ClinicalTrials.Veeva

Menu
The trial is taking place at:
O

OK Clinical Research | Edmond, OK

Veeva-enabled site

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

Roche logo

Roche

Status and phase

Enrolling
Phase 3

Conditions

Chronic Obstructive Pulmonary Disease

Treatments

Drug: Astegolimab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05878769
GB43374

Details and patient eligibility

About

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.

Enrollment

2,000 estimated patients

Sex

All

Ages

40 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Completion of the 52-week treatment period in either parent GB43311 or GB44332

Exclusion criteria

  • Withdrawal of consent and/or premature discontinuation from parent study
  • Any permanent discontinuation of study drug in parent study
  • Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment
  • Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
  • Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study
  • Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

2,000 participants in 1 patient group

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

Trial contacts and locations

210

Loading...

Central trial contact

Reference Study ID Number: GB43374 https://forpatients.roche.com/

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems