Register a trial

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05037929




Registration number
NCT05037929
Ethics application status
Date submitted
31/08/2021
Date registered
8/09/2021

Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Scientific title
A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Secondary ID [1] 0 0
GB43311
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
Treatment: Drugs - Placebo

Experimental: Astegolimab Q2W - Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).

Experimental: Astegolimab Q4W - Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).

Placebo comparator: Placebo - Participants will receive SC placebo Q2W.


Treatment: Drugs: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.

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

Outcomes
Primary outcome [1] 0 0
Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [1] 0 0
Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period
Timepoint [1] 0 0
Baseline up to Week 52
Secondary outcome [2] 0 0
Absolute Change from Baseline in Health-Related Quality of Life (HRQoL) at Week 52 as Assessed Through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) Total Score
Timepoint [2] 0 0
Baseline to Week 52
Secondary outcome [3] 0 0
Proportion of SGRQ-C Responders at Week 52
Timepoint [3] 0 0
Baseline to Week 52
Secondary outcome [4] 0 0
Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52
Timepoint [4] 0 0
Baseline to Week 52
Secondary outcome [5] 0 0
Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52
Timepoint [5] 0 0
Baseline to Week 52
Secondary outcome [6] 0 0
Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period
Timepoint [6] 0 0
Baseline up to Week 52
Secondary outcome [7] 0 0
Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52
Timepoint [7] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
Inclusion Criteria

* Documented physician diagnosis of COPD for at least 12 months
* History of frequent exacerbations, defined as having had two or more moderate or severe exacerbations occurring within a 12-month period in the 24 months prior to screening
* Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score >=2
* Current or former smoker with a minimum of 10 pack-year history
* History of one of the following combinations of optimized, stable, standard-of-care COPD maintenance therapy for at least 4 weeks prior to screening, with no anticipated changes in therapy prior to initiation of study drug and throughout the study: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA); Long-acting muscarinic antagonist (LAMA) plus LABA; ICS plus LAMA plus LABA
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
* History of clinically significant pulmonary disease other than COPD
* History of long-term treatment with oxygen at >4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Participation in or planned participation in a new pulmonary rehabilitation program. Patients who are in the maintenance phase of a rehabilitation program are eligible
* History of lung transplant
* Occurrence of moderate or severe COPD exacerbation, COVID-19, upper or lower respiratory infection, pneumonia, or hospitalization of 24 hours duration within 4 weeks prior to initiation of study drug
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of a methylxanthine preparation, maintenance macrolide therapy, and/or PDE4 inhibitor within 4 weeks prior to screening
* Unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure within 12 months prior to screening

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
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
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
5/10/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
29/04/2025
Actual
Sample size
Target
1440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
Westmead Hospital - Westmead
Recruitment hospital [2] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [3] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [4] 0 0
TrialsWest Pty Ltd - Spearwood
Recruitment postcode(s) [1] 0 0
2145 - Westmead
Recruitment postcode(s) [2] 0 0
5042 - Bedford Park
Recruitment postcode(s) [3] 0 0
3128 - Box Hill
Recruitment postcode(s) [4] 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
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Massachusetts
Country [8] 0 0
United States of America
State/province [8] 0 0
Michigan
Country [9] 0 0
United States of America
State/province [9] 0 0
Missouri
Country [10] 0 0
United States of America
State/province [10] 0 0
Nevada
Country [11] 0 0
United States of America
State/province [11] 0 0
North Carolina
Country [12] 0 0
United States of America
State/province [12] 0 0
Pennsylvania
Country [13] 0 0
United States of America
State/province [13] 0 0
South Carolina
Country [14] 0 0
United States of America
State/province [14] 0 0
Texas
Country [15] 0 0
United States of America
State/province [15] 0 0
Virginia
Country [16] 0 0
Argentina
State/province [16] 0 0
Buenos Aires
Country [17] 0 0
Argentina
State/province [17] 0 0
Caba
Country [18] 0 0
Argentina
State/province [18] 0 0
Ciudad Autonoma Buenos Aires
Country [19] 0 0
Argentina
State/province [19] 0 0
Córdoba
Country [20] 0 0
Argentina
State/province [20] 0 0
Lobos
Country [21] 0 0
Argentina
State/province [21] 0 0
Mar Del Plata
Country [22] 0 0
Argentina
State/province [22] 0 0
Mendoza, Mendoza City
Country [23] 0 0
Argentina
State/province [23] 0 0
Mendoza
Country [24] 0 0
Argentina
State/province [24] 0 0
Quilmes
Country [25] 0 0
Argentina
State/province [25] 0 0
Rosario
Country [26] 0 0
Argentina
State/province [26] 0 0
San Fernando
Country [27] 0 0
Argentina
State/province [27] 0 0
San Miguel de Tucuman
Country [28] 0 0
Argentina
State/province [28] 0 0
San Miguel de Tucumán
Country [29] 0 0
Argentina
State/province [29] 0 0
Villa Vatteone
Country [30] 0 0
Belgium
State/province [30] 0 0
Edegem
Country [31] 0 0
Belgium
State/province [31] 0 0
Erpent
Country [32] 0 0
Belgium
State/province [32] 0 0
Leuven
Country [33] 0 0
Belgium
State/province [33] 0 0
Mechelen
Country [34] 0 0
Belgium
State/province [34] 0 0
Roeselare
Country [35] 0 0
Belgium
State/province [35] 0 0
Thuin
Country [36] 0 0
Belgium
State/province [36] 0 0
Yoir
Country [37] 0 0
Bulgaria
State/province [37] 0 0
Dupnitsa
Country [38] 0 0
Bulgaria
State/province [38] 0 0
Haskovo
Country [39] 0 0
Bulgaria
State/province [39] 0 0
Lovech
Country [40] 0 0
Bulgaria
State/province [40] 0 0
Pazardzhik
Country [41] 0 0
Bulgaria
State/province [41] 0 0
Pernik
Country [42] 0 0
Bulgaria
State/province [42] 0 0
Pleven
Country [43] 0 0
Bulgaria
State/province [43] 0 0
Plovdiv
Country [44] 0 0
Bulgaria
State/province [44] 0 0
Razgrad
Country [45] 0 0
Bulgaria
State/province [45] 0 0
Sofia
Country [46] 0 0
Bulgaria
State/province [46] 0 0
Stara Zagora
Country [47] 0 0
Bulgaria
State/province [47] 0 0
Vratsa
Country [48] 0 0
Canada
State/province [48] 0 0
Ontario
Country [49] 0 0
Canada
State/province [49] 0 0
Quebec
Country [50] 0 0
Canada
State/province [50] 0 0
Saskatchewan
Country [51] 0 0
Chile
State/province [51] 0 0
Curico
Country [52] 0 0
Chile
State/province [52] 0 0
Providencia
Country [53] 0 0
Chile
State/province [53] 0 0
Santiago
Country [54] 0 0
Chile
State/province [54] 0 0
Talca
Country [55] 0 0
Chile
State/province [55] 0 0
Valparaiso
Country [56] 0 0
Chile
State/province [56] 0 0
Ñuñoa
Country [57] 0 0
Czechia
State/province [57] 0 0
Jind?ich?v Hradec
Country [58] 0 0
Czechia
State/province [58] 0 0
Kralupy nad Vltavou
Country [59] 0 0
Czechia
State/province [59] 0 0
Miroslav
Country [60] 0 0
Czechia
State/province [60] 0 0
Tabor
Country [61] 0 0
Denmark
State/province [61] 0 0
Aalborg
Country [62] 0 0
Denmark
State/province [62] 0 0
Hellerup
Country [63] 0 0
Denmark
State/province [63] 0 0
Hvidovre
Country [64] 0 0
Denmark
State/province [64] 0 0
Odense C
Country [65] 0 0
Denmark
State/province [65] 0 0
Vejle
Country [66] 0 0
France
State/province [66] 0 0
Lyon
Country [67] 0 0
France
State/province [67] 0 0
Marseille
Country [68] 0 0
France
State/province [68] 0 0
Nice Cedex 1
Country [69] 0 0
France
State/province [69] 0 0
Strasbourg
Country [70] 0 0
Germany
State/province [70] 0 0
Augsburg
Country [71] 0 0
Germany
State/province [71] 0 0
Bamberg
Country [72] 0 0
Germany
State/province [72] 0 0
Berlin
Country [73] 0 0
Germany
State/province [73] 0 0
Deggingen
Country [74] 0 0
Germany
State/province [74] 0 0
Essen
Country [75] 0 0
Germany
State/province [75] 0 0
Frankfurt am Main
Country [76] 0 0
Germany
State/province [76] 0 0
Gießen
Country [77] 0 0
Germany
State/province [77] 0 0
Koblenz
Country [78] 0 0
Germany
State/province [78] 0 0
Landsberg
Country [79] 0 0
Germany
State/province [79] 0 0
Leipzig
Country [80] 0 0
Germany
State/province [80] 0 0
Mainz
Country [81] 0 0
Germany
State/province [81] 0 0
Marburg
Country [82] 0 0
Germany
State/province [82] 0 0
Peine
Country [83] 0 0
Hong Kong
State/province [83] 0 0
Hong Kong
Country [84] 0 0
Israel
State/province [84] 0 0
Ashdod
Country [85] 0 0
Israel
State/province [85] 0 0
Ashkelon
Country [86] 0 0
Israel
State/province [86] 0 0
Be'er Ya'akov
Country [87] 0 0
Israel
State/province [87] 0 0
Jerusalem
Country [88] 0 0
Israel
State/province [88] 0 0
Petach Tiqwa
Country [89] 0 0
Israel
State/province [89] 0 0
Ramat Gan
Country [90] 0 0
Israel
State/province [90] 0 0
Rehovot
Country [91] 0 0
Israel
State/province [91] 0 0
Tel Aviv-Yafo
Country [92] 0 0
Korea, Republic of
State/province [92] 0 0
Incheon
Country [93] 0 0
Korea, Republic of
State/province [93] 0 0
Jeollabuk-do
Country [94] 0 0
Korea, Republic of
State/province [94] 0 0
Seoul
Country [95] 0 0
Mexico
State/province [95] 0 0
Durango
Country [96] 0 0
Mexico
State/province [96] 0 0
Jalisco
Country [97] 0 0
Mexico
State/province [97] 0 0
Nuevo LEON
Country [98] 0 0
Netherlands
State/province [98] 0 0
Breda
Country [99] 0 0
Netherlands
State/province [99] 0 0
Eindhoven
Country [100] 0 0
Netherlands
State/province [100] 0 0
Hoorn
Country [101] 0 0
Netherlands
State/province [101] 0 0
Zwolle
Country [102] 0 0
New Zealand
State/province [102] 0 0
Auckland
Country [103] 0 0
New Zealand
State/province [103] 0 0
Christchurch
Country [104] 0 0
Peru
State/province [104] 0 0
Lima
Country [105] 0 0
Peru
State/province [105] 0 0
San Isidro
Country [106] 0 0
Poland
State/province [106] 0 0
Bydgoszcz
Country [107] 0 0
Poland
State/province [107] 0 0
Kielce
Country [108] 0 0
Poland
State/province [108] 0 0
Krakow
Country [109] 0 0
Poland
State/province [109] 0 0
Kraków
Country [110] 0 0
Poland
State/province [110] 0 0
Lublin
Country [111] 0 0
Poland
State/province [111] 0 0
Lódz
Country [112] 0 0
Poland
State/province [112] 0 0
Nowa Sól
Country [113] 0 0
Poland
State/province [113] 0 0
Ostrowiec Swietokrzysk
Country [114] 0 0
Poland
State/province [114] 0 0
Poznan
Country [115] 0 0
Poland
State/province [115] 0 0
Rzeszów
Country [116] 0 0
Poland
State/province [116] 0 0
Siedlce
Country [117] 0 0
Poland
State/province [117] 0 0
Sosnowiec
Country [118] 0 0
Poland
State/province [118] 0 0
Warszawa
Country [119] 0 0
Poland
State/province [119] 0 0
Wroclaw
Country [120] 0 0
Romania
State/province [120] 0 0
Brasov
Country [121] 0 0
Romania
State/province [121] 0 0
Bucharest
Country [122] 0 0
Romania
State/province [122] 0 0
Cluj-Napoca
Country [123] 0 0
Romania
State/province [123] 0 0
Constanta
Country [124] 0 0
Romania
State/province [124] 0 0
Suceava
Country [125] 0 0
South Africa
State/province [125] 0 0
Cape Town
Country [126] 0 0
South Africa
State/province [126] 0 0
City Of Tshwane
Country [127] 0 0
South Africa
State/province [127] 0 0
Durban
Country [128] 0 0
South Africa
State/province [128] 0 0
Ekurhuleni
Country [129] 0 0
South Africa
State/province [129] 0 0
Kraaifontein
Country [130] 0 0
Spain
State/province [130] 0 0
Badajoz
Country [131] 0 0
Spain
State/province [131] 0 0
Cantabria
Country [132] 0 0
Spain
State/province [132] 0 0
LA Coruña
Country [133] 0 0
Spain
State/province [133] 0 0
Barcelona
Country [134] 0 0
Spain
State/province [134] 0 0
Caceres
Country [135] 0 0
Spain
State/province [135] 0 0
Granada
Country [136] 0 0
Spain
State/province [136] 0 0
Madrid
Country [137] 0 0
Spain
State/province [137] 0 0
Malaga
Country [138] 0 0
Sweden
State/province [138] 0 0
Lidingö
Country [139] 0 0
Sweden
State/province [139] 0 0
Lund
Country [140] 0 0
Sweden
State/province [140] 0 0
Malmö
Country [141] 0 0
Sweden
State/province [141] 0 0
Stockholm
Country [142] 0 0
United Kingdom
State/province [142] 0 0
Bradford
Country [143] 0 0
United Kingdom
State/province [143] 0 0
Cambridge
Country [144] 0 0
United Kingdom
State/province [144] 0 0
Dundee
Country [145] 0 0
United Kingdom
State/province [145] 0 0
Leicester
Country [146] 0 0
United Kingdom
State/province [146] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Genentech, Inc.
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
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
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/NCT05037929