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

RecruitingPhase 2

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

Who can join

Ages 18 to 75 · All sexes

Full eligibility criteria
Inclusion Criteria:

1. Provision of signed and dated written informed consent prior to any study-specific procedures.
2. Adults aged 18-75, inclusive when signing the informed consent.
3. Documented physician-diagnosis of asthma for at least 12 months.
4. Treated with medium or high dose ICS in combination with LABA.
5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
7. Documented exacerbation history in the last 12 months and biomarker requirements of:

   1. ≥ 2 severe exacerbations OR
   2. 1 severe exacerbation and:

   (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
10. Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria:

1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
2. Clinically significant pulmonary disease other than asthma .
3. Current smokers, former smokers with \>10 pack-years history.
4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
6. Unstable cardiovascular disorders.

About the study

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.

What is being tested

Sponsor: AstraZeneca · Participants: 540 · Started: Mar 26, 2025

Contact the study team

Official record on ClinicalTrials.gov — NCT06932263

Locations in the U.S.

CaliforniaResearch Site, Bakersfield
Research Site, Newport Beach
Research Site, San Jose
IndianaResearch Site, Noblesville
KansasResearch Site, Hutchinson (Not yet recruiting)
KentuckyResearch Site, Louisville
MassachusettsResearch Site, Worcester (Not yet recruiting)
MichiganResearch Site, Farmington Hills
NebraskaResearch Site, Grand Island
Research Site, Omaha
New JerseyResearch Site, Millville (Not yet recruiting)
Research Site, Toms River
New YorkResearch Site, Horseheads (Not yet recruiting)
Research Site, Maspeth
North CarolinaResearch Site, Kings Mountain
OhioResearch Site, Toledo
OregonResearch Site, Medford
Research Site, Portland
PennsylvaniaResearch Site, Philadelphia
Research Site, Smithfield
South CarolinaResearch Site, Rock Hill
TexasResearch Site, Austin
Research Site, Boerne (Not yet recruiting)
Research Site, Dallas (Not yet recruiting)
Research Site, El Paso (Not yet recruiting)
Research Site, Greenville (Not yet recruiting)
Research Site, Kingwood
Research Site, McKinney (Not yet recruiting)
Research Site, Sugar Land (Not yet recruiting)
Research Site, Victoria
West VirginiaResearch Site, Kingwood
WisconsinResearch Site, Milwaukee

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.