A Study to Evaluate the Efficacy and Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease (COPD)

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Genentech Inc.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Phenomena and Processes [G] - Immune System Phenomena [G13], Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

27 Jan 2022 → 7 Jul 2025

Decision date (initial)

2024-04-11

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Genentech Inc.

External identifiers

EU CT number

2023-507093-40-00

EudraCT number

2021-002045-15

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Efficacy, Others, Safety, Pharmacokinetic

To evaluate the effect of astegolimab compared with placebo, on annualized rate of moderate and severe acute exacerbations of COPD over 52 weeks of treatment

Secondary objectives 8

1. To evaluate the effect of astegolimab compared with placebo on time to first moderate or severe COPD exacerbation
2. To evaluate the effect of astegolimab compared with placebo on St George’s Respiratory Questionnaire
3. To evaluate the effect of astegolimab compared with placebo on post-bronchodilator forced expiratory volume in 1 second (FEV1)
4. To evaluate the effect of astegolimab compared with placebo on Evaluating Respiratory Symptoms in COPD (E-RS:COPD)
5. To evaluate the effect of astegolimab compared with placebo on annualized rate of severe COPD exacerbations
6. To evaluate the effects of astegolimab compared with placebo on safety
7. To characterize the astegolimab PK profile
8. To evaluate the immune response to astegolimab

Conditions and MedDRA coding

Chronic Obstructive Pulmonary Disease (COPD)

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

No

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Age 40-90 years
2. Documented physician diagnosis of COPD for at least 12 months
3. 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
4. Post-bronchodilator FEV1 >=20 and <80% of predicted normal value at screening
5. Current or former smoker with a minimum of 10 pack-year history
6. 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

Exclusion criteria 6

1. Current documented diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines within 5 years prior to screening
2. History of clinically significant pulmonary disease other than COPD (e.g. pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency)
3. Lung volume reduction surgery or procedure within 12 months prior to screening
4. History of lung transplant
5. 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
6. History of long-term treatment with oxygen at > 4.0 liters/minute. While breathing supplemental oxygen, patient should demonstrate an oxyhemoglobin saturation of >= 89%

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. 1. Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period

Secondary endpoints 10

1. 1.Time to first moderate or severe COPD exacerbation during the 52-week treatment period
2. 2. Absolute change from baseline in HRQoL at Week 52, as assessed through the St. George's Respiratory Questionnaire-COPD (SGRQ-C) total score
3. 3. Proportion of patients with improvement in HRQoL, defined as a decrease from baseline of >/=4 points in SGRQ-C total score, at Week 52
4. 4. Absolute change from baseline in post-bronchodilator FEV1 (liters) at Week 52
5. 5. Absolute change from baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) total score at Week 52
6. 6. Annualized rate of severe COPD exacerbations over the 52-week treatment period
7. 7. Absolute change from baseline in five-repetition sit-to-stand test (5STS) time (seconds) at Week 52
8. 8. Incidence and severity of adverse events
9. 9. Serum concentration of astegolimab at specified timepoints
10. 10. Prevalence of anti-drug antibodies (ADAs) at baseline and incidence of ADAs during the study

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Placebo 1

Auxiliary 3

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Genentech Inc.

Sponsor organisation

Genentech Inc.

Address

1 Dna Way

City

South San Francisco

Postcode

94080-4918

Country

United States

Scientific contact point

Organisation

Genentech Inc.

Contact name

US Program Manager Product Development Regulatory

Public contact point

Organisation

Genentech Inc.

Contact name

US Program Manager Product Development Regulatory

Third parties 10

Locations

11 EU/EEA countries · 84 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Layperson summary Annex V

Documents 167 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

5 submissions — initial application plus substantial / non-substantial modifications