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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

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
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 5325738, California 5332921 93301

Research Site
Huntington Beach 5358705, California 5332921 92647

Research Site
La Mesa 5363990, California 5332921 91942

Research Site
Newport Beach 5376890, California 5332921 92663

Research Site
San Jose 5392171, California 5332921 95117

Research Site
Wilmington 4145381, Delaware 4142224 19805

Research Site
Cutler Bay 6332309, Florida 4155751 33189

Research Site
Hialeah 4158476, Florida 4155751 33012

Research Site
Hialeah 4158476, Florida 4155751 33015

Research Site
Miami 4164138, Florida 4155751 33155

Research Site
Miami 4164138, Florida 4155751 33175

Research Site
Orlando 4167147, Florida 4155751 32819

Research Site
Palmetto Bay 4167634, Florida 4155751 33157

Research Site
Tampa 4174757, Florida 4155751 33607

Research Site
Winter Park 4178560, Florida 4155751 32789

Research Site
Indianapolis 4259418, Indiana 4921868 46268

Research Site
West Des Moines 4881346, Iowa 4862182 50266

Research Site
Louisville 4299276, Kentucky 6254925 40218

Research Site
Farmington Hills 4992523, Michigan 5001836 48336

Research Site
St Louis 4407066, Missouri 4398678 63141

Research Site
Grand Island 5069297, Nebraska 5073708 68803

Research Site
Omaha 5074472, Nebraska 5073708 68134

Research Site
Toms River 4504476, New Jersey 5101760 08755

Research Site
Maspeth 5126180, New York 5128638 11378

Research Site
Kings Mountain 4474388, North Carolina 4482348 28086

Research Site
Toledo 5174035, Ohio 5165418 43617

Research Site
Medford 5740099, Oregon 5744337 97504

Research Site
Portland 5746545, Oregon 5744337 97202

Research Site
DuBois 5187432, Pennsylvania 6254927 15801

Research Site
Philadelphia 4560349, Pennsylvania 6254927 19140

Research Site
Smithfield 4561301, Pennsylvania 6254927 15478

Research Site
Rock Hill 4593142, South Carolina 4597040 29732

Research Site
Knoxville 4634946, Tennessee 4662168 37919

Research Site
Austin 4671654, Texas 4736286 78759

Research Site
Forney 4691833, Texas 4736286 75126

Research Site
Kingwood 7534469, Texas 4736286 77339

Research Site
Tyler 4738214, Texas 4736286 75708

Research Site
Victoria 4739157, Texas 4736286 77901

Research Site
Roy 5780802, Utah 5549030 84067

Research Site
Bellingham 5786899, Washington 5815135 98225

Research Site
Kingwood 4811007, West Virginia 4826850 26537

Research Site
Milwaukee 5263045, Wisconsin 5279468 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.

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