A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)

Conditions

• Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex

ALL

Age

40 Years - 90 Years

Healthy Volunteers

Not accepted

Interventions

• Astegolimab — DRUG
  Participants will receive SC astegolimab Q2W

Study Details

The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.

Key Dates

Start date

Jun 28, 2023

Status verified

Jun 2026

Primary completion

Jul 1, 2034

Completion

Jul 1, 2034

Study Design

Enrollment

2,000 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Open-Label Extension
  Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Primary Outcome Measure

Incidence of all adverse events (AEs) [ Time Frame: Up to 12 weeks after last dose of study treatment ]

Central Contacts

• Reference Study ID Number: GB43374 https://forpatients.roche.com/
  888-662-6728
  [email protected]
• Fastest response: use the inquiry form. No email attachments. https://www.gene.com/contact-us/submit-medical-inquiry

Locations (68)

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