Back to resultsLong-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations. (PROSPERO)
Primary Purpose
Chronic Obstructive Pulmonary Disease (COPD)
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Tozorakimab
Tozorakimab
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease (COPD) focused on measuring Chronic Obstructive Pulmonary Disease, COPD, Tozorakimab, MEDI3506, exacerbations, ICS, LABA/LAMA
Eligibility Criteria
Inclusion Criteria: Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies. Participants who received their last dose of IP in the predecessor studies within the previous 12 weeks and were not withdrawn from the predecessor study. FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1. Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies. Capable of giving signed informed consent. Exclusion Criteria: 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. Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor. Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies. Known history of: Severe allergic reaction to any monoclonal and polyclonal antibody. Allergy or reaction to any component of the IP formulation. 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. 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). Participants who are not able to comply with the study requirements, procedures, and restrictions.
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Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Placebo Comparator
Arm Label
Tozorakimab Dose 1
Tozorakimab Dose 2
Placebo
Arm Description
Injection subcutaneously Tozorakimab or placebo via pre-filled syringe.
Injection subcutaneously Tozorakimab via pre-filled syringe.
Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.
Outcomes
Primary Outcome Measures
Time to first severe COPD exacerbation in former smokers.
The primary efficacy endpoint is the time to first severe COPD exacerbation over the treatment period incorporating both the predecessor studies and PROSPERO. The primary endpoint will be assessed first in the Primary Population of former smokers, followed by the Overall Population of current and former smokers.
Secondary Outcome Measures
Time to first severe COPD exacerbation.
To be analysed as a key secondary endpoint in the Overall Population of current and former smokers.
Annualised rate of severe COPD exacerbations.
The annualised rate of severe COPD exacerbations over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population of current and former smokers.
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.
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.
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.
Trough serum concentrations of tozorakimab over the treatment period.
Pharmacokinetics: concentrations of Tozorakimab in trough serum.
Incidence of anti-drug antibodies.
Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05742802
Brief Title
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations.
Acronym
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 (MEDI3506) in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of Exacerbations.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2023 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
February 26, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease (COPD)
Keywords
Chronic Obstructive Pulmonary Disease, COPD, Tozorakimab, MEDI3506, exacerbations, ICS, LABA/LAMA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
2544 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tozorakimab Dose 1
Arm Type
Experimental
Arm Description
Injection subcutaneously Tozorakimab or placebo via pre-filled syringe.
Arm Title
Tozorakimab Dose 2
Arm Type
Experimental
Arm Description
Injection subcutaneously Tozorakimab via pre-filled syringe.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Injection subcutaneously with equivalent volume to Tozorakimab via pre-filled syringe.
Intervention Type
Combination Product
Intervention Name(s)
Tozorakimab
Intervention Description
Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and regimen in the PROSPERO study.
Intervention Type
Combination Product
Intervention Name(s)
Tozorakimab
Intervention Description
Participants previously randomised to Tozorakimab in one of the predecessor studies will be assigned to the same Tozorakimab dose and regimen in the PROSPERO study.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Participants previously randomised to placebo in one of the predecessor studies will be reassigned to one of the active doses of Tozorakimab or placebo in a 1:1:2 ratio.
Primary Outcome Measure Information:
Title
Time to first severe COPD exacerbation in former smokers.
Description
The primary efficacy endpoint is the time to first severe COPD exacerbation over the treatment period incorporating both the predecessor studies and PROSPERO. The primary endpoint will be assessed first in the Primary Population of former smokers, followed by the Overall Population of current and former smokers.
Time Frame
104 weeks total (52 weeks in this study)
Secondary Outcome Measure Information:
Title
Time to first severe COPD exacerbation.
Description
To be analysed as a key secondary endpoint in the Overall Population of current and former smokers.
Time Frame
104 weeks total (52 weeks in this study)
Title
Annualised rate of severe COPD exacerbations.
Description
The annualised rate of severe COPD exacerbations over the treatment period. Analyses will be conducted in the former smoker population, followed by the Overall Population of current and former smokers.
Time Frame
104 weeks total (52 weeks in this study)
Title
Time to first moderate-to-severe COPD exacerbation.
Description
To explore the extent to which treatment with each dose of Tozorakimab delays the time to first exacerbation compared with placebo.
Time Frame
104 weeks total (52 weeks in this study)
Title
Annualised rate of moderate to severe COPD exacerbations.
Description
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.
Time Frame
104 weeks total (52 weeks in this study)
Title
Time to all-cause death.
Description
To evaluate the effect of Tozorakimab as an add on to SoC compared with SoC plus placebo on time to all-cause death.
Time Frame
104 weeks total (52 weeks in this study)
Title
Trough serum concentrations of tozorakimab over the treatment period.
Description
Pharmacokinetics: concentrations of Tozorakimab in trough serum.
Time Frame
104 weeks total (52 weeks in this study)
Title
Incidence of anti-drug antibodies.
Description
Immunogenicity: presence of Tozorakimab anti-drug antibodies in blood serum.
Time Frame
104 weeks total (52 weeks in this study)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
130 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Participants who have completed the treatment period and have not been prematurely discontinued from IP in the predecessor studies.
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.
FOCBP (female(s) of childbearing potential) must have a negative urine pregnancy test at Visit 1.
Participants who are willing to continue using contraceptive methods as agreed to for the predecessor OBERON or TITANIA studies.
Capable of giving signed informed consent.
Exclusion Criteria:
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.
Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
Concurrent enrolment in other interventional clinical studies or treatment with another IP, with the exception of the OBERON and TITANIA predecessor studies.
Known history of:
Severe allergic reaction to any monoclonal and polyclonal antibody.
Allergy or reaction to any component of the IP formulation.
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.
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).
Participants who are not able to comply with the study requirements, procedures, and restrictions.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Sheffield
State/Province
Alabama
ZIP/Postal Code
35660
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85283
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lincoln
State/Province
California
ZIP/Postal Code
95648
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92663
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33435
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ormond Beach
State/Province
Florida
ZIP/Postal Code
32174
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Pensacola
State/Province
Florida
ZIP/Postal Code
32501
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Evergreen Park
State/Province
Illinois
ZIP/Postal Code
60805
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bowling Green
State/Province
Kentucky
ZIP/Postal Code
42101
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70836
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zachary
State/Province
Louisiana
ZIP/Postal Code
70791
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Farmington Hills
State/Province
Michigan
ZIP/Postal Code
48336
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Missoula
State/Province
Montana
ZIP/Postal Code
59808
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74133
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Rock Hill
State/Province
South Carolina
ZIP/Postal Code
29732
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Franklin
State/Province
Tennessee
ZIP/Postal Code
37067
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Amarillo
State/Province
Texas
ZIP/Postal Code
79106
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77022
Country
United States
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1121 ABE
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Buenos Aires
ZIP/Postal Code
C1414AIF
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Caba
ZIP/Postal Code
C1425BEN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Córdoba
ZIP/Postal Code
X5003DCE
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Florencio Varela
ZIP/Postal Code
1888
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
7600
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mar del Plata
ZIP/Postal Code
B7600GWV
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mendoza
ZIP/Postal Code
M5500GIP
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Quilmes
ZIP/Postal Code
B1878FNR
Country
Argentina
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
San Fernando
ZIP/Postal Code
B1646EBJ
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Miguel de Tucumán
ZIP/Postal Code
T4000IAR
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Research Site
City
Melbourne
ZIP/Postal Code
3000
Country
Australia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Spearwood
ZIP/Postal Code
6163
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wollongong
ZIP/Postal Code
2500
Country
Australia
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Namur
ZIP/Postal Code
5101
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Research Site
City
Blumenau
ZIP/Postal Code
89030-101
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Botucatu
ZIP/Postal Code
18618-686
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brasilia
ZIP/Postal Code
71681-603
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Curitiba
ZIP/Postal Code
80440-220
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
90035074
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
9061-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Porto Alegre
ZIP/Postal Code
91010-006
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rio de Janeiro
ZIP/Postal Code
22061-080
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sao Bernardo do Campo
ZIP/Postal Code
09750-420
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
01323-903
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
São Paulo
ZIP/Postal Code
01409-001
Country
Brazil
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dupnitsa
ZIP/Postal Code
2600
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kozloduy
ZIP/Postal Code
3320
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petrich
ZIP/Postal Code
2850
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ruse
ZIP/Postal Code
7002
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sliven
ZIP/Postal Code
8800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sofia
ZIP/Postal Code
1606
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sherwood Park
State/Province
Alberta
ZIP/Postal Code
T8L 0N2
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Quebec
ZIP/Postal Code
G1V 4G5
Country
Canada
Individual Site Status
Recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610000
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610014
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chengdu
ZIP/Postal Code
610083
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chongqing
ZIP/Postal Code
400037
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guangzhou
ZIP/Postal Code
510735
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haikou
ZIP/Postal Code
570311
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Nanchang
ZIP/Postal Code
330006
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taiyuan
ZIP/Postal Code
030001
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Wuxi
ZIP/Postal Code
214023
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Xiamen
ZIP/Postal Code
361004
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Xuzhou
ZIP/Postal Code
221009
Country
China
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yinchuan
ZIP/Postal Code
750004
Country
China
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Barranquilla
ZIP/Postal Code
80007
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ibague
ZIP/Postal Code
730006
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rionegro
ZIP/Postal Code
54040
Country
Colombia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brno
ZIP/Postal Code
625 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Broumov
ZIP/Postal Code
55001
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jihlava
ZIP/Postal Code
586 33
Country
Czechia
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Jindrichuv Hradec
ZIP/Postal Code
377 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Liberec 1
ZIP/Postal Code
460 63
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rokycany
ZIP/Postal Code
337 01
Country
Czechia
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hvidovre
ZIP/Postal Code
2650
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
København NV
ZIP/Postal Code
2400
Country
Denmark
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Næstved
ZIP/Postal Code
4700
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ålborg
ZIP/Postal Code
9000
Country
Denmark
Individual Site Status
Recruiting
Facility Name
Research Site
City
Helsinki
ZIP/Postal Code
00290
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hämeenlinna
ZIP/Postal Code
13530
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kuopio
ZIP/Postal Code
70210
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Turku
ZIP/Postal Code
20100
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Turku
ZIP/Postal Code
20520
Country
Finland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brest Cedex
ZIP/Postal Code
29609
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lyon Cedex 04
ZIP/Postal Code
69317
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
MARSEILLE cedex 15
ZIP/Postal Code
13326
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
10717
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Berlin
ZIP/Postal Code
12157
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Darmstadt
ZIP/Postal Code
64283
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Großhansdorf
ZIP/Postal Code
22927
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Halle
ZIP/Postal Code
06108
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Köln
ZIP/Postal Code
51069
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
München-Pasing
ZIP/Postal Code
81241
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
München
ZIP/Postal Code
80336
Country
Germany
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Peine
ZIP/Postal Code
31224
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Alexandroupolis
ZIP/Postal Code
68100
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Athens
ZIP/Postal Code
11527
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Exohi Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ioannina
ZIP/Postal Code
45500
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Patras
ZIP/Postal Code
26500
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Thessaloniki
ZIP/Postal Code
57010
Country
Greece
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Budapest
ZIP/Postal Code
1036
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Encs
ZIP/Postal Code
3860
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Mosonmagyaróvár
ZIP/Postal Code
9200
Country
Hungary
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Százhalombatta
ZIP/Postal Code
2440
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Research Site
City
Belagavi
ZIP/Postal Code
590010
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Coimbatore
ZIP/Postal Code
641028
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Dehradun
ZIP/Postal Code
248001
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Jaipur
ZIP/Postal Code
302039
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nagpur
ZIP/Postal Code
440012
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Nashik
ZIP/Postal Code
422007
Country
India
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ashkelon
ZIP/Postal Code
78278
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Beer Sheva
ZIP/Postal Code
8410101
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Carrara
ZIP/Postal Code
54033
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20142
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20157
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Statte
ZIP/Postal Code
74010
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Telese Terme
ZIP/Postal Code
82037
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tradate
ZIP/Postal Code
21049
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Vercelli
ZIP/Postal Code
13100
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Verona
ZIP/Postal Code
37124
Country
Italy
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chuo-ku
ZIP/Postal Code
103-0022
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Fukuoka-shi
ZIP/Postal Code
819-8555
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Iizuka-shi
ZIP/Postal Code
820-8505
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kawachinagano-shi
ZIP/Postal Code
586-8521
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kokubunji-shi
ZIP/Postal Code
185-0014
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Matsusaka-shi
ZIP/Postal Code
515-8544
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Okayama
ZIP/Postal Code
700-8558
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
531-0073
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Osaka-shi
ZIP/Postal Code
543-8555
Country
Japan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Toshima-ku
ZIP/Postal Code
170-0003
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Yokohama-shi
ZIP/Postal Code
223-0059
Country
Japan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Incheon
ZIP/Postal Code
21431
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Jeonju
ZIP/Postal Code
54907
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06591
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
07061
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
143-729
Country
Korea, Republic of
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Chihuahua
ZIP/Postal Code
31000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Del. Cuauhtemoc
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ecatepec de Morelos
ZIP/Postal Code
55450
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Guadalajara
ZIP/Postal Code
44200
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mexico
ZIP/Postal Code
01710
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Morelia
ZIP/Postal Code
58000
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mérida
ZIP/Postal Code
97070
Country
Mexico
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Oaxaca
ZIP/Postal Code
68020
Country
Mexico
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Groningen
ZIP/Postal Code
9713 GZ
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Harderwijk
ZIP/Postal Code
3844
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Heerlen
ZIP/Postal Code
6419 PC
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Zutphen
ZIP/Postal Code
7207 AE
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bodø
ZIP/Postal Code
8092
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Individual Site Status
Recruiting
Facility Name
Research Site
City
Oslo
ZIP/Postal Code
450
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Tønsberg
ZIP/Postal Code
3103
Country
Norway
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Godoy Cruz
ZIP/Postal Code
5501
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15046
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
15088
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L18
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
L27
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 21
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lima
ZIP/Postal Code
LIMA 31
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Piura
ZIP/Postal Code
20001
Country
Peru
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Baguio
ZIP/Postal Code
2600
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Cebu City
ZIP/Postal Code
6000
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Iloilo City
Country
Philippines
Individual Site Status
Recruiting
Facility Name
Research Site
City
Manila
ZIP/Postal Code
1000
Country
Philippines
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Białystok
ZIP/Postal Code
15-044
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Krakow
ZIP/Postal Code
30-033
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lublin
ZIP/Postal Code
20-412
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Ostróda
ZIP/Postal Code
14-100
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Poznań
ZIP/Postal Code
61-578
Country
Poland
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Rzeszów
ZIP/Postal Code
35-205
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wroclaw
ZIP/Postal Code
54-239
Country
Poland
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Wrocław
ZIP/Postal Code
53-301
Country
Poland
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lisboa
ZIP/Postal Code
1998-018
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Matosinhos
ZIP/Postal Code
4454-509
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Vila Nova de Gaia
ZIP/Postal Code
4434-502
Country
Portugal
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bucharest
ZIP/Postal Code
50159
Country
Romania
Individual Site Status
Withdrawn
Facility Name
Research Site
City
Cluj-Napoca
ZIP/Postal Code
400371
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Constanta
ZIP/Postal Code
900002
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Galdakao
ZIP/Postal Code
48960
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Mérida
ZIP/Postal Code
06800
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pozuelo de Alarcon
ZIP/Postal Code
28223
Country
Spain
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Santander
ZIP/Postal Code
39008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
413 46
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Göteborg
ZIP/Postal Code
41345
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Lund
ZIP/Postal Code
222 22
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Malmö
ZIP/Postal Code
205 02
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Stockholm
ZIP/Postal Code
11239
Country
Sweden
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Kaohsiung
ZIP/Postal Code
80756
Country
Taiwan
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Taichung
ZIP/Postal Code
40705
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bang Kra So
ZIP/Postal Code
11000
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bangkok
ZIP/Postal Code
10700
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hat Yai
ZIP/Postal Code
90110
Country
Thailand
Individual Site Status
Recruiting
Facility Name
Research Site
City
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Muang,
ZIP/Postal Code
55000
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Mueang
ZIP/Postal Code
20000
Country
Thailand
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Bradford
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Corby
ZIP/Postal Code
NN18 9EZ
Country
United Kingdom
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
100000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Hanoi
ZIP/Postal Code
10000
Country
Vietnam
Individual Site Status
Not yet recruiting
Facility Name
Research Site
City
Ho Chi Minh
ZIP/Postal Code
700000
Country
Vietnam
Individual Site Status
Not yet recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD Sharing Time Frame
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA Pharma Data Sharing Principles. For details of our timelines, please rerefer to our disclosure commitment at:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing Access Criteria
When a request has been approved AstraZeneca will provide access to the deidentified individual patient-level data in an approved sponsored tool . Signed Data Sharing Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information. Additionally, all users will need to accept the terms and conditions of the SAS MSE to gain access. For additional details, please review the Disclosure Statements at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD Sharing URL
https://astrazenecagroup-dt.pharmacm.com/DT/Home
Learn more about this trial
Long-term Efficacy and Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease With a History of Exacerbations.
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