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A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

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 evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05037929
Recruitment Status : Recruiting
First Posted : September 8, 2021
Last Update Posted : February 21, 2023
Sponsor:
Information provided by (Responsible Party):
Genentech, Inc.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Chronic Obstructive Pulmonary Disease Drug: Astegolimab Drug: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1290 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official 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
Actual Study Start Date : October 5, 2021
Estimated Primary Completion Date : January 1, 2025
Estimated Study Completion Date : March 1, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: COPD Lung Diseases

Arms and Interventions
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Arm Intervention/treatment
Experimental: Astegolimab Q2W
Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
 Drug: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Experimental: Astegolimab Q4W
Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
 Drug: Astegolimab
Participants will receive SC astegolimab Q2W or Q4W.
Placebo Comparator: Placebo
Participants will receive SC placebo Q2W.
 Drug: Placebo
Participants will receive SC placebo Q2W.


Outcome Measures
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Primary Outcome Measures :
  1. Annualized Rate of Moderate and Severe COPD Exacerbations Over the 52-Week Treatment Period [ Time Frame: Baseline up to Week 52 ]

Secondary Outcome Measures :
  1. Time to First Moderate or Severe COPD Exacerbation During the 52-Week Treatment Period [ Time Frame: Baseline up to Week 52 ]
  2. 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 [ Time Frame: Baseline to Week 52 ]
  3. Proportion of SGRQ-C Responders at Week 52 [ Time Frame: Baseline to Week 52 ]
  4. Absolute Change from Baseline in Post-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1) (liters) at Week 52 [ Time Frame: Baseline to Week 52 ]
  5. Absolute Change from Baseline in Evaluating Respiratory Symptoms in COPD (E-RS:COPD) Total Score at Week 52 [ Time Frame: Baseline to Week 52 ]
  6. Annualized Rate of Severe COPD Exacerbations Over the 52-Week Treatment Period [ Time Frame: Baseline up to Week 52 ]
  7. Absolute Change from Baseline in Five-Repetition Sit-to-Stand (5STS) time (seconds) at Week 52 [ Time Frame: Baseline to Week 52 ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05037929


Contacts
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Contact: Reference Study ID Number: GB43311 https://forpatients.roche.com/ 888-662-6728 global-roche-genentech-trials@gene.com

Locations
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Sponsors and Collaborators
Genentech, Inc.
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
More Information
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Responsible Party: Genentech, Inc.
ClinicalTrials.gov Identifier: NCT05037929    
Other Study ID Numbers: GB43311
First Posted: September 8, 2021    Key Record Dates
Last Update Posted: February 21, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Genentech, Inc.:
Chronic Obstructive Pulmonary Disease
COPD
Additional relevant MeSH terms:
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Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Respiratory Tract Diseases
Astegolimab
 Tumor Necrosis Factor Inhibitors
Anti-Inflammatory Agents
Antiviral Agents
Anti-Infective Agents