Efficacy and Safety of Tozorakimab in Symptomatic Chronic Obstructive Pulmonary Disease With a History of Exacerbations.

Part of paid clinical trials in Sheffield, Alabama.

Sponsor
AstraZeneca
Study ID
NCT05158387
Phase
PHASE3
Status
Completed

Conditions

  • Chronic Obstructive Pulmonary Disease (COPD)

Eligibility Criteria

Sex
ALL
Age
40 Years - 130 Years
Healthy Volunteers
Not accepted

Interventions

  • Tozorakimab — DRUG
    Administered subcutaneously tozorakimab Dose 1 and placebo through Week 52.
  • Tozorakimab — DRUG
    Administered subcutaneously tozorakimab Dose 2 through Week 52.
  • Placebo — DRUG
    Placebo administered subcutaneously, equivalent volume to tozorakimab through week 52.

Study Details

The purpose of this Phase III study is to evaluate the efficacy and safety of tozorakimab Dose 1 and Dose 2 administered subcutaneously (SC) in adult participants with symptomatic COPD and history of ≥ 2 moderate or ≥ 1 severe exacerbation of COPD in the previous 12 months. Participants should be receiving optimised treatment with maintenance inhaled therapy (ICS/LABA/LAMA triple therapy, or dual therapy if triple is not considered appropriate) in stable doses throughout at least 3 months prior to enrolment.

Key Dates

Start date
Feb 7, 2022
Status verified
Apr 2026
Primary completion
Jan 19, 2026
Completion
Mar 22, 2026

Study Design

Enrollment
1,172 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tozorakimab Dose 1
    Dosing subcutaneously tozorakimab Dose 1 and placebo
  • Experimental: Tozorakimab Dose 2
    Dosing subcutaneously tozorakimab Dose 2
  • Placebo Comparator: Placebo
    Dosing subcutaneously with equivalent volume to tozorakimab

Primary Outcome Measure

Annualized rate of moderate to severe COPD exacerbations in participants who are former smokers. [ Time Frame: over 52 weeks ]

Locations (34)

FacilityCityStateZIPSite coordinators
Research SiteSheffieldAlabama35660-
Research SiteLincolnCalifornia95648-
Research SiteNewport BeachCalifornia92663-
Research SiteNorthridgeCalifornia91324-
Research SiteColorado SpringsColorado80909-
Research SiteNewarkDelaware19713-
Research SiteBay PinesFlorida33744-
Research SiteCape CoralFlorida33990-
Research SitePensacolaFlorida32503-
Research SiteTampaFlorida33607-
Research SiteWinter ParkFlorida32789-
Research SiteMaconGeorgia31201-
Research SiteGreenwoodIndiana46143-
Research SiteBowling GreenKentucky42101-
Research SiteWhite MarshMaryland21162-
Research SiteNorth DartmouthMassachusetts02747-
Research SiteAnn ArborMichigan48109-
Research SiteFarmington HillsMichigan48336-
Research SiteGrand RapidsMichigan49546-
Research SiteBuffaloNew York14203-
Research SiteThe BronxNew York10459-
Research SiteToledoOhio43617-
Research SiteOklahoma CityOklahoma73104-
Research SiteTulsaOklahoma74133-
Research SitePhiladelphiaPennsylvania19140-
Research SiteRock HillSouth Carolina29732-
Research SiteAmarilloTexas79106-
Research SiteBoerneTexas78006-
Research SiteFort WorthTexas76104-
Research SiteMcKinneyTexas75069-
Research SiteTomballTexas77375-
Research SiteWebsterTexas77598-
Research SiteWilliamsburgVirginia23188-
Research SiteCudahyWisconsin53110-

Find similar trials in Sheffield, AL

By research site
Research Site· Sheffield, ALResearch Site· Lincoln, CAResearch Site· Newport Beach, CAResearch Site· Northridge, CAResearch Site· Colorado Springs, COResearch Site· Newark, DE

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