A Study to Evaluate the Efficacy and Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease

Part of paid clinical trials in Dothan, Alabama.

Sponsor
Genentech, Inc.
Study ID
NCT05037929
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
40 Years - 90 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, safety, and pharmacokinetics of astegolimab in combination with standard of care chronic obstructive pulmonary disease (COPD) maintenance therapy in patients with COPD who are former or current smokers and have a history of frequent exacerbations.

Key Dates

First listed
Sep 8, 2021
Start date
Oct 5, 2021
Status verified
Feb 2026
Primary completion
Feb 24, 2025
Completion
Jul 7, 2025

Study Design

Enrollment
1,334 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Astegolimab Q2W
    Participants will receive subcutaneous (SC) astegolimab every 2 weeks (Q2W).
  • Experimental: Astegolimab Q4W
    Participants will receive alternating SC astegolimab and placebo Q2W, thus receiving astegolimab every 4 weeks (Q4W).
  • Placebo Comparator: Placebo
    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: Baseline up to Week 52 ]

Locations (34)

FacilityCityStateZIPSite coordinators
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDSDothanAlabama36305-
Jasper Summit Research LLCJasperAlabama35501-
Pulmonary Associates of Mobile PCMobileAlabama36608-3135-
Cadena Care Institute, LLCPowayCalifornia92064-2021-
Inst. of Healthcare Assessment, Inc.San DiegoCalifornia92120-
Allianz Research Institute IncWestminsterCalifornia92683-
National Jewish HealthDenverColorado80206-
Clinical Site Partners - Leesburg Suite 101 - HyperCore - PPDSLeesburgFlorida34748-5077-
Florida Institute for Clinical Research, LLCOrlandoFlorida32825-4454-
Clinical Site Partners - Winter Park - HyperCore - PPDSWinter ParkFlorida32789-4681-
Northwestern Center for Clinical ResearchChicagoIllinois60611-
Medisphere Medical Research Center, LlcEvansvilleIndiana47714-
Exordia Medical Research, Inc.Fall RiverMassachusetts20723-
Northern Pines Health Center PCBuckleyMichigan49620-
Revive Research InstituteLathrup VillageMichigan48076-
Cardio-Pulmonary AssociatesChesterfieldMissouri63017-3627-
Blessing Health HannibalHannibalMissouri63401-
Midwest Chest ConsultantsSaint CharlesMissouri63301-
CARE Clinical ResearchSt LouisMissouri63141-6823-
Midwest Clinical Research LLCSt LouisMissouri63141-
Sierra Clinical Research - ClinEdge - PPDSLas VegasNevada89106-4159-
American Health Research Inc.CharlotteNorth Carolina28277-
Clinical Research of GastoniaGastoniaNorth Carolina28054-7481-
Carolina Research CenterShelbyNorth Carolina28150-3803-
Southeastern Research CenterWinston-SalemNorth Carolina27103-4029-
Temple University HospitalPhiladelphiaPennsylvania19140-
Lowcountry Lung and Critical CareNorth CharlestonSouth Carolina29406-
Clinical Research of Rock HillRock HillSouth Carolina29732-1160-
Spartanburg Medical CenterSpartanburgSouth Carolina29303-
Velocity Clinical Research Spartanburg PPDSSpartanburgSouth Carolina29303-4225-
South Texas Medical Research Institute, Inc., dba TTS Research ? ClinEdge ? PPDSBoerneTexas78006-1993-
Baylor College of MedicineHoustonTexas77030-
Metroplex Pulmonology & Sleep CenterMcKinneyTexas75069-
Sherman Clinical Research - ClinEdge - PPDSShermanTexas75092-

Find similar trials in Dothan, AL

Nationwide
COPD trialsPulmonology trialsLung disease trials
By condition
COPD
By specialty
PulmonologyLung disease
By research site
SEC Clinical Research LLC - Dothan 2 - ClinEdge - PPDS· Dothan, ALJasper Summit Research LLC· Jasper, ALPulmonary Associates of Mobile PC· Mobile, ALCadena Care Institute, LLC· Poway, CAInst. of Healthcare Assessment, Inc.· San Diego, CAAllianz Research Institute Inc· Westminster, CA

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