NCT06932263From ClinicalTrials.govRecruiting

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

Asthma

At a glance

Phase: Phase 2
Study type: Interventional
Sponsor: AstraZeneca
Enrolment target: 540
Started: 26 March 2025
Main results due: 7 June 2027
Study sites: 222
Registry updated: 25 September 2026

Can you take part?

Ages 18 years to 75 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the 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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(222)

Research Site
Bakersfield, California, United States
Recruiting
Research Site
Huntington Beach, California, United States
Withdrawn
Research Site
La Mesa, California, United States
Terminated
Research Site
Loma Linda, California, United States
Withdrawn
Research Site
Long Beach, California, United States
Withdrawn
Research Site
Newport Beach, California, United States
Recruiting
Research Site
San Jose, California, United States
Recruiting
Research Site
Wilmington, Delaware, United States
Terminated
Research Site
Cutler Bay, Florida, United States
Suspended
Research Site
Hialeah, Florida, United States
Suspended
Research Site
Leesburg, Florida, United States
Withdrawn
Research Site
Miami, Florida, United States
Suspended
Research Site
Miami, Florida, United States
Suspended
Research Site
Miami Lakes, Florida, United States
Suspended
Research Site
Orlando, Florida, United States
Suspended
Research Site
Palmetto Bay, Florida, United States
Suspended
Research Site
Tampa, Florida, United States
Suspended
Research Site
Winter Park, Florida, United States
Suspended
Research Site
Boise, Idaho, United States
Withdrawn
Research Site
Noblesville, Indiana, United States
Recruiting
Research Site
West Des Moines, Iowa, United States
Terminated
Research Site
Hutchinson, Kansas, United States
Not yet recruiting
Research Site
Kansas City, Kansas, United States
Withdrawn
Research Site
Louisville, Kentucky, United States
Recruiting
Research Site
White Marsh, Maryland, United States
Withdrawn
Research Site
Worcester, Massachusetts, United States
Not yet recruiting
Research Site
Farmington Hills, Michigan, United States
Recruiting
Research Site
Warren, Michigan, United States
Withdrawn
Research Site
St Louis, Missouri, United States
Withdrawn
Research Site
Bellevue, Nebraska, United States
Withdrawn
Research Site
Grand Island, Nebraska, United States
Recruiting
Research Site
Omaha, Nebraska, United States
Recruiting
Research Site
Millville, New Jersey, United States
Not yet recruiting
Research Site
Toms River, New Jersey, United States
Recruiting
Research Site
Horseheads, New York, United States
Not yet recruiting
Research Site
Maspeth, New York, United States
Recruiting
Research Site
Asheville, North Carolina, United States
Withdrawn
Research Site
Huntersville, North Carolina, United States
Withdrawn
Research Site
Kings Mountain, North Carolina, United States
Recruiting
Research Site
Pinehurst, North Carolina, United States
Withdrawn
Research Site
Toledo, Ohio, United States
Recruiting
Research Site
Edmond, Oklahoma, United States
Withdrawn
Research Site
Grants Pass, Oregon, United States
Withdrawn
Research Site
Medford, Oregon, United States
Recruiting
Research Site
Portland, Oregon, United States
Recruiting
Research Site
DuBois, Pennsylvania, United States
Terminated
Research Site
Philadelphia, Pennsylvania, United States
Recruiting
Research Site
Smithfield, Pennsylvania, United States
Recruiting
Research Site
Rock Hill, South Carolina, United States
Recruiting
Research Site
Knoxville, Tennessee, United States
Terminated
Research Site
Austin, Texas, United States
Recruiting
Research Site
Boerne, Texas, United States
Not yet recruiting
Research Site
Dallas, Texas, United States
Not yet recruiting
Research Site
El Paso, Texas, United States
Not yet recruiting
Research Site
Forney, Texas, United States
Terminated
Research Site
Greenville, Texas, United States
Not yet recruiting
Research Site
Kingwood, Texas, United States
Recruiting
Research Site
McKinney, Texas, United States
Not yet recruiting
Research Site
Sugar Land, Texas, United States
Not yet recruiting
Research Site
Victoria, Texas, United States
Recruiting

Showing 60 of 222 sites — filter to narrow it down. 145 of the 222 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06932263. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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