A Study to Evaluate Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Phase 3

Recruiting

• Conditions: Chronic Obstructive Pulmonary Disease (COPD)
• Interventions: Drug: Astegolimab; Drug: Placebo

• Registration Number: NCT05595642
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

This study will evaluate the efficacy and safety of astegolimab compared with placebo in participants with chronic obstructive pulmonary disease (COPD) who are former or current smokers and have a history of frequent exacerbations.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Study First Posted: 2022-10-27
• Study Start: 2022-12-29
• Primary Completion: 2025-06-24
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-01
• Last Update Posted: 2025-09-03
• Study Completion: 2027-03-11

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1290

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Astegolimab SC Q2W	Astegolimab	Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
Astegolimab SC Q4W	Astegolimab	Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
Placebo SC Q2W	Placebo	Participants will receive SC placebo Q2W

Primary Outcome Measures

Name	Time	Method
Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period	52 weeks

Secondary Outcome Measures

Name	Time	Method
Time to first moderate or severe COPD exacerbation during the 52-week treatment period	52 weeks
Annualized rate of severe COPD exacerbations over the 52-week treatment period	52 weeks
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	Week 52
Absolute change from baseline in the Evaluating Respiratory Symptoms in Chronic Obstructive Pulmonary Disease (E-RS:COPD) total score at Week 52	Week 52
Proportion of participants with improvement in HRQoL at Week 52	Week 52
Absolute change from baseline in post-bronchodilator forced expiratory volume (FEV1) at Week 52	Week 52

Trial Locations

Locations (453)

Pinnacle Research Group; 🇺🇸 Anniston, Alabama, United States

AllerVie Clinical Research; 🇺🇸 Birmingham, Alabama, United States

Synexus Clinical Research US, Inc. - Birmingham; 🇺🇸 Birmingham, Alabama, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States

SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS; 🇺🇸 Dothan, Alabama, United States

Synexus Clinical Research US, Inc. - Phoenix West; 🇺🇸 Glendale, Arizona, United States

Pulmonary Associates; 🇺🇸 Phoenix, Arizona, United States

AES - DRS - Synexus Clinical Research US, Inc. - Tucson; 🇺🇸 Tucson, Arizona, United States

Lynn Institute of The Ozarks - ERN - PPDS; 🇺🇸 Little Rock, Arkansas, United States

Kern Research; 🇺🇸 Bakersfield, California, United States

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