Asthma study: Tozorakimab
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?
An investigational once‑daily injectable medicine being studied for uncontrolled 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
- The study will see if tozorakimab is safe and may help asthma symptoms when given under the skin, and it will compare it to a placebo.
- Who it's for
- Adults who have asthma that is not well controlled even with medium‑to‑high dose inhaled steroids.
- What's involved
- Participants will receive either tozorakimab or a placebo injection under the skin, and will have regular clinic visits and tests to monitor asthma control and safety.
- Time commitment
- The study lasts several months, with multiple clinic visits for injections, asthma assessments, and safety monitoring.
- 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.
- ≥ 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 is enrolling
- Bakersfield, California, United States
- Long Beach, California, United States
- Newport Beach, California, United States
- San Jose, California, United States
- Noblesville, Indiana, United States
- Hutchinson, Kansas, United States
- Louisville, Kentucky, United States
- Worcester, Massachusetts, United States
- Farmington Hills, Michigan, United States
- Grand Island, Nebraska, United States
- Omaha, Nebraska, United States
- Mullica Hill, New Jersey, United States
- Toms River, New Jersey, United States
- Horseheads, New York, United States
- Maspeth, New York, United States
- Kings Mountain, North Carolina, United States
- Toledo, Ohio, United States
- Medford, Oregon, United States
- Portland, Oregon, United States
- Philadelphia, Pennsylvania, United States
+ 111 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, but 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?
This study is enrolling now at Bakersfield, California, United States; Long Beach, California, United States; Newport Beach, California, United States; San Jose, California, United States; Noblesville, Indiana, United States; Hutchinson, Kansas, United States and 125 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.