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

Purpose

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.

Condition

  • Asthma

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
This is a parallel-group treatment study with 3 arms. Participants will be randomised in a ratio of 1:1:1 to one of the 3 treatment arms.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Tozorakimab Dose 1 		Dosing subcutaneously tozorakimab Dose 1
  • Drug: Tozorakimab
    The drug will be administered subcutaneously.
Experimental
Tozorakimab Dose 2 		Dosing subcutaneously tozorakimab Dose 2 and placebo
  • Drug: Tozorakimab
    The drug will be administered subcutaneously.
Placebo Comparator
Placebo 		Dosing subcutaneously with equivalent volume to tozorakimab
  • Drug: Placebo
    Placebo will be administered subcutaneously.

Recruiting Locations

Research Site
Bakersfield, California 93301

Research Site
Huntington Beach, California 92647

Research Site
La Mesa, California 91942

Research Site
Newport Beach, California 92663

Research Site
San Jose, California 95117

Research Site
Wilmington, Delaware 19805

Research Site
Cutler Bay, Florida 33189

Research Site
Hialeah, Florida 33012

Research Site
Miami, Florida 33155

Research Site
Miami, Florida 33175

Research Site
Miami, Florida 33197

Research Site
Orlando, Florida 32819

Research Site
Palmetto Bay, Florida 33157

Research Site
Tampa, Florida 33607

Research Site
Indianapolis, Indiana 46268

Research Site
West Des Moines, Iowa 50266

Research Site
Louisville, Kentucky 40218

Research Site
Farmington Hills, Michigan 48336

Research Site
Grand Island, Nebraska 68803

Research Site
Omaha, Nebraska 68134

Research Site
Toms River, New Jersey 08755

Research Site
Maspeth, New York 11378

Research Site
Kings Mountain, North Carolina 28086

Research Site
Toledo, Ohio 43617

Research Site
Medford, Oregon 97504

Research Site
Portland, Oregon 97202

Research Site
DuBois, Pennsylvania 15801

Research Site
Smithfield, Pennsylvania 15478

Research Site
Rock Hill, South Carolina 29732

Research Site
Knoxville, Tennessee 37919

Research Site
Austin, Texas 78759

Research Site
Forney, Texas 75126

Research Site
Kingwood, Texas 77339

Research Site
Tyler, Texas 75708

Research Site
Victoria, Texas 77901

Research Site
Bellingham, Washington 98225

Research Site
Kingwood, West Virginia 26537

Research Site
Milwaukee, Wisconsin 53228

More Details

NCT ID
NCT06932263
Status
Recruiting
Sponsor
AstraZeneca

Study Contact

AstraZeneca Clinical Study Information Center
1-877-240-9479
information.center@astrazeneca.com

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Vanderbilt University Medical Center