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

Résumé

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.

Éligibilité

Conception de l'étude

Critères de jugement

1. Critère de jugement principal

   Annualised rate of severe asthma exacerbations

   The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and ≥ 1 severe exacerbation within 12 months prior to screening.

   Délai Over 26 to 52 weeks

2. Critère de jugement secondaire

   Annualised rate of severe asthma exacerbations

   The rate ratio of severe asthma exacerbations will be assessed in the participants with uncontrolled moderate-to-severe asthma and baseline eosinophils \< 300 cells/µL and history of ≥2 severe exacerbations within 12 months prior to screening.

   Délai Over 26 to 52 weeks

3. Critère de jugement secondaire

   Time to first severe asthma exacerbation

   To evaluate the effect of two dose levels of tozorakimab compared to placebo on time to first severe asthma exacerbations.

   Délai Over 26 to 52 weeks

4. Critère de jugement secondaire

   Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)

   Difference in mean change from baseline between tozorakimab and placebo.

   Délai Over weeks 20 to 26

5. Critère de jugement secondaire

   Change from baseline in post-bronchodilator FEV1

   Difference in mean change from baseline between tozorakimab and placebo.

   Délai At week 26

6. Critère de jugement secondaire

   Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6)

   Difference in mean change from baseline between tozorakimab and placebo. The ACQ-6 has 6 questions (regarding asthma symptoms and rescue bronchodilator use). Answering the questions results in a score out of 6. A Score of 0 indicates complete control and 6 reflects severely uncontrolled disease.

   Délai At week 26

7. Critère de jugement secondaire

   Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+)

   Difference in mean change from baseline between tozorakimab and placebo. The AQLQ12+ includes 32 questions grouped into four domains: symptoms; activity limitations; emotional function; and, environmental stimuli. Each question is scored on a seven-point Likert scale, which ranges from 7 (no impairment) to 1 (severe impairment). The overall score is calculated as the mean of all questions, and the four domain scores are the means of the scores for the questions in the respective domains.

   Délai At week 26

8. Critère de jugement secondaire

   Trough serum concentrations of tozorakimab

   Pharmacokinetics: concentrations of tozorakimab in trough serum.

   Délai Over 52 weeks

9. Critère de jugement secondaire

   Anti-drug antibody incidence

   Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab

   Délai Over 52 weeks

Dates

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Lieux

150 sites sont en recrutement

171 sites supplémentaires sont indiqués dans la fiche du registre.

Documents de l'étude

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