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Tests treatment safety and results for Asthma
Official title Dose Range Finding Study to Assess Efficacy and Safety of Tozorakimab in Adults With Uncontrolled Asthma on Medium-to-High Dose Inhaled Corticosteroids
ClinicalTrials.gov ID: NCT06932263
What this study is testing
What is Tozorakimab?
Tozorakimab is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for asthma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75
You may be able to join if
- Provision of signed and dated written informed consent prior to any study-specific procedures.
- Adults aged 18-75, inclusive when signing the informed consent.
- Documented physician-diagnosis of asthma for at least 12 months.
- Treated with medium or high dose ICS in combination with LABA.
- Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
You likely can't join if
- Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
- Clinically significant pulmonary disease other than asthma .
- Current smokers, former smokers with \>10 pack-years history.
- Clinically significant aortic stenosis or pulmonary arterial hypertension.
- Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
- Unstable cardiovascular disorders.
See the full eligibility criteria
- Provision of signed and dated written informed consent prior to any study-specific procedures.
- Adults aged 18-75, inclusive when signing the informed consent.
- Documented physician-diagnosis of asthma for at least 12 months.
- Treated with medium or high dose ICS in combination with LABA.
- Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
- Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
- Documented exacerbation history in the last 12 months and biomarker requirements of:
- 2 severe exacerbations OR
- 1 severe exacerbation and: (i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb
- Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
- Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
- Contraceptive use by males and females should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
- Clinically significant pulmonary disease other than asthma .
- Current smokers, former smokers with \>10 pack-years history.
- Clinically significant aortic stenosis or pulmonary arterial hypertension.
- Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
- Unstable cardiovascular disorders.
The study team makes the final eligibility decision.
Where it's taking place
- Bakersfield, California, United States
- Huntington Beach, California, United States
- La Mesa, California, United States
- Loma Linda, California, United States
- Long Beach, California, United States
- Newport Beach, California, United States
- San Jose, California, United States
- Wilmington, Delaware, United States
- Cutler Bay, Florida, United States
- Hialeah, Florida, United States
- Leesburg, Florida, United States
- Miami, Florida, United States
- Miami Lakes, Florida, United States
- Orlando, Florida, United States
- Palmetto Bay, Florida, United States
- Tampa, Florida, United States
- Winter Park, Florida, United States
- Boise, Idaho, United States
- Noblesville, Indiana, United States
- West Des Moines, Iowa, United States
+ 170 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bakersfield, California, United States; Huntington Beach, California, United States; La Mesa, California, United States; Loma Linda, California, United States; Long Beach, California, United States; Newport Beach, California, United States and 184 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.