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Assessing the effects of tozorakimab in adults with uncontrolled asthma

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

PHASE2 · AstraZeneca · NCT06932263

This study is testing a new asthma treatment called tozorakimab to see if it can help adults who still have asthma problems despite using their current medications.

Quick facts

PhasePHASE2
Study typeInterventional
Enrollment540 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorAstraZeneca (industry)
Drugs / interventionstozorakimab
Locations209 sites (Bakersfield, California and 208 other locations)
Trial IDNCT06932263 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-75 with a documented diagnosis of asthma who are currently experiencing uncontrolled symptoms despite using medium-to-high doses of inhaled corticosteroids.

Not a fit: Patients whose asthma is well-controlled with their current treatment regimen may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for patients with uncontrolled asthma.

How similar studies have performed: Previous studies have shown promise in similar approaches for treating uncontrolled asthma, indicating potential for success.

Eligibility criteria

Show full inclusion / exclusion criteria 
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 this trial is running

Bakersfield, California and 208 other locations

+159 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.

View on ClinicalTrials.gov →

Conditions: Asthma

Last reviewed 2026-05-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.