Recruiting
Phase 2

Tozorakimab

Sponsor:

AstraZeneca

Code:

NCT06932263

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Tozorakimab

Placebo

Study Details

Brief 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.

Conditions

Asthma

Study ID

NCT06932263

Start date

Mar 26, 2025

Status verified date

Aug, 2026

Completion date

Feb 28, 2028

Anticipated

Primary completion date

Jun 7, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

540 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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

Interventions

Tozorakimab

The drug will be administered subcutaneously.

Placebo

Placebo will be administered subcutaneously.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

AstraZeneca Clinical Study Information Center

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

Locations

Research Site

Recruiting

Bakersfield, California, United States, 93301

Research Site

Recruiting

Newport Beach, California, United States, 92663

Research Site

Recruiting

San Jose, California, United States, 95117

Research Site

Recruiting

Noblesville, Indiana, United States, 46060

Research Site

Recruiting

Louisville, Kentucky, United States, 40218

Research Site

Recruiting

Farmington Hills, Michigan, United States, 48336

Research Site

Recruiting

Grand Island, Nebraska, United States, 68803

Research Site

Recruiting

Omaha, Nebraska, United States, 68134

Research Site

Recruiting

Toms River, New Jersey, United States, 08755

Research Site

Recruiting

Maspeth, New York, United States, 11378

Research Site

Recruiting

Kings Mountain, North Carolina, United States, 28086

Research Site

Recruiting

Toledo, Ohio, United States, 43617

Research Site

Recruiting

Medford, Oregon, United States, 97504

Research Site

Recruiting

Portland, Oregon, United States, 97202

Research Site

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Research Site

Recruiting

Smithfield, Pennsylvania, United States, 15478

Research Site

Recruiting

Rock Hill, South Carolina, United States, 29732

Research Site

Recruiting

Austin, Texas, United States, 78759

Research Site

Recruiting

Kingwood, Texas, United States, 77339

Research Site

Recruiting

Victoria, Texas, United States, 77901

Research Site

Recruiting

Kingwood, West Virginia, United States, 26537

Research Site

Recruiting

Milwaukee, Wisconsin, United States, 53228

More Information

Sponsor

AstraZeneca

Last update posted

Sep 25, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-27. This information was provided to ClinicalTrials.gov by AstraZeneca on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.