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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05878769




Registration number
NCT05878769
Ethics application status
Date submitted
19/05/2023
Date registered
26/05/2023
Date last updated
7/06/2024

Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
GB43374
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Astegolimab

Experimental: Open-Label Extension - Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study


Treatment: Drugs: Astegolimab
Participants will receive SC astegolimab Q2W
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Incidence of all adverse events (AEs)
Timepoint [1] 0 0
Up to 12 weeks after last dose of study treatment

Eligibility
Key inclusion criteria
- Completion of the 52-week treatment period in either parent GB43311 or GB44332
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Withdrawal of consent and/or premature discontinuation from parent study

- Any permanent discontinuation of study drug in parent study

- Significant non-compliance in the parent study, specifically defined as missing
scheduled visits, per investigator's judgment

- Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines
or other accepted guidelines since enrolling in the parent study

- Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary
fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension,
alpha-1-antitrypsin deficiency) since enrolling in the parent study

- Any new unstable cardiac disease, myocardial infarction, or New York Heart Association
Class III or IV heart failure since enrolling in the parent study

Study design
Purpose of the study
Treatment
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
28/06/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
30/06/2027
Actual
Sample size
Target
2000
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
Recruitment hospital [1] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [2] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [3] 0 0
TrialsWest Pty Ltd - Spearwood
Recruitment postcode(s) [1] 0 0
5042 - Bedford Park
Recruitment postcode(s) [2] 0 0
3128 - Box Hill
Recruitment postcode(s) [3] 0 0
6163 - Spearwood
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Florida
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United States of America
State/province [4] 0 0
Massachusetts
Country [5] 0 0
United States of America
State/province [5] 0 0
Michigan
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United States of America
State/province [6] 0 0
Missouri
Country [7] 0 0
United States of America
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Nevada
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United States of America
State/province [8] 0 0
North Carolina
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United States of America
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Oklahoma
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United States of America
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Pennsylvania
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United States of America
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South Carolina
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United States of America
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Texas
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Argentina
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Buenos Aires
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Argentina
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Caba
Country [15] 0 0
Argentina
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Ciudad Autonoma Buenos Aires
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Argentina
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Córdoba
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Argentina
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Lobos
Country [18] 0 0
Argentina
State/province [18] 0 0
Mar Del Plata
Country [19] 0 0
Argentina
State/province [19] 0 0
Mendoza, Mendoza City
Country [20] 0 0
Argentina
State/province [20] 0 0
Mendoza
Country [21] 0 0
Argentina
State/province [21] 0 0
Quilmes
Country [22] 0 0
Argentina
State/province [22] 0 0
Rosario
Country [23] 0 0
Argentina
State/province [23] 0 0
San Fernando
Country [24] 0 0
Argentina
State/province [24] 0 0
San Miguel de Tucuman
Country [25] 0 0
Argentina
State/province [25] 0 0
San Miguel de Tucumán
Country [26] 0 0
Argentina
State/province [26] 0 0
Villa Vatteone
Country [27] 0 0
Belgium
State/province [27] 0 0
Edegem
Country [28] 0 0
Belgium
State/province [28] 0 0
Erpent
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Belgium
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Leuven
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Belgium
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Mechelen
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Belgium
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Roeselare
Country [32] 0 0
Belgium
State/province [32] 0 0
Thuin
Country [33] 0 0
Belgium
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Yoir
Country [34] 0 0
Bulgaria
State/province [34] 0 0
Dupnitsa
Country [35] 0 0
Bulgaria
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Haskovo
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Bulgaria
State/province [36] 0 0
Lovech
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Bulgaria
State/province [37] 0 0
Montana
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Bulgaria
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Pernik
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Bulgaria
State/province [39] 0 0
Pleven
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Bulgaria
State/province [40] 0 0
Plovdiv
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Bulgaria
State/province [41] 0 0
Sofia
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Bulgaria
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Stara Zagora
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Vratsa
Country [44] 0 0
Canada
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Ontario
Country [45] 0 0
Canada
State/province [45] 0 0
Quebec
Country [46] 0 0
Chile
State/province [46] 0 0
Providencia
Country [47] 0 0
Chile
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Recoleta
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Chile
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Santiago
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Chile
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Valparaiso
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Czechia
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Jind?ich?v Hradec
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Czechia
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Kralupy nad Vltavou
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Czechia
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Tabor
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Denmark
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Aalborg
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Denmark
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Hellerup
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Denmark
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Hvidovre
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France
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Lyon
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France
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Marseille
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France
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Nice
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Germany
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Augsburg
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Germany
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Bamberg
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Germany
State/province [61] 0 0
Berlin
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Germany
State/province [62] 0 0
Deggingen
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Germany
State/province [63] 0 0
Essen
Country [64] 0 0
Germany
State/province [64] 0 0
Frankfurt am Main
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Germany
State/province [65] 0 0
Koblenz
Country [66] 0 0
Germany
State/province [66] 0 0
Landsberg
Country [67] 0 0
Germany
State/province [67] 0 0
Leipzig
Country [68] 0 0
Germany
State/province [68] 0 0
Mainz
Country [69] 0 0
Germany
State/province [69] 0 0
Marburg
Country [70] 0 0
Germany
State/province [70] 0 0
Peine
Country [71] 0 0
Israel
State/province [71] 0 0
Ashkelon
Country [72] 0 0
Israel
State/province [72] 0 0
Jerusalem
Country [73] 0 0
Israel
State/province [73] 0 0
Petach Tiqwa
Country [74] 0 0
Israel
State/province [74] 0 0
Ramat Gan
Country [75] 0 0
Israel
State/province [75] 0 0
Rehovot
Country [76] 0 0
Israel
State/province [76] 0 0
Tel Aviv-Yafo
Country [77] 0 0
Korea, Republic of
State/province [77] 0 0
Incheon
Country [78] 0 0
Korea, Republic of
State/province [78] 0 0
Jeollabuk-do
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Korea, Republic of
State/province [79] 0 0
Seoul
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Mexico
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Durango
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Mexico
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Jalisco
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Mexico
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Nuevo LEON
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Netherlands
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Breda
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Netherlands
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Eindhoven
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Netherlands
State/province [85] 0 0
Hoorn
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New Zealand
State/province [86] 0 0
Auckland
Country [87] 0 0
New Zealand
State/province [87] 0 0
Christchurch
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Poland
State/province [88] 0 0
Bydgoszcz
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Poland
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Kielce
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Poland
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Krakow
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Poland
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Kraków
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Poland
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Lublin
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Poland
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Lódz
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Poland
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Nowa Sól
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Poland
State/province [95] 0 0
Ostrowiec Swietokrzysk
Country [96] 0 0
Poland
State/province [96] 0 0
Poznan
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Poland
State/province [97] 0 0
Rzeszów
Country [98] 0 0
Poland
State/province [98] 0 0
Siedlce
Country [99] 0 0
Poland
State/province [99] 0 0
Sosnowiec
Country [100] 0 0
Poland
State/province [100] 0 0
Warszawa
Country [101] 0 0
Poland
State/province [101] 0 0
Wroclaw
Country [102] 0 0
Romania
State/province [102] 0 0
Brasov
Country [103] 0 0
Romania
State/province [103] 0 0
Bucharest
Country [104] 0 0
Romania
State/province [104] 0 0
Cluj-Napoca
Country [105] 0 0
Romania
State/province [105] 0 0
Suceava
Country [106] 0 0
South Africa
State/province [106] 0 0
Cape Town
Country [107] 0 0
South Africa
State/province [107] 0 0
City Of Tshwane
Country [108] 0 0
South Africa
State/province [108] 0 0
Ekurhuleni
Country [109] 0 0
South Africa
State/province [109] 0 0
Kraaifontein
Country [110] 0 0
Spain
State/province [110] 0 0
Badajoz
Country [111] 0 0
Spain
State/province [111] 0 0
Cantabria
Country [112] 0 0
Spain
State/province [112] 0 0
LA Coruña
Country [113] 0 0
Spain
State/province [113] 0 0
Caceres
Country [114] 0 0
Spain
State/province [114] 0 0
Madrid
Country [115] 0 0
Spain
State/province [115] 0 0
Malaga
Country [116] 0 0
Sweden
State/province [116] 0 0
Lidingö
Country [117] 0 0
Sweden
State/province [117] 0 0
Malmö
Country [118] 0 0
Sweden
State/province [118] 0 0
Stockholm
Country [119] 0 0
United Kingdom
State/province [119] 0 0
Bradford
Country [120] 0 0
United Kingdom
State/province [120] 0 0
Leicester

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Hoffmann-La Roche
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to assess the long-term safety and to explore the efficacy of
astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have
completed the 52-week placebo-controlled treatment period in parent studies GB43311 or
GB44332.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05878769
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Clinical Trials
Address 0 0
Hoffmann-La Roche
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Reference Study ID Number: GB43374 https://forpatients.roche.com/
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05878769