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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05878769
Registration number
NCT05878769
Ethics application status
Date submitted
19/05/2023
Date registered
26/05/2023
Date last updated
8/07/2025
Titles & IDs
Public title
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
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Scientific title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
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Secondary ID [1]
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GB43374
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease
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Condition category
Condition code
Respiratory
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Chronic obstructive pulmonary disease
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Incidence of all adverse events (AEs)
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Assessment method [1]
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Timepoint [1]
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Up to 12 weeks after last dose of study treatment
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Eligibility
Key inclusion criteria
* Completion of the 52-week treatment period in either parent GB43311 or GB44332
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Minimum age
40
Years
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Maximum age
90
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Not applicable
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
28/06/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
30/06/2027
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Actual
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Sample size
Target
2000
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC,WA
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Recruitment hospital [1]
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Flinders Medical Centre - Bedford Park
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Recruitment hospital [2]
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Box Hill Hospital - Box Hill
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Recruitment hospital [3]
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Institute for Respiratory Health Inc - Midland
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Recruitment hospital [4]
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TrialsWest Pty Ltd - Spearwood
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Recruitment postcode(s) [1]
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5042 - Bedford Park
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Recruitment postcode(s) [2]
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3128 - Box Hill
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Recruitment postcode(s) [3]
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6056 - Midland
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Recruitment postcode(s) [4]
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6163 - Spearwood
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Recruitment outside Australia
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State/province [148]
0
0
Augsburg
Query!
Country [149]
0
0
Germany
Query!
State/province [149]
0
0
Bamberg
Query!
Country [150]
0
0
Germany
Query!
State/province [150]
0
0
Bendorf
Query!
Country [151]
0
0
Germany
Query!
State/province [151]
0
0
Berlin
Query!
Country [152]
0
0
Germany
Query!
State/province [152]
0
0
Darmstadt
Query!
Country [153]
0
0
Germany
Query!
State/province [153]
0
0
Deggingen
Query!
Country [154]
0
0
Germany
Query!
State/province [154]
0
0
Essen
Query!
Country [155]
0
0
Germany
Query!
State/province [155]
0
0
Frankfurt am Main
Query!
Country [156]
0
0
Germany
Query!
State/province [156]
0
0
Frankfurt
Query!
Country [157]
0
0
Germany
Query!
State/province [157]
0
0
Hamburg
Query!
Country [158]
0
0
Germany
Query!
State/province [158]
0
0
Hannover
Query!
Country [159]
0
0
Germany
Query!
State/province [159]
0
0
Heidelberg
Query!
Country [160]
0
0
Germany
Query!
State/province [160]
0
0
Immenhausen
Query!
Country [161]
0
0
Germany
Query!
State/province [161]
0
0
Landsberg
Query!
Country [162]
0
0
Germany
Query!
State/province [162]
0
0
Leipzig
Query!
Country [163]
0
0
Germany
Query!
State/province [163]
0
0
Lübeck
Query!
Country [164]
0
0
Germany
Query!
State/province [164]
0
0
Magdeburg
Query!
Country [165]
0
0
Germany
Query!
State/province [165]
0
0
Mainz
Query!
Country [166]
0
0
Germany
Query!
State/province [166]
0
0
Marburg
Query!
Country [167]
0
0
Germany
Query!
State/province [167]
0
0
München
Query!
Country [168]
0
0
Germany
Query!
State/province [168]
0
0
Neu-Isenburg
Query!
Country [169]
0
0
Germany
Query!
State/province [169]
0
0
Peine
Query!
Country [170]
0
0
Germany
Query!
State/province [170]
0
0
Rheine
Query!
Country [171]
0
0
Germany
Query!
State/province [171]
0
0
Rosenheim
Query!
Country [172]
0
0
Greece
Query!
State/province [172]
0
0
Athens
Query!
Country [173]
0
0
Greece
Query!
State/province [173]
0
0
Athina
Query!
Country [174]
0
0
Greece
Query!
State/province [174]
0
0
Herakleion
Query!
Country [175]
0
0
Greece
Query!
State/province [175]
0
0
Ioannina
Query!
Country [176]
0
0
Greece
Query!
State/province [176]
0
0
Thessaloniki
Query!
Country [177]
0
0
Hong Kong
Query!
State/province [177]
0
0
Hong Kong
Query!
Country [178]
0
0
Hungary
Query!
State/province [178]
0
0
Budapest
Query!
Country [179]
0
0
India
Query!
State/province [179]
0
0
Andhra Pradesh
Query!
Country [180]
0
0
India
Query!
State/province [180]
0
0
Haryana
Query!
Country [181]
0
0
India
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State/province [181]
0
0
Karnataka
Query!
Country [182]
0
0
India
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State/province [182]
0
0
Maharashtra
Query!
Country [183]
0
0
India
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State/province [183]
0
0
Rajasthan
Query!
Country [184]
0
0
India
Query!
State/province [184]
0
0
Uttar Pradesh
Query!
Country [185]
0
0
Israel
Query!
State/province [185]
0
0
Ashdod
Query!
Country [186]
0
0
Israel
Query!
State/province [186]
0
0
Ashkelon
Query!
Country [187]
0
0
Israel
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State/province [187]
0
0
Be'er Ya'akov
Query!
Country [188]
0
0
Israel
Query!
State/province [188]
0
0
Beer Sheva
Query!
Country [189]
0
0
Israel
Query!
State/province [189]
0
0
Haifa
Query!
Country [190]
0
0
Israel
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State/province [190]
0
0
Jerusalem
Query!
Country [191]
0
0
Israel
Query!
State/province [191]
0
0
Kfar- Saba
Query!
Country [192]
0
0
Israel
Query!
State/province [192]
0
0
Petach Tiqwa
Query!
Country [193]
0
0
Israel
Query!
State/province [193]
0
0
Ramat Gan
Query!
Country [194]
0
0
Israel
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State/province [194]
0
0
Rehovot
Query!
Country [195]
0
0
Israel
Query!
State/province [195]
0
0
Tel Aviv-Yafo
Query!
Country [196]
0
0
Italy
Query!
State/province [196]
0
0
Campania
Query!
Country [197]
0
0
Italy
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State/province [197]
0
0
Emilia-Romagna
Query!
Country [198]
0
0
Italy
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State/province [198]
0
0
Lombardia
Query!
Country [199]
0
0
Italy
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State/province [199]
0
0
Sicilia
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Country [200]
0
0
Japan
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State/province [200]
0
0
Fukuoka-Shi Nishi-Ku
Query!
Country [201]
0
0
Japan
Query!
State/province [201]
0
0
Kishiwada-Shi
Query!
Country [202]
0
0
Japan
Query!
State/province [202]
0
0
Koto
Query!
Country [203]
0
0
Japan
Query!
State/province [203]
0
0
Okayama-Shi Minami-ku
Query!
Country [204]
0
0
Japan
Query!
State/province [204]
0
0
Sapporo-shi Chuo-ku
Query!
Country [205]
0
0
Japan
Query!
State/province [205]
0
0
Takamatsu
Query!
Country [206]
0
0
Japan
Query!
State/province [206]
0
0
Yokohama shi
Query!
Country [207]
0
0
Kenya
Query!
State/province [207]
0
0
Kilifi
Query!
Country [208]
0
0
Kenya
Query!
State/province [208]
0
0
Machakos
Query!
Country [209]
0
0
Kenya
Query!
State/province [209]
0
0
Nairobi
Query!
Country [210]
0
0
Kenya
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State/province [210]
0
0
Thika
Query!
Country [211]
0
0
Korea, Republic of
Query!
State/province [211]
0
0
Bucheon-si,
Query!
Country [212]
0
0
Korea, Republic of
Query!
State/province [212]
0
0
Daegu
Query!
Country [213]
0
0
Korea, Republic of
Query!
State/province [213]
0
0
Gyeonggi-do
Query!
Country [214]
0
0
Korea, Republic of
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State/province [214]
0
0
Incheon
Query!
Country [215]
0
0
Korea, Republic of
Query!
State/province [215]
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0
Jeollabuk-do
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Country [216]
0
0
Korea, Republic of
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State/province [216]
0
0
Seoul
Query!
Country [217]
0
0
Korea, Republic of
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State/province [217]
0
0
Wonju-Si
Query!
Country [218]
0
0
Latvia
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State/province [218]
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0
Daugavpils
Query!
Country [219]
0
0
Latvia
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State/province [219]
0
0
R?ga
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Country [220]
0
0
Latvia
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State/province [220]
0
0
Riga
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Country [221]
0
0
Mexico
Query!
State/province [221]
0
0
Jalisco
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Country [222]
0
0
Mexico
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State/province [222]
0
0
Guadalajara
Query!
Country [223]
0
0
Mexico
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State/province [223]
0
0
Monterrey
Query!
Country [224]
0
0
Netherlands
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State/province [224]
0
0
Amersfoort
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Country [225]
0
0
Netherlands
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State/province [225]
0
0
Breda
Query!
Country [226]
0
0
Netherlands
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State/province [226]
0
0
Eindhoven
Query!
Country [227]
0
0
Netherlands
Query!
State/province [227]
0
0
Hoorn
Query!
Country [228]
0
0
Netherlands
Query!
State/province [228]
0
0
Zwolle
Query!
Country [229]
0
0
New Zealand
Query!
State/province [229]
0
0
Auckland
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Country [230]
0
0
New Zealand
Query!
State/province [230]
0
0
Christchurch
Query!
Country [231]
0
0
New Zealand
Query!
State/province [231]
0
0
Dunedin
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Country [232]
0
0
New Zealand
Query!
State/province [232]
0
0
Hamilton
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Country [233]
0
0
New Zealand
Query!
State/province [233]
0
0
Paraparaumu
Query!
Country [234]
0
0
Peru
Query!
State/province [234]
0
0
Lima
Query!
Country [235]
0
0
Peru
Query!
State/province [235]
0
0
San Isidro
Query!
Country [236]
0
0
Philippines
Query!
State/province [236]
0
0
Caloocan City
Query!
Country [237]
0
0
Philippines
Query!
State/province [237]
0
0
Dasmarinas
Query!
Country [238]
0
0
Philippines
Query!
State/province [238]
0
0
Iloilo City
Query!
Country [239]
0
0
Philippines
Query!
State/province [239]
0
0
Lipa City
Query!
Country [240]
0
0
Philippines
Query!
State/province [240]
0
0
Quezon City
Query!
Country [241]
0
0
Poland
Query!
State/province [241]
0
0
Dolnoslaskie
Query!
Country [242]
0
0
Poland
Query!
State/province [242]
0
0
Lódzkie
Query!
Country [243]
0
0
Poland
Query!
State/province [243]
0
0
Bia?ystok
Query!
Country [244]
0
0
Poland
Query!
State/province [244]
0
0
Bydgoszcz
Query!
Country [245]
0
0
Poland
Query!
State/province [245]
0
0
Chojnice
Query!
Country [246]
0
0
Poland
Query!
State/province [246]
0
0
Gdynia
Query!
Country [247]
0
0
Poland
Query!
State/province [247]
0
0
Grudzadz
Query!
Country [248]
0
0
Poland
Query!
State/province [248]
0
0
Katowice
Query!
Country [249]
0
0
Poland
Query!
State/province [249]
0
0
Kielce
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Country [250]
0
0
Poland
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State/province [250]
0
0
Krakow
Query!
Country [251]
0
0
Poland
Query!
State/province [251]
0
0
Kraków
Query!
Country [252]
0
0
Poland
Query!
State/province [252]
0
0
Ksawerow
Query!
Country [253]
0
0
Poland
Query!
State/province [253]
0
0
Lodz
Query!
Country [254]
0
0
Poland
Query!
State/province [254]
0
0
Lublin
Query!
Country [255]
0
0
Poland
Query!
State/province [255]
0
0
Nowa Sól
Query!
Country [256]
0
0
Poland
Query!
State/province [256]
0
0
Ostrowiec Swietokrzysk
Query!
Country [257]
0
0
Poland
Query!
State/province [257]
0
0
Poznan
Query!
Country [258]
0
0
Poland
Query!
State/province [258]
0
0
Radom
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Country [259]
0
0
Poland
Query!
State/province [259]
0
0
Rzeszów
Query!
Country [260]
0
0
Poland
Query!
State/province [260]
0
0
Siedlce
Query!
Country [261]
0
0
Poland
Query!
State/province [261]
0
0
Sopot
Query!
Country [262]
0
0
Poland
Query!
State/province [262]
0
0
Sosnowiec
Query!
Country [263]
0
0
Poland
Query!
State/province [263]
0
0
Szczecin
Query!
Country [264]
0
0
Poland
Query!
State/province [264]
0
0
Tarnow
Query!
Country [265]
0
0
Poland
Query!
State/province [265]
0
0
Trzebnica
Query!
Country [266]
0
0
Poland
Query!
State/province [266]
0
0
Warszawa
Query!
Country [267]
0
0
Poland
Query!
State/province [267]
0
0
Wroc?aw
Query!
Country [268]
0
0
Poland
Query!
State/province [268]
0
0
Wroclaw
Query!
Country [269]
0
0
Puerto Rico
Query!
State/province [269]
0
0
Guaynabo
Query!
Country [270]
0
0
Romania
Query!
State/province [270]
0
0
Brasov
Query!
Country [271]
0
0
Romania
Query!
State/province [271]
0
0
Bucharest
Query!
Country [272]
0
0
Romania
Query!
State/province [272]
0
0
Cluj-Napoca
Query!
Country [273]
0
0
Romania
Query!
State/province [273]
0
0
Suceava
Query!
Country [274]
0
0
South Africa
Query!
State/province [274]
0
0
Gauteng
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Country [275]
0
0
South Africa
Query!
State/province [275]
0
0
Bloemfontein
Query!
Country [276]
0
0
South Africa
Query!
State/province [276]
0
0
Cape Town
Query!
Country [277]
0
0
South Africa
Query!
State/province [277]
0
0
City Of Cape Town
Query!
Country [278]
0
0
South Africa
Query!
State/province [278]
0
0
City Of Johannesburg
Query!
Country [279]
0
0
South Africa
Query!
State/province [279]
0
0
City Of Tshwane
Query!
Country [280]
0
0
South Africa
Query!
State/province [280]
0
0
Ekurhuleni
Query!
Country [281]
0
0
South Africa
Query!
State/province [281]
0
0
Ethekwini
Query!
Country [282]
0
0
South Africa
Query!
State/province [282]
0
0
Kraaifontein
Query!
Country [283]
0
0
South Africa
Query!
State/province [283]
0
0
Pretoria
Query!
Country [284]
0
0
South Africa
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State/province [284]
0
0
Somerset West
Query!
Country [285]
0
0
South Africa
Query!
State/province [285]
0
0
Welkom
Query!
Country [286]
0
0
Spain
Query!
State/province [286]
0
0
Badajoz
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Country [287]
0
0
Spain
Query!
State/province [287]
0
0
Cantabria
Query!
Country [288]
0
0
Spain
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State/province [288]
0
0
Islas Baleares
Query!
Country [289]
0
0
Spain
Query!
State/province [289]
0
0
LA Coruna
Query!
Country [290]
0
0
Spain
Query!
State/province [290]
0
0
Madrid
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Country [291]
0
0
Spain
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State/province [291]
0
0
Malaga
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Country [292]
0
0
Spain
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State/province [292]
0
0
Valencia
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Country [293]
0
0
Spain
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State/province [293]
0
0
Barcelona
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Country [294]
0
0
Spain
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State/province [294]
0
0
Granada
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Country [295]
0
0
Spain
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State/province [295]
0
0
Sevilla
Query!
Country [296]
0
0
Sweden
Query!
State/province [296]
0
0
Lidingö
Query!
Country [297]
0
0
Sweden
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State/province [297]
0
0
Linkoping
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Country [298]
0
0
Sweden
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State/province [298]
0
0
Malmö
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Country [299]
0
0
Sweden
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State/province [299]
0
0
Stockholm
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Country [300]
0
0
Switzerland
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State/province [300]
0
0
Zurich
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Country [301]
0
0
Taiwan
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State/province [301]
0
0
Chang Hua
Query!
Country [302]
0
0
Taiwan
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State/province [302]
0
0
Kaoshiung City
Query!
Country [303]
0
0
Taiwan
Query!
State/province [303]
0
0
New Taipei
Query!
Country [304]
0
0
Taiwan
Query!
State/province [304]
0
0
Taipei City
Query!
Country [305]
0
0
Taiwan
Query!
State/province [305]
0
0
Taipei
Query!
Country [306]
0
0
Thailand
Query!
State/province [306]
0
0
Khon Kaen
Query!
Country [307]
0
0
Thailand
Query!
State/province [307]
0
0
Muang
Query!
Country [308]
0
0
Turkey
Query!
State/province [308]
0
0
Adana
Query!
Country [309]
0
0
Turkey
Query!
State/province [309]
0
0
Kirikkale
Query!
Country [310]
0
0
Turkey
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State/province [310]
0
0
Rize Merkez
Query!
Country [311]
0
0
United Kingdom
Query!
State/province [311]
0
0
Middlesex
Query!
Country [312]
0
0
United Kingdom
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State/province [312]
0
0
Bellshill
Query!
Country [313]
0
0
United Kingdom
Query!
State/province [313]
0
0
Bradford
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Country [314]
0
0
United Kingdom
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State/province [314]
0
0
Cambridge
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Country [315]
0
0
United Kingdom
Query!
State/province [315]
0
0
Cardiff
Query!
Country [316]
0
0
United Kingdom
Query!
State/province [316]
0
0
Chesterfield
Query!
Country [317]
0
0
United Kingdom
Query!
State/province [317]
0
0
Chorley
Query!
Country [318]
0
0
United Kingdom
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State/province [318]
0
0
Cottingham
Query!
Country [319]
0
0
United Kingdom
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State/province [319]
0
0
Edgbaston
Query!
Country [320]
0
0
United Kingdom
Query!
State/province [320]
0
0
Hexham
Query!
Country [321]
0
0
United Kingdom
Query!
State/province [321]
0
0
Leicester
Query!
Country [322]
0
0
United Kingdom
Query!
State/province [322]
0
0
Liverpool
Query!
Country [323]
0
0
United Kingdom
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State/province [323]
0
0
London
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Hoffmann-La Roche
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
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.
Query!
Trial website
https://clinicaltrials.gov/study/NCT05878769
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Clinical Trials
Query!
Address
0
0
Hoffmann-La Roche
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Reference Study ID Number: GB43374 https://forpatients.roche.com/
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
888-662-6728
Query!
Fax
0
0
Query!
Email
0
0
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https://clinicaltrials.gov/study/NCT05878769
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