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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
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United States of America
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Alabama
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California
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Buenos Aires
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Caba
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Ciudad Autonoma Buenos Aires
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Lobos
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Mendoza
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Quilmes
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Belgium
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Edegem
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Romania
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Brasov
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Bucharest
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Cluj-Napoca
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Constanta
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Suceava
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South Africa
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City Of Tshwane
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Durban
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South Africa
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Ekurhuleni
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Kraaifontein
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Spain
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Badajoz
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Cantabria
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LA Coruña
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Barcelona
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Caceres
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Madrid
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Malaga
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Lidingö
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Lund
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Malmö
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Stockholm
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Bradford
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Cambridge
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Dundee
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Leicester
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United Kingdom
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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