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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Astegolimab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring chronic obstructive pulmonary disease, COPD

Eligibility Criteria

40 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSRecruiting
  • Jasper Summit Research LLCRecruiting
  • Pulmonary Associates of Mobile PCRecruiting
  • Cadena Care Institute, LLCRecruiting
  • St Francis Medical Institute ClinEdge PPDSRecruiting
  • Flourish Research - Leesburg - PPDSRecruiting
  • Pulmonary Specialists of the Palm BeachesRecruiting
  • Florida Institute for Clinical Research, LLCRecruiting
  • Revive Research InstituteRecruiting
  • Oakland Medical ResearchRecruiting
  • Midwest Chest ConsultantsRecruiting
  • Midwest Clinical Research LLCRecruiting
  • Sierra Clinical Research - ClinEdge - PPDSRecruiting
  • Clinical Research of GastoniaRecruiting
  • Carolina Research CenterRecruiting
  • Southeastern Research CenterRecruiting
  • South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDSRecruiting
  • Sherman Clinical Research - ClinEdge - PPDSRecruiting
  • TrialsWest Pty LtdRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Open-Label Extension

Arm Description

Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study

Outcomes

Primary Outcome Measures

Incidence of all adverse events (AEs)

Secondary Outcome Measures

Full Information

First Posted
May 19, 2023
Last Updated
October 4, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT05878769
Brief Title
A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)
Official Title
A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 28, 2023 (Actual)
Primary Completion Date
June 30, 2027 (Anticipated)
Study Completion Date
June 30, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
chronic obstructive pulmonary disease, COPD

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Open-Label Extension
Arm Type
Experimental
Arm Description
Eligible participants from parent studies GB43311 and GB44332 will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W) until the end of the study
Intervention Type
Drug
Intervention Name(s)
Astegolimab
Intervention Description
Participants will receive SC astegolimab Q2W
Primary Outcome Measure Information:
Title
Incidence of all adverse events (AEs)
Time Frame
Up to 12 weeks after last dose of study treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: GB43374 https://forpatients.roche.com/
Phone
888-662-6728
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Individual Site Status
Recruiting
Facility Name
Jasper Summit Research LLC
City
Jasper
State/Province
Alabama
ZIP/Postal Code
35501
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonary Associates of Mobile PC
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608-3135
Country
United States
Individual Site Status
Recruiting
Facility Name
Cadena Care Institute, LLC
City
Poway
State/Province
California
ZIP/Postal Code
92064-2021
Country
United States
Individual Site Status
Recruiting
Facility Name
St Francis Medical Institute ClinEdge PPDS
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33765
Country
United States
Individual Site Status
Recruiting
Facility Name
Flourish Research - Leesburg - PPDS
City
Leesburg
State/Province
Florida
ZIP/Postal Code
34748-5077
Country
United States
Individual Site Status
Recruiting
Facility Name
Pulmonary Specialists of the Palm Beaches
City
Loxahatchee Groves
State/Province
Florida
ZIP/Postal Code
33470-9206
Country
United States
Individual Site Status
Recruiting
Facility Name
Florida Institute for Clinical Research, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32822
Country
United States
Individual Site Status
Recruiting
Facility Name
Revive Research Institute
City
Lathrup Village
State/Province
Michigan
ZIP/Postal Code
48076
Country
United States
Individual Site Status
Recruiting
Facility Name
Oakland Medical Research
City
Troy
State/Province
Michigan
ZIP/Postal Code
48085
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Chest Consultants
City
Saint Charles
State/Province
Missouri
ZIP/Postal Code
63301
Country
United States
Individual Site Status
Recruiting
Facility Name
Midwest Clinical Research LLC
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63141
Country
United States
Individual Site Status
Recruiting
Facility Name
Sierra Clinical Research - ClinEdge - PPDS
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106-4159
Country
United States
Individual Site Status
Recruiting
Facility Name
Clinical Research of Gastonia
City
Gastonia
State/Province
North Carolina
ZIP/Postal Code
28054
Country
United States
Individual Site Status
Recruiting
Facility Name
Carolina Research Center
City
Shelby
State/Province
North Carolina
ZIP/Postal Code
28150-3803
Country
United States
Individual Site Status
Recruiting
Facility Name
Southeastern Research Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103-4029
Country
United States
Individual Site Status
Recruiting
Facility Name
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDS
City
Boerne
State/Province
Texas
ZIP/Postal Code
78006-1993
Country
United States
Individual Site Status
Recruiting
Facility Name
Sherman Clinical Research - ClinEdge - PPDS
City
Sherman
State/Province
Texas
ZIP/Postal Code
75092
Country
United States
Individual Site Status
Recruiting
Facility Name
TrialsWest Pty Ltd
City
Spearwood
State/Province
Western Australia
ZIP/Postal Code
6163
Country
Australia
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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