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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

NCT06932263

RecruitingPhase 2

Sponsor: AstraZeneca

Conditions: Asthma

Interventions: Tozorakimab, Placebo

Countries: United States, Argentina, Brazil, Chile, China, France, Greece, Hungary

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 overview

Sex: ALL

Age: 18 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

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.

Locations (221)

Bakersfield, California, United States
Huntington Beach, California, United States
La Mesa, California, United States
Loma Linda, California, United States
Long Beach, California, United States
Newport Beach, California, United States
San Jose, California, United States
Wilmington, Delaware, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Leesburg, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
Orlando, Florida, United States
Palmetto Bay, Florida, United States
Tampa, Florida, United States
Winter Park, Florida, United States
Boise, Idaho, United States
Noblesville, Indiana, United States
West Des Moines, Iowa, United States
Hutchinson, Kansas, United States
Kansas City, Kansas, United States
Louisville, Kentucky, United States
White Marsh, Maryland, United States
Farmington Hills, Michigan, United States
Warren, Michigan, United States
St Louis, Missouri, United States
Bellevue, Nebraska, United States
Grand Island, Nebraska, United States
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