellín
Denmark
Research Site
RECRUITING
Aalborg
Research Site
RECRUITING
Hvidovre
Research Site
RECRUITING
Næstved
Research Site
RECRUITING
Odense C
Research Site
RECRUITING
Vejle
France
Research Site
RECRUITING
Brest
Research Site
RECRUITING
Lyon
Research Site
RECRUITING
Marseille
Research Site
RECRUITING
Montpellier
Research Site
RECRUITING
Paris
Research Site
RECRUITING
Paris
Research Site
RECRUITING
Pessac
Research Site
RECRUITING
Saint-herblain
Greece
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Athens
Research Site
RECRUITING
Heraklion
Research Site
RECRUITING
Ioannina
Research Site
RECRUITING
Pátrai
Research Site
RECRUITING
Thessaloniki
Research Site
RECRUITING
Thessaloniki
Hong Kong Special Administrative Region
Research Site
RECRUITING
Hong Kong
Research Site
NOT_YET_RECRUITING
Hong Kong
Hungary
Research Site
RECRUITING
Budapest
Research Site
RECRUITING
Debrecen
Research Site
RECRUITING
Edelény
Research Site
RECRUITING
Gödöllő
Research Site
RECRUITING
Hatvan
Research Site
RECRUITING
Mosonmagyaróvár
Research Site
RECRUITING
Nyíregyháza-sóstóhegy
Research Site
RECRUITING
Törökbálint
Israel
Research Site
RECRUITING
Ashkelon
Research Site
RECRUITING
Haifa
Research Site
RECRUITING
Jerusalem
Research Site
RECRUITING
Jerusalem
Research Site
RECRUITING
Kfar Saba
Research Site
RECRUITING
Ramat Gan
Research Site
RECRUITING
Rehovot
Research Site
RECRUITING
Tel Aviv
Japan
Research Site
RECRUITING
Akashi-shi
Research Site
RECRUITING
Chikushino-shi
Research Site
RECRUITING
Chiyoda-ku
Research Site
RECRUITING
Fukui-shi
Research Site
RECRUITING
Fukuoka
Research Site
RECRUITING
Fukuoka
Research Site
RECRUITING
Gifu
Research Site
NOT_YET_RECRUITING
Iruma-gun
Research Site
RECRUITING
Ishinomaki
Research Site
RECRUITING
Kasuga-shi
Research Site
RECRUITING
Kitakyushu-shi
Research Site
RECRUITING
Kiyose-shi
Research Site
RECRUITING
Kiyose-shi
Research Site
RECRUITING
Kobe
Research Site
RECRUITING
Komatsu-shi
Research Site
RECRUITING
Kure-shi
Research Site
RECRUITING
Kyoto
Research Site
RECRUITING
Matsusaka-shi
Research Site
WITHDRAWN
Meguro-ku
Research Site
RECRUITING
Minatoku
Research Site
RECRUITING
Minatoku
Research Site
RECRUITING
Miyazaki
Research Site
RECRUITING
Mizunami-shi
Research Site
RECRUITING
Nagaoka-shi
Research Site
RECRUITING
Nagasaki
Research Site
RECRUITING
Nagoya
Research Site
RECRUITING
Nagoya
Research Site
NOT_YET_RECRUITING
Nagoya
Research Site
RECRUITING
Nerima-ku
Research Site
WITHDRAWN
Ohta-ku
Research Site
NOT_YET_RECRUITING
Okayama
Research Site
RECRUITING
Okayama
Research Site
NOT_YET_RECRUITING
Osaka
Research Site
RECRUITING
Sapporo
Research Site
NOT_YET_RECRUITING
Sendai
Research Site
RECRUITING
Sendai
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Shinjuku-ku
Research Site
RECRUITING
Shiogama
Research Site
RECRUITING
Takamatsu
Research Site
WITHDRAWN
Takatsuiki-shi
Research Site
RECRUITING
Tanabe-shi
Research Site
WITHDRAWN
Toshima-ku
Research Site
RECRUITING
Ube
Research Site
RECRUITING
Yokohama
Research Site
WITHDRAWN
Yokohama
Netherlands
Research Site
RECRUITING
Eindhoven
Research Site
NOT_YET_RECRUITING
Maastricht
Research Site
RECRUITING
Rotterdam
Research Site
RECRUITING
Rotterdam
Research Site
RECRUITING
Zutphen
New Zealand
Research Site
RECRUITING
Auckland
Research Site
RECRUITING
Auckland
Research Site
RECRUITING
Auckland
Research Site
RECRUITING
Hamilton West
Research Site
RECRUITING
Tauranga
Peru
Research Site
NOT_YET_RECRUITING
Cusco
Research Site
RECRUITING
Lima
Research Site
WITHDRAWN
Lima
Research Site
RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Lima
Research Site
NOT_YET_RECRUITING
Piura
Romania
Research Site
RECRUITING
Bucharest
Research Site
WITHDRAWN
Bucharest
Research Site
RECRUITING
Cluj-napoca
Research Site
RECRUITING
Cluj-napoca
Research Site
RECRUITING
Oradea
Research Site
RECRUITING
Timișoara
Research Site
RECRUITING
Timișoara
South Africa
Research Site
RECRUITING
Benoni
Research Site
RECRUITING
Cape Town
Research Site
RECRUITING
Durban
Research Site
RECRUITING
Durban
Research Site
RECRUITING
Emkhomazi
Research Site
RECRUITING
Kimberley
Research Site
RECRUITING
Somerset West
Research Site
RECRUITING
Tygervalley
Sweden
Research Site
RECRUITING
Gothenburg
Research Site
RECRUITING
Karlskrona
Research Site
RECRUITING
Lund
Research Site
RECRUITING
Örebro
Research Site
RECRUITING
Stockholm
Research Site
NOT_YET_RECRUITING
Stockholm
Thailand
Research Site
RECRUITING
Bang Kra So
Research Site
RECRUITING
Bangkok
Research Site
RECRUITING
Hat Yai
Research Site
RECRUITING
Muang
Research Site
RECRUITING
Muang
Research Site
RECRUITING
Mueang
Research Site
NOT_YET_RECRUITING
Rayong
Turkey
Research Site
RECRUITING
Adana
Research Site
RECRUITING
Ankara
Research Site
RECRUITING
Istanbul
Research Site
RECRUITING
Kayseri
Research Site
RECRUITING
Kocaeli
Research Site
RECRUITING
Mersin
Viet Nam
Research Site
RECRUITING
Da Nang
Research Site
RECRUITING
Haiphong
Research Site
RECRUITING
Hanoi
Research Site
NOT_YET_RECRUITING
Hanoi
Research Site
RECRUITING
Hồ Chí Minh
Research Site
RECRUITING
Ho Chi Minh City
Research Site
NOT_YET_RECRUITING
Ho Chi Minh City
Research Site
NOT_YET_RECRUITING
Ho Chi Minh City
Research Site
NOT_YET_RECRUITING
Huế
Contact Information
Primary
AstraZeneca Clinical Study Information Center
information.center@astrazeneca.com
1-877-240-9479
Time Frame
Start Date: 2025-03-25
Estimated Completion Date: 2029-06-05
Participants
Target number of participants: 990
Treatments
Experimental: Dose 1 of Tezepelumab
Tezepelumab, SC, Q4W
Experimental: Dose 2 of Tezepelumab
Tezepelumab, SC, Q4W
Placebo_comparator: Matching Placebo
Matching placebo, SC, Q4W
Sponsors
Leads: AstraZeneca
Collaborators: Amgen

This content was sourced from clinicaltrials.gov