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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05595642




Registration number
NCT05595642
Ethics application status
Date submitted
24/10/2022
Date registered
27/10/2022

Titles & IDs
Public title
A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease
Scientific title
A Phase III, 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
GB44332
Universal Trial Number (UTN)
Trial acronym
ARNASA
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease (COPD) 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 SC Q2W - Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)

Experimental: Astegolimab SC Q4W - Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.

Placebo comparator: Placebo SC Q2W - 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
52 weeks
Secondary outcome [1] 0 0
Time to first moderate or severe COPD exacerbation during the 52-week treatment period
Timepoint [1] 0 0
52 weeks
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
Week 52
Secondary outcome [3] 0 0
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52
Timepoint [3] 0 0
Week 52
Secondary outcome [4] 0 0
Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52
Timepoint [4] 0 0
Week 52
Secondary outcome [5] 0 0
Proportion of participants with improvement in HRQoL at Week 52
Timepoint [5] 0 0
Week 52
Secondary outcome [6] 0 0
Annualized rate of severe COPD exacerbations over the 52-week treatment period
Timepoint [6] 0 0
52 weeks

Eligibility
Key inclusion criteria
Inclusion Criteria

* Documented COPD diagnosis for = 12 months
* History of frequent exacerbations, defined as having had 2 or more moderate or severe COPD exacerbations within 12 months prior to screening
* Post-bronchodilator FEV1 = 20% and < 80% of predicted at screening
* Post-bronchodilator FEV1/FVC < 0.70 at screening
* Modified Medical Research Council (dyspnea scale) (mMRC) score = 2
* Current tobacco smoker or former smoker with a history of smoking = 10 pack-years
* On optimized COPD maintenance therapy as defined below for = 12 months prior to screening, and stable on current therapy for at least 4 weeks prior to screening: Inhaled corticosteroid (ICS) plus long-acting beta-agonist (LABA), Long-acting muscarinic antagonist (LAMA) plus LABA, ICS plus LAMA plus LABA
* Chest X-ray or computed tomography (CT) scan within 6 months prior to screening or chest X-ray during the screening period that confirms the absence of clinically significant lung disease besides COPD
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria

* Current documented diagnosis of asthma
* History of clinically significant pulmonary disease other than COPD
* Diagnosis of 1-antitrypsin deficiency
* History of long-term treatment with oxygen at > 4.0 liters/minute
* Lung volume reduction surgery or procedure within 12 months prior to screening
* Individuals participating in, or scheduled for, an intensive COPD rehabilitation program (participants who are in the maintenance phase of a rehabilitation program are eligible)
* History of lung transplant
* Any infection that resulted in hospital admission for = 24 hours and/or treatment with oral, IV, or IM antibiotics within 4 weeks prior to or during screening
* Upper or lower respiratory tract infection within 4 weeks prior to or during screening
* Treatment with oral, IV, or IM corticosteroids within 4 weeks prior to initiation of study drug
* Initiation of or change in non-biologic immunomodulatory or immunosuppressive therapy within 3 months 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 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
29/12/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/06/2025
Actual
Sample size
Target
1290
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,WA
Recruitment hospital [1] 0 0
Royal Adelaide Hospital - Adelaide
Recruitment hospital [2] 0 0
Institute for Respiratory Health Inc - Nedlands
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
6009 - Nedlands
Recruitment outside Australia
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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: GB44332 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/NCT05595642