Assessing the effects of tozorakimab in adults with uncontrolled asthma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase IIb clinical trial evaluates the efficacy and safety of tozorakimab, administered subcutaneously, in adults suffering from uncontrolled asthma while on medium-to-high doses of inhaled corticosteroids. The study is designed as a dose-range finding, double-blind, placebo-controlled trial, which means that participants will receive either the medication or a placebo without knowing which one they are receiving. The trial aims to determine the optimal dosage that provides the best outcomes for patients with asthma who have not achieved control with their current treatment. Participants will be monitored for their asthma control and any adverse effects throughout the study.

Why it matters

Who can join: the full rules

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.

Where it's running

• Research Site
  Bakersfield, California, United States Recruiting
• Research Site
  Long Beach, California, United States Recruiting
• Research Site
  Newport Beach, California, United States Recruiting
• Research Site
  San Jose, California, United States Recruiting
• Research Site
  Noblesville, Indiana, United States Recruiting
• Research Site
  Hutchinson, Kansas, United States Recruiting

+173 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: AstraZeneca Clinical Study Information Center
• Email: information.center@astrazeneca.com
• Phone: 1-877-240-9479

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.