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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

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

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

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

Arm	Description	Assigned 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

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Newport Beach, California 92663

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San Jose, California 95117

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Wilmington, Delaware 19805

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Cutler Bay, Florida 33189

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Hialeah, Florida 33012

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Miami, Florida 33155

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Miami, Florida 33175

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Miami, Florida 33197

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Orlando, Florida 32819

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Palmetto Bay, Florida 33157

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Tampa, Florida 33607

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Indianapolis, Indiana 46268

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West Des Moines, Iowa 50266

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Louisville, Kentucky 40218

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Farmington Hills, Michigan 48336

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Grand Island, Nebraska 68803

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Omaha, Nebraska 68134

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Toms River, New Jersey 08755

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Maspeth, New York 11378

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Kings Mountain, North Carolina 28086

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Toledo, Ohio 43617

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Medford, Oregon 97504

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Portland, Oregon 97202

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DuBois, Pennsylvania 15801

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Smithfield, Pennsylvania 15478

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Rock Hill, South Carolina 29732

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Knoxville, Tennessee 37919

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Austin, Texas 78759

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Forney, Texas 75126

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Kingwood, Texas 77339

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Tyler, Texas 75708

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Victoria, Texas 77901

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Bellingham, Washington 98225

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Kingwood, West Virginia 26537

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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

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.