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

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About the study

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.
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Who can take part

You may be eligible to participate in the study if you meet the following criteria:

INCLUSION 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

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.
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Study Locations

Enter your ZIP code/Postal code/PIN code to locate study sites near you:

How to Apply


Contact the study center to learn if this study is a good match for you.
Phone iconCall 1-877-240-9479Email iconEmail Study Center

Study’s details


Contition
Asthma
Age
18 - 75
Phase
Phase 2
Participants needed
540
Est. Completion Date
Mar 16, 2028
Treatment type
Interventional

ClinicalTrials.gov identifier
NCT06932263
Study number
D9181C00002

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