Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids

Part of paid clinical trials in Bakersfield, California.

Sponsor
AstraZeneca
Study ID
NCT06932263
Phase
PHASE2
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Tozorakimab — DRUG
    The drug will be administered subcutaneously.
  • Placebo — DRUG
    Placebo will be administered subcutaneously.

Study Details

This is a dose-range finding, double-blind, placebo-controlled, phase IIb study designed to assess efficacy and safety of tozorakimab administered subcutaneously in adult participants with uncontrolled asthma receiving medium-to-high dose inhaled corticosteroids.

Key Dates

Start date
Mar 26, 2025
Status verified
May 2026
Primary completion
Jun 24, 2027
Completion
Mar 16, 2028

Study Design

Enrollment
540 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

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

Primary Outcome Measure

Annualised rate of severe asthma exacerbations [ Time Frame: Over 26 to 52 weeks ]

Central Contacts

Locations (55)

FacilityCityStateZIPSite coordinators
Research SiteBakersfieldCalifornia93301-
Research SiteHuntington BeachCalifornia92647-
Research SiteLa MesaCalifornia91942-
Research SiteNewport BeachCalifornia92663-
Research SiteSan JoseCalifornia95117-
Research SiteWilmingtonDelaware19805-
Research SiteCutler BayFlorida33189-
Research SiteHialeahFlorida33012-
Research SiteHialeahFlorida33015-
Research SiteLeesburgFlorida34748-
Research SiteMiamiFlorida33155-
Research SiteMiamiFlorida33175-
Research SiteOrlandoFlorida32819-
Research SitePalmetto BayFlorida33157-
Research SiteTampaFlorida33607-
Research SiteWinter ParkFlorida32789-
Research SiteBoiseIdaho83706-
Research SiteNoblesvilleIndiana46060-
Research SiteWest Des MoinesIowa50266-
Research SiteHutchinsonKansas67502-
Research SiteKansas CityKansas66160-
Research SiteLouisvilleKentucky40218-
Research SiteWhite MarshMaryland21162-
Research SiteFarmington HillsMichigan48336-
Research SiteWarrenMichigan48088-
Research SiteSt LouisMissouri63141-
Research SiteBellevueNebraska68123-
Research SiteGrand IslandNebraska68803-
Research SiteOmahaNebraska68134-
Research SiteToms RiverNew Jersey08755-
Research SiteMaspethNew York11378-
Research SiteAshevilleNorth Carolina28803-
Research SiteHuntersvilleNorth Carolina28078-
Research SiteKings MountainNorth Carolina28086-
Research SitePinehurstNorth Carolina28374-
Research SiteToledoOhio43617-
Research SiteEdmondOklahoma73034-
Research SiteGrants PassOregon97527-
Research SiteMedfordOregon97504-
Research SitePortlandOregon97202-
Research SiteDuBoisPennsylvania15801-
Research SitePhiladelphiaPennsylvania19140-
Research SiteSmithfieldPennsylvania15478-
Research SiteRock HillSouth Carolina29732-
Research SiteKnoxvilleTennessee37919-
Research SiteAustinTexas78759-
Research SiteForneyTexas75126-
Research SiteKingwoodTexas77339-
Research SiteSugar LandTexas77478-
Research SiteTylerTexas75708-
Research SiteVictoriaTexas77901-
Research SiteRoyUtah84067-
Research SiteBellinghamWashington98225-
Research SiteKingwoodWest Virginia26537-
Research SiteMilwaukeeWisconsin53228-

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