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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

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
NA
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
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Arizona
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California
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Florida
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Georgia
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Indiana
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Louisiana
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Maine
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Massachusetts
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Michigan
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Missouri
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Nevada
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North Carolina
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Virginia
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Washington
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Argentina
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Buenos Aires
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Argentina
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Caba
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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
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Argentina
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Mar Del Plata
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Argentina
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Mendoza, Mendoza City
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Argentina
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Mendoza
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Argentina
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Quilmes
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Argentina
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Rosario
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Argentina
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San Fernando
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Argentina
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San Miguel de Tucuman
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Argentina
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San Miguel de Tucumán
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Argentina
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Villa Vatteone
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Belgium
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Edegem
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Erpent
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Leuven
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Roeselare
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Thuin
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Yoir
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Lovech
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Montana
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Pazardzhik
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Pleven
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Kralupy nad Vltavou
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Frankfurt am Main
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Peine
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Ashdod
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Petach Tiqwa
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Ramat Gan
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Rehovot
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Israel
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Tel Aviv-Yafo
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Korea, Republic of
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Incheon
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Jeollabuk-do
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Brasov
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Cape Town
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City Of Tshwane
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Ekurhuleni
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Johannesburg
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Kempton Park
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Kraaifontein
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Pretoria
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Spain
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Badajoz
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LA Coruña
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Caceres
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Granada
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Madrid
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Malaga
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Lidingö
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Stockholm
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United Kingdom
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Bradford
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United Kingdom
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Leicester

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
[email protected]
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).
When will data be available (start and end dates)?
Available to whom?
Available for what types of analyses?
How or where can data be obtained?


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05878769