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

Description

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.

Conditions

Asthma

Study Overview

Study Details

Study overview

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.

A Phase IIb, Multicentre, Double-blind, Placebo-controlled Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adult Participants With Uncontrolled Asthma on Medium-to High Dose Inhaled Corticosteroids

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

Condition
Asthma
Intervention / Treatment

-

Contacts and Locations

Bakersfield

Research Site, Bakersfield, California, United States, 93301

Huntington Beach

Research Site, Huntington Beach, California, United States, 92647

La Mesa

Research Site, La Mesa, California, United States, 91942

Newport Beach

Research Site, Newport Beach, California, United States, 92663

San Jose

Research Site, San Jose, California, United States, 95117

Wilmington

Research Site, Wilmington, Delaware, United States, 19805

Cutler Bay

Research Site, Cutler Bay, Florida, United States, 33189

Hialeah

Research Site, Hialeah, Florida, United States, 33012

Leesburg

Research Site, Leesburg, Florida, United States, 34748

Miami

Research Site, Miami, Florida, United States, 33155

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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:
  • 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.
  • 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.

Ages Eligible for Study

18 Years to 75 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AstraZeneca,

Study Record Dates

2028-04-03