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

Recruiting now · Phase 2 · Has a placebo group

Conditions studied: Asthma

In brief

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 facts

Study ID: NCT06932263
Run by: AstraZeneca
People needed: 540
Starts: 2025-03-26
Expected to finish: 2028-02-28
Last updated by the study team: 2026-07-20

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Provision of signed and dated written informed consent prior to any study-specific procedures.
Adults aged 18-75, inclusive when signing the informed consent.
Documented physician-diagnosis of asthma for at least 12 months.
Treated with medium or high dose ICS in combination with LABA.
Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
Documented exacerbation history in the last 12 months and biomarker requirements of:
2 severe exacerbations OR
1 severe exacerbation and:
(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if…

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

Where it is running

Research Site — Austin, Texas, United States (enrolling)
Research Site — Ciudad de Buenos Aires, Argentina (enrolling)
Research Site — Kings Mountain, North Carolina, United States (enrolling)
Research Site — Rock Hill, South Carolina, United States (enrolling)
Research Site — Kingwood, West Virginia, United States (enrolling)
Research Site — CABA, Argentina (enrolling)
Research Site — Grand Island, Nebraska, United States (enrolling)
Research Site — Maspeth, New York, United States (enrolling)
Research Site — Medford, Oregon, United States (enrolling)
Research Site — Smithfield, Pennsylvania, United States (enrolling)
Research Site — Kingwood, Texas, United States (enrolling)
Research Site — Victoria, Texas, United States (enrolling)
Research Site — San Jose, California, United States (enrolling)
Research Site — Milwaukee, Wisconsin, United States (enrolling)
Research Site — Bakersfield, California, United States (enrolling)
Research Site — Farmington Hills, Michigan, United States (enrolling)
Research Site — Omaha, Nebraska, United States (enrolling)
Research Site — Toms River, New Jersey, United States (enrolling)
Research Site — Noblesville, Indiana, United States (enrolling)
Research Site — Toledo, Ohio, United States (enrolling)
Research Site — Portland, Oregon, United States (enrolling)
Research Site — Philadelphia, Pennsylvania, United States (enrolling)
Research Site — Louisville, Kentucky, United States (enrolling)
Research Site — Newport Beach, California, United States (enrolling)
Research Site — La Plata, Argentina (enrolling)

Full record on ClinicalTrials.gov

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