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Clinical Trials in India / NCT06932263
Recruiting Phase 2

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

NCT06932263 · tracked via the Priya Life Science India tracker
Sponsor
AstraZeneca
Phase
Phase 2
Started
2025-03-26
Last updated
2026-07-20

Condition(s) studied

Asthma

Investigational drug(s) / intervention(s)

TozorakimabPlacebo

Tozorakimab: The drug will be administered subcutaneously.

Placebo: Placebo will be administered subcutaneously.

Study summary

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

Sex
ALL
Min age
18 Years
Max age
75 Years
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.

Primary outcome measure(s)

Trial sites (221)

FacilityCityRegionStatus
Research Site Bakersfield California Recruiting
Research Site Huntington Beach California Withdrawn
Research Site La Mesa California Terminated
Research Site Loma Linda California Withdrawn
Research Site Long Beach California Withdrawn
Research Site Newport Beach California Recruiting
Research Site San Jose California Recruiting
Research Site Wilmington Delaware Terminated
Research Site Cutler Bay Florida Suspended
Research Site Hialeah Florida Suspended
Research Site Leesburg Florida Withdrawn
Research Site Miami Florida Suspended
Research Site Miami Florida Suspended
Research Site Miami Lakes Florida Suspended
Research Site Orlando Florida Suspended
Research Site Palmetto Bay Florida Suspended
Research Site Tampa Florida Suspended
Research Site Winter Park Florida Suspended
Research Site Boise Idaho Withdrawn
Research Site Noblesville Indiana Recruiting
Research Site West Des Moines Iowa Terminated
Research Site Hutchinson Kansas Not Yet Recruiting
Research Site Kansas City Kansas Withdrawn
Research Site Louisville Kentucky Recruiting
Research Site White Marsh Maryland Withdrawn
Research Site Farmington Hills Michigan Recruiting
Research Site Warren Michigan Withdrawn
Research Site St Louis Missouri Withdrawn
Research Site Bellevue Nebraska Withdrawn
Research Site Grand Island Nebraska Recruiting
Research Site Omaha Nebraska Recruiting
Research Site Toms River New Jersey Recruiting
Research Site Horseheads New York Not Yet Recruiting
Research Site Maspeth New York Recruiting
Research Site Asheville North Carolina Withdrawn
Research Site Huntersville North Carolina Withdrawn
Research Site Kings Mountain North Carolina Recruiting
Research Site Pinehurst North Carolina Withdrawn
Research Site Toledo Ohio Recruiting
Research Site Edmond Oklahoma Withdrawn

+ 181 more sites — see the full list on the official registry below.

More AstraZeneca trials in India

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06932263 on ClinicalTrials.gov ↗ ← All trials in India