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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 | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

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

NCT06932263•AstraZeneca

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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
+3 more criteria

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.

Locations (208)

Research Site

Bakersfield, California, United States

Research Site

Huntington Beach, California, United States

Research Site

La Mesa, California, United States

Research Site

Newport Beach, California, United States

Research Site

San Jose, California, United States

Research Site

Wilmington, Delaware, United States

Research Site

Cutler Bay, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Hialeah, Florida, United States

Research Site

Leesburg, Florida, United States

Key Dates

Start Date

March 26, 2025

Primary Completion Date

June 24, 2027

Completion Date

March 16, 2028

Last Updated

March 4, 2026

Enrollment

540

ESTIMATED participants

Conditions

Asthma

Interventions

Tozorakimab

DRUG

Placebo

DRUG

Contacts

AstraZeneca Clinical Study Information Center

CONTACT

1-877-240-9479 information.center@astrazeneca.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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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

Inclusion Criteria

Exclusion Criteria

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