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

Recruiting · NCT06932263 · Interventional (participants receive a specific treatment) · Lead sponsor: AstraZeneca

View the official record on ClinicalTrials.gov →

Interventions studied

PlaceboTozorakimab

What this trial is about

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.

Who can take part

Age range

18 Years to 75 Years

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 2

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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.

Exclusion criteria

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

60 locations listed across 26 US states.

Research Site - Bakersfield, California, United States
Research Site - Huntington Beach, California, United States
Research Site - La Mesa, California, United States
Research Site - Loma Linda, California, United States
Research Site - Long Beach, 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 - Leesburg, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami, Florida, United States
Research Site - Miami Lakes, Florida, United States
Research Site - Orlando, Florida, United States
Research Site - Palmetto Bay, Florida, United States
Research Site - Tampa, Florida, United States
Research Site - Winter Park, Florida, United States
Research Site - Boise, Idaho, United States
Research Site - Noblesville, Indiana, United States
Research Site - West Des Moines, Iowa, United States
Research Site - Hutchinson, Kansas, United States
Research Site - Kansas City, Kansas, United States
Research Site - Louisville, Kentucky, United States
Research Site - White Marsh, Maryland, United States
Research Site - Farmington Hills, Michigan, United States
Research Site - Warren, Michigan, United States
Research Site - St Louis, Missouri, United States
Research Site - Bellevue, Nebraska, United States
Research Site - Grand Island, Nebraska, United States
Research Site - Omaha, Nebraska, United States
Research Site - Toms River, New Jersey, United States
Research Site - Horseheads, New York, United States
Research Site - Maspeth, New York, United States
Research Site - Asheville, North Carolina, United States
Research Site - Huntersville, North Carolina, United States
Research Site - Kings Mountain, North Carolina, United States
Research Site - Pinehurst, North Carolina, United States
Research Site - Toledo, Ohio, United States
Research Site - Edmond, Oklahoma, United States
Research Site - Grants Pass, Oregon, United States
Research Site - Medford, Oregon, United States
Research Site - Portland, Oregon, United States
Research Site - DuBois, Pennsylvania, United States
Research Site - Philadelphia, Pennsylvania, United States
Research Site - Smithfield, Pennsylvania, United States
Research Site - Rock Hill, South Carolina, United States
Research Site - Knoxville, Tennessee, United States
Research Site - Austin, Texas, United States
Research Site - Boerne, Texas, United States
Research Site - Dallas, Texas, United States
Research Site - El Paso, Texas, United States
Research Site - Forney, Texas, United States
Research Site - Greenville, Texas, United States
Research Site - Kingwood, Texas, United States
Research Site - McKinney, Texas, United States
Research Site - Sugar Land, Texas, United States
Research Site - Tyler, Texas, United States
Research Site - Victoria, Texas, United States
Research Site - Roy, Utah, United States

Showing 60 of 221 listed sites. See the official record for the complete list.

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →