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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT05037929
Ethics application status
Date submitted
31/08/2021
Date registered
8/09/2021
Date last updated
29/09/2021

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

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
Gender
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
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC,WA
Recruitment hospital [1] 0 0
John Hunter Hospital - New Lambton
Recruitment hospital [2] 0 0
Westmead Hospital - Westmead
Recruitment hospital [3] 0 0
The Queen Elizabeth Hospital - Adelaide
Recruitment hospital [4] 0 0
Flinders Medical Centre - Bedford Park
Recruitment hospital [5] 0 0
Box Hill Hospital - Box Hill
Recruitment hospital [6] 0 0
TrialsWest Pty Ltd - Spearwood
Recruitment postcode(s) [1] 0 0
2305 - New Lambton
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5011 - Adelaide
Recruitment postcode(s) [4] 0 0
5042 - Bedford Park
Recruitment postcode(s) [5] 0 0
3128 - Box Hill
Recruitment postcode(s) [6] 0 0
6163 - Spearwood
Recruitment outside Australia
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LA Coruña
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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
This study will evaluate the efficacy, safety, and pharmacokinetics of astegolimab in
combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance
therapy in patients with COPD who are former or current smokers and have a history of
frequent exacerbations.
Trial website
https://clinicaltrials.gov/show/NCT05037929
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: GB43311 www.roche.com/about_roche/roche_worldwide.htm
Address 0 0
Country 0 0
Phone 0 0
888-662-6728
Fax 0 0
Email 0 0
global-roche-genentech-trials@gene.com
Contact person for scientific queries

Summary results
For IPD and results data, please see https://clinicaltrials.gov/show/NCT05037929