RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-03-26
Study Completion:2028-04-03
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06932263

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.

Ages Eligible for Study:18 Years to 75 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Provision of signed and dated written informed consent prior to any study-specific procedures.
  2. 2. Adults aged 18-75, inclusive when signing the informed consent.
  3. 3. Documented physician-diagnosis of asthma for at least 12 months.
  4. 4. Treated with medium or high dose ICS in combination with LABA.
  5. 5. Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
  6. 6. Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
  7. 7. Documented exacerbation history in the last 12 months and biomarker requirements of:
  8. 1. 2 severe exacerbations OR
  9. 2. 1 severe exacerbation and:
  10. 8. Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
  11. 9. Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
  12. 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. 1. Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
  2. 2. Clinically significant pulmonary disease other than asthma .
  3. 3. Current smokers, former smokers with \>10 pack-years history.
  4. 4. Clinically significant aortic stenosis or pulmonary arterial hypertension.
  5. 5. Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
  6. 6. Unstable cardiovascular disorders.

Contacts and Locations

Study Contact

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

Study Locations (Sites)

Research Site
Bakersfield, California, 93301
United States
Research Site
Huntington Beach, California, 92647
United States
Research Site
La Mesa, California, 91942
United States
Research Site
Newport Beach, California, 92663
United States
Research Site
San Jose, California, 95117
United States
Research Site
Wilmington, Delaware, 19805
United States
Research Site
Cutler Bay, Florida, 33189
United States
Research Site
Hialeah, Florida, 33012
United States
Research Site
Leesburg, Florida, 34748
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Miami, Florida, 33155
United States
Research Site
Miami, Florida, 33175
United States
Research Site
Miami, Florida, 33197
United States
Research Site
Orlando, Florida, 32819
United States
Research Site
Palmetto Bay, Florida, 33157
United States
Research Site
Tampa, Florida, 33607
United States
Research Site
Winter Park, Florida, 32789
United States
Research Site
Boise, Idaho, 83706
United States
Research Site
Indianapolis, Indiana, 46268
United States
Research Site
West Des Moines, Iowa, 50266
United States
Research Site
Louisville, Kentucky, 40218
United States
Research Site
White Marsh, Maryland, 21162
United States
Research Site
Farmington Hills, Michigan, 48336
United States
Research Site
Warren, Michigan, 48088
United States
Research Site
Saint Louis, Missouri, 63141
United States
Research Site
Bellevue, Nebraska, 68123
United States
Research Site
Grand Island, Nebraska, 68803
United States
Research Site
Omaha, Nebraska, 68134
United States
Research Site
Toms River, New Jersey, 08755
United States
Research Site
Maspeth, New York, 11378
United States
Research Site
Asheville, North Carolina, 28803
United States
Research Site
Huntersville, North Carolina, 28078
United States
Research Site
Kings Mountain, North Carolina, 28086
United States
Research Site
Toledo, Ohio, 43617
United States
Research Site
Edmond, Oklahoma, 73034
United States
Research Site
Grants Pass, Oregon, 97527
United States
Research Site
Medford, Oregon, 97504
United States
Research Site
Portland, Oregon, 97202
United States
Research Site
DuBois, Pennsylvania, 15801
United States
Research Site
Philadelphia, Pennsylvania, 19140
United States
Research Site
Smithfield, Pennsylvania, 15478
United States
Research Site
Rock Hill, South Carolina, 29732
United States
Research Site
Knoxville, Tennessee, 37919
United States
Research Site
Austin, Texas, 78759
United States
Research Site
Forney, Texas, 75126
United States
Research Site
Kingwood, Texas, 77339
United States
Research Site
Tyler, Texas, 75708
United States
Research Site
Victoria, Texas, 77901
United States
Research Site
Bellingham, Washington, 98225
United States
Research Site
Kingwood, West Virginia, 26537
United States
Research Site
Milwaukee, Wisconsin, 53228
United States

Collaborators and Investigators

Sponsor: AstraZeneca

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-26
Study Completion Date2028-04-03

Study Record Updates

Study Start Date2025-03-26
Study Completion Date2028-04-03

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma