Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations (PROSPERO).

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— PROSPERO  

Official title:

A Phase III, Multicentre, Randomised, Double-blind, Chronic-dosing, Parallel-group, Placebo-controlled Extension Study to Evaluate the Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations (PROSPERO).

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05742802
• Other study ID #: D9180C00008
• Secondary ID: 2022-501063-41-0
• Status: Recruiting
• Phase: Phase 3
• Start date: March 6, 2023
• Est. completion date: February 26, 2026

Study information

• Verified date: June 2024
• Source: AstraZeneca
• Contact: AstraZeneca Clinical Study Information Center
• Phone: 1-877-240-9479
• Email: information.center[@]astrazeneca.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Subjects who completed either OBERON or TITANIA will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo controlled, Parallel Group, Phase 3, extension study to evaluate the safety and efficacy of Tozorakimab in adult participants with symptomatic COPD.

Description:

Participants who have completed the study treatment period and have not been prematurely discontinued from IP in one of the predecessor studies, OBERON or TITANIA, will be offered the opportunity to consent for this Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel Group, Phase 3 extension study to evaluate the efficacy and safety of Tozorakimab versus placebo in adult (40 years and older) participants with symptomatic COPD and with a history of exacerbations

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1596
• Est. completion date: February 26, 2026
• Est. primary completion date: February 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 130 Years

Eligibility

Inclusion Criteria:

1. Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.

2. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study.

3. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.

4. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.

5. Capable of giving signed informed consent.

Exclusion Criteria:

1. Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment - which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise make the participation of the participant inappropriate.

2. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.

3. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.

4. Known history of:

1. Severe allergic reaction to any monoclonal and polyclonal antibody.

2. Allergy or reaction to any component of the IP formulation.

5. Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.

6. Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).

7. Participants who are not able to comply with the study requirements, procedures, and restrictions.

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Combination Product:
• Tozorakimab 1
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
• Tozorakimab 2
Participants randomised to either dose regimen in the predecessor studies will be assigned to a single Tozorakimab dose regimen in the PROSPERO study.
• Placebo
Participants previously randomised to placebo in one of the predecessor studies will be re-randomised in a 1:1 ratio to the active dose of Tozorakimab or placebo.

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Caba
Argentina	Research Site	Córdoba
Argentina	Research Site	Florencio Varela
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mar del Plata
Argentina	Research Site	Mendoza
Argentina	Research Site	Quilmes
Argentina	Research Site	San Fernando
Argentina	Research Site	San Miguel de Tucumán
Australia	Research Site	Frankstown
Australia	Research Site	Macquarie University
Australia	Research Site	Melbourne
Australia	Research Site	Spearwood
Australia	Research Site	Wollongong
Belgium	Research Site	Bruxelles
Belgium	Research Site	Gent
Belgium	Research Site	Leuven
Belgium	Research Site	Liege
Belgium	Research Site	Namur
Brazil	Research Site	Blumenau
Brazil	Research Site	Botucatu
Brazil	Research Site	Brasilia
Brazil	Research Site	Curitiba
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Porto Alegre
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Sao Bernardo do Campo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	Sao Paulo
Brazil	Research Site	São Paulo
Bulgaria	Research Site	Dupnitsa
Bulgaria	Research Site	Kozloduy
Bulgaria	Research Site	Lovech
Bulgaria	Research Site	Petrich
Bulgaria	Research Site	Ruse
Bulgaria	Research Site	Sliven
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Troyan
Bulgaria	Research Site	Vratsa
Canada	Research Site	Ajax	Ontario
Canada	Research Site	Edmonton	Alberta
Canada	Research Site	Quebec
Canada	Research Site	Sherwood Park	Alberta
Canada	Research Site	Winchester	Ontario
Chile	Research Site	Curico
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Santiago
Chile	Research Site	Talca
China	Research Site	Baotou
China	Research Site	Beijing
China	Research Site	Changchun
China	Research Site	Changde
China	Research Site	Changsha
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Chengdu
China	Research Site	Chongqing
China	Research Site	Chongqing
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Guangzhou
China	Research Site	Haikou
China	Research Site	Hangzhou
China	Research Site	Hohhot
China	Research Site	Kunming
China	Research Site	Linhai
China	Research Site	Nanchang
China	Research Site	Nanchang
China	Research Site	Nanjing
China	Research Site	Ningbo
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shanghai
China	Research Site	Shenyang
China	Research Site	Shenyang
China	Research Site	Shenzhen
China	Research Site	Shenzhen
China	Research Site	Shijiazhuang
China	Research Site	Suzhou
China	Research Site	Taiyuan
China	Research Site	Tianjin
China	Research Site	Wuhan
China	Research Site	Wuxi
China	Research Site	Xiamen
China	Research Site	Xuzhou
China	Research Site	Xuzhou
China	Research Site	Yangzhou
China	Research Site	Yinchuan
China	Research Site	Zhanjiang
China	Research Site	Zunyi
Colombia	Research Site	Barranquilla
Colombia	Research Site	Ibague
Colombia	Research Site	Rionegro
Colombia	Research Site	Zipaquira
Czechia	Research Site	Brno
Czechia	Research Site	Broumov
Czechia	Research Site	Jihlava
Czechia	Research Site	Jindrichuv Hradec
Czechia	Research Site	Liberec 1
Czechia	Research Site	Olomouc
Czechia	Research Site	Rokycany
Denmark	Research Site	Ålborg
Denmark	Research Site	Hvidovre
Denmark	Research Site	København NV
Denmark	Research Site	Naestved
Denmark	Research Site	Roskilde
Denmark	Research Site	Vejle
Finland	Research Site	Hämeenlinna
Finland	Research Site	Helsinki
Finland	Research Site	Kuopio
Finland	Research Site	Tampere
Finland	Research Site	Turku
France	Research Site	Bordeaux
France	Research Site	Brest Cedex
France	Research Site	Dijon Cedex
France	Research Site	La Tronche
France	Research Site	Limoges
France	Research Site	Lyon Cedex 04
France	Research Site	MARSEILLE cedex 15
France	Research Site	Montpellier Cedex 5
France	Research Site	Nantes
France	Research Site	Toulouse
Germany	Research Site	Bamberg
Germany	Research Site	Berlin
Germany	Research Site	Berlin
Germany	Research Site	Darmstadt
Germany	Research Site	Großhansdorf
Germany	Research Site	Halle
Germany	Research Site	Köln
Germany	Research Site	Marburg
Germany	Research Site	München
Germany	Research Site	München-Pasing
Germany	Research Site	Peine
Greece	Research Site	Alexandroupolis
Greece	Research Site	Athens
Greece	Research Site	Athens
Greece	Research Site	Exohi Thessaloniki
Greece	Research Site	Ioannina
Greece	Research Site	Patras
Greece	Research Site	Thessaloniki
Hungary	Research Site	Budapest
Hungary	Research Site	Encs
Hungary	Research Site	Gyöngyös
Hungary	Research Site	Mosonmagyaróvár
Hungary	Research Site	Százhalombatta
India	Research Site	Belagavi
India	Research Site	Coimbatore
India	Research Site	Dehradun
India	Research Site	Jaipur
India	Research Site	Nagpur
India	Research Site	Nashik
India	Research Site	New Delhi
India	Research Site	Thane
Israel	Research Site	Ashkelon
Israel	Research Site	Beer Sheva
Israel	Research Site	Jerusalem
Israel	Research Site	Kfar-Saba
Israel	Research Site	Rehovot
Israel	Research Site	Tel Aviv
Italy	Research Site	Bari
Italy	Research Site	Carrara
Italy	Research Site	Milano
Italy	Research Site	Milano
Italy	Research Site	Napoli
Italy	Research Site	Napoli
Italy	Research Site	Roma
Italy	Research Site	Salerno
Italy	Research Site	Sassari
Italy	Research Site	Statte
Italy	Research Site	Telese Terme
Italy	Research Site	Tradate
Italy	Research Site	Vercelli
Italy	Research Site	Verona
Japan	Research Site	Chuo-ku
Japan	Research Site	Fujieda-shi
Japan	Research Site	Fukuoka-shi
Japan	Research Site	Hamamatsu-shi
Japan	Research Site	Hiroshima-shi
Japan	Research Site	Iizuka-shi
Japan	Research Site	Itabashi-ku
Japan	Research Site	Joyo-shi
Japan	Research Site	Kawachinagano-shi
Japan	Research Site	Kobe-shi
Japan	Research Site	Kokubunji-shi
Japan	Research Site	Matsusaka-shi
Japan	Research Site	Mizunami-shi
Japan	Research Site	Nagoya-shi
Japan	Research Site	Obihiro
Japan	Research Site	Okayama
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Osaka-shi
Japan	Research Site	Sakai-shi
Japan	Research Site	Shizuoka-shi
Japan	Research Site	Toshima-ku
Japan	Research Site	Toyonaka-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Japan	Research Site	Yokohama-shi
Korea, Republic of	Research Site	Daegu
Korea, Republic of	Research Site	Incheon
Korea, Republic of	Research Site	Jeonju
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Korea, Republic of	Research Site	Seoul
Mexico	Research Site	Chihuahua
Mexico	Research Site	Del. Cuauhtemoc
Mexico	Research Site	Ecatepec de Morelos
Mexico	Research Site	Guadalajara
Mexico	Research Site	Guadalajara
Mexico	Research Site	Mérida
Mexico	Research Site	Mexico
Mexico	Research Site	Monterrey
Mexico	Research Site	Morelia
Mexico	Research Site	Oaxaca
Netherlands	Research Site	Groningen
Netherlands	Research Site	Harderwijk
Netherlands	Research Site	Heerlen
Netherlands	Research Site	Zutphen
Netherlands	Research Site	Zwolle
Norway	Research Site	Bergen
Norway	Research Site	Bodø
Norway	Research Site	Lørenskog
Norway	Research Site	Oslo
Norway	Research Site	Tønsberg
Peru	Research Site	Godoy Cruz
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Lima
Peru	Research Site	Piura
Philippines	Research Site	Baguio
Philippines	Research Site	Cebu City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Iloilo City
Philippines	Research Site	Manila
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Katowice
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Ostróda
Poland	Research Site	Ostrowiec Swietokrzyski
Poland	Research Site	Poznan
Poland	Research Site	Poznan
Poland	Research Site	Rzeszów
Poland	Research Site	Sosnowiec
Poland	Research Site	Wroclaw
Poland	Research Site	Wroclaw
Portugal	Research Site	Lisboa
Portugal	Research Site	Lisboa
Portugal	Research Site	Matosinhos
Portugal	Research Site	Vila Nova de Gaia
Romania	Research Site	Brasov
Romania	Research Site	Bucharest
Romania	Research Site	Cluj-Napoca
Romania	Research Site	Constanta
Romania	Research Site	Timisoara
Spain	Research Site	Galdakao
Spain	Research Site	Madrid
Spain	Research Site	Málaga
Spain	Research Site	Merida
Spain	Research Site	Pozuelo de Alarcon
Spain	Research Site	Santander
Spain	Research Site	Valencia
Spain	Research Site	Zaragoza
Sweden	Research Site	Göteborg
Sweden	Research Site	Göteborg
Sweden	Research Site	Lund
Sweden	Research Site	Malmö
Sweden	Research Site	Stockholm
Taiwan	Research Site	Hsinchu
Taiwan	Research Site	Kaohsiung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taichung
Taiwan	Research Site	Taoyuan
Taiwan	Research Site	Yunlin
Thailand	Research Site	Bang Kra So
Thailand	Research Site	Bangkok
Thailand	Research Site	Hat Yai
Thailand	Research Site	Khon Kaen
Thailand	Research Site	Muang
Thailand	Research Site	Muang,
Thailand	Research Site	Mueang
Thailand	Research Site	Nakhon Ratchasima
Turkey	Research Site	Ankara
Turkey	Research Site	Istanbul
Turkey	Research Site	Mersin
United Kingdom	Research Site	Bradford
United Kingdom	Research Site	Corby
United Kingdom	Research Site	Corby
United Kingdom	Research Site	Enfield
United Kingdom	Research Site	High Wycombe
United Kingdom	Research Site	Northwood
United Kingdom	Research Site	Preston
United Kingdom	Research Site	Shipley
United States	Research Site	Amarillo	Texas
United States	Research Site	Amarillo	Texas
United States	Research Site	Bakersfield	California
United States	Research Site	Baltimore	Maryland
United States	Research Site	Baton Rouge	Louisiana
United States	Research Site	Bowling Green	Kentucky
United States	Research Site	Boynton Beach	Florida
United States	Research Site	Cape Coral	Florida
United States	Research Site	Colchester	Vermont
United States	Research Site	DuBois	Pennsylvania
United States	Research Site	Durham	North Carolina
United States	Research Site	Evergreen Park	Illinois
United States	Research Site	Farmington Hills	Michigan
United States	Research Site	Fort Worth	Texas
United States	Research Site	Franklin	Tennessee
United States	Research Site	Gastonia	North Carolina
United States	Research Site	Greenwood	Indiana
United States	Research Site	Houston	Texas
United States	Research Site	Huntsville	Alabama
United States	Research Site	Iowa City	Iowa
United States	Research Site	Kansas City	Kansas
United States	Research Site	Lincoln	California
United States	Research Site	McKinney	Texas
United States	Research Site	Missoula	Montana
United States	Research Site	Newport Beach	California
United States	Research Site	Normal	Illinois
United States	Research Site	North Dartmouth	Massachusetts
United States	Research Site	Northridge	California
United States	Research Site	Ormond Beach	Florida
United States	Research Site	Pensacola	Florida
United States	Research Site	Philadelphia	Pennsylvania
United States	Research Site	Plantation	Florida
United States	Research Site	Rochester	Minnesota
United States	Research Site	Rock Hill	South Carolina
United States	Research Site	Saint Louis	Missouri
United States	Research Site	Sheffield	Alabama
United States	Research Site	Tampa	Florida
United States	Research Site	Tampa	Florida
United States	Research Site	Tempe	Arizona
United States	Research Site	Tulsa	Oklahoma
United States	Research Site	Webster	Texas
United States	Research Site	White Marsh	Maryland
United States	Research Site	Williamsburg	Virginia
United States	Research Site	Zachary	Louisiana
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Hanoi
Vietnam	Research Site	Ho Chi Minh
Vietnam	Research Site	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

United States,  Vietnam,  Argentina,  Australia,  Belgium,  Brazil,  Bulgaria,  Canada,  Chile,  China,  Colombia,  Czechia,  Denmark,  Finland,  France,  Germany,  Greece,  Hungary,  India,  Israel,  Italy,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Norway,  Peru,  Philippines,  Poland,  Portugal,  Romania,  Spain,  Sweden,  Taiwan,  Thailand,  Turkey,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annualised rate of severe COPD exacerbations in former smokers.	The primary efficacy endpoint is the rate of severe COPD exacerbations.	Up to 104 weeks.
Secondary	The annualised rate of severe COPD exacerbations	To be analyzed as a key secondary endpoint in the Overall Population in former or current smokers.	Up to 104 weeks.
Secondary	Time to First Severe COPD Exacerbations	Time to first severe COPD exacerbation over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population in former or current smokers.	Up to 104 weeks.
Secondary	Time to first moderate-to-severe COPD exacerbation.	To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.	Up to 104 weeks.
Secondary	Annualised rate of moderate to severe COPD exacerbations.	To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on the rate of moderate to severe COPD exacerbations.	Up to 104 weeks.
Secondary	Time to all-cause death.	To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.	Up to 104 weeks.
Secondary	Trough serum concentrations of tozorakimab over the treatment period.	Pharmacokinetics: concentrations of Tozorakimab in trough serum.	Up to 104 weeks.
Secondary	Incidence of anti-drug antibodies.	Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.	Up to 104 weeks.