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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Hoffmann-La Roche
Study ID
NCT05595642
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Astegolimab — DRUG
    Participants will receive SC astegolimab Q2W or Q4W
  • Placebo — DRUG
    Participants will receive SC placebo Q2W

Study Details

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.

Key Dates

Start date
Dec 29, 2022
Status verified
May 2026
Primary completion
Jun 24, 2025
Completion
Sep 24, 2027

Study Design

Enrollment
1,290 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Astegolimab SC Q2W
    Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W)
  • Experimental: Astegolimab SC Q4W
    Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving SC astegolimab Q4W.
  • Placebo Comparator: Placebo SC Q2W
    Participants will receive SC placebo Q2W

Primary Outcome Measure

Annualized rate of moderate and severe COPD exacerbations over the 52-week treatment period [ Time Frame: 52 weeks ]

Locations (53)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothanAlabama36305-
Pulmonary Associates PAGlendaleArizona85306-4669-
AES - DRS - Synexus Clinical Research US, Inc. - TucsonTucsonArizona85741-3118-
Kern ResearchBakersfieldCalifornia93301-
Allergy & Asthma Medical Group of the Bay AreaWalnut CreekCalifornia94598-
Finlay Medical Research CorporationGreenacres CityFlorida33467-2979-
Avantis Clinical Research, LLCMiamiFlorida33155-3265-
Diverse Clinical Research, LLCMiamiFlorida33175-3434-
Oceane7 Medical & Research Center, Inc.MiamiFlorida33144-2155-
Research Institute of South Florida IncMiamiFlorida33173-
San Marcus Research Clinic Inc.MiamiFlorida33014-
Central Florida Pulmonary Group, PAOrlandoFlorida32803-
AES - DRS - Synexus Clinical Research US, Inc. - The VillagesThe VillagesFlorida32162-7116-
AES - DRS - Synexus Clinical Research US, Inc. - AtlantaAtlantaGeorgia30328-
Allergy Center at Brookstone Research - Centricity Research - HyperCore - PPDColumbusGeorgia31904-2954-
Pivotal Research SolutionsStonecrestGeorgia30038-2649-
ASHA Clinical Research - ClinEdge - PPDSHammondIndiana46324-2213-
The Research Group of Lexington, LLCLexingtonKentucky40504-
Best Clinical TrialsNew OrleansLouisiana70115-
Paul A. Shapero, MD, PABangorMaine04401-5691-
Pulmonary Research Institute of Southeast MichiganFarmington HillsMichigan48336-2817-
Flushing Road Internal Medicine and Pediatrics - FFlintMichigan48504-4730-
Revive Research InstituteLathrup VillageMichigan48076-
Oakland Medical Research CenterTroyMichigan48085-5524-
Washington University School of Medicine in St. LouisSt LouisMissouri63110-
Nebraska Medical Research Institute, Inc. - CRNBellevueNebraska68123-4318-
Machuca Family MedicineLas VegasNevada89104-3953-
Renown Regional Medical Center HospitalRenoNevada89502-1576-
Hassman Research Institute - HRI - Berlin - CenExel - PPDSMarltonNew Jersey08053-
AES - DRS - Synexus Clinical Research US, Inc. - New YorkNew YorkNew York10017-4008-
Research Carolina EliteDenverNorth Carolina28037-7929-
Pulmonix LLCGreensboroNorth Carolina27403-
Advanced Respiratory and Sleep Medicine, PLLCHuntersvilleNorth Carolina28078-
Southeastern Research CenterWinston-SalemNorth Carolina27103-4029-
OK Clinical ResearchEdmondOklahoma73034-3258-
The Oregon ClinicPortlandOregon97213-
Clinical Research Associates Of Central Pa , LlcAltoonaPennsylvania16602-
Allergy & Clinical Immun AssocPittsburghPennsylvania15241-
Medtrial, LLCColumbiaSouth Carolina29204-
Velocity Clinical Research - Gaffney - PPDSGaffneySouth Carolina29340-4737-
ClinSearch, LLCChattanoogaTennessee37421-
Clinical Trials Center of Middle TennesseeFranklinTennessee37067-5603-
Tennessee Comprehensive Lung & Sleep CenterHendersonvilleTennessee37075-3085-
TTS ResearchBoerneTexas78006-
Corsicana Medical ResearchCorsicanaTexas75110-2471-
Baylor College of Medicine Medical CenterHoustonTexas77030-
Biopharma Informatic - Park Row - PPDSHoustonTexas77084-
Trio Clinical TrialsHoustonTexas77008-
R & H Clinical ResearchKatyTexas77494-2031-
University of Vermont Medical CenterBurlingtonVermont05401-
Western Washington Medical GroupEverettWashington98208-
Allergy Asthma and Sinus Center-GreenfieldGreenfieldWisconsin53228-3467-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALSEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS· Dothan, ALPulmonary Associates PA· Glendale, AZAES - DRS - Synexus Clinical Research US, Inc. - Tucson· Tucson, AZKern Research· Bakersfield, CAAllergy & Asthma Medical Group of the Bay Area· Walnut Creek, CA

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