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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
540
The drug will be administered subcutaneously.
Placebo will be administered subcutaneously.
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.
Time frame: Over 26 to 52 weeks
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.
Time frame: Over 26 to 52 weeks
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.
Time frame: Over 26 to 52 weeks
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1)
Difference in mean change from baseline between tozorakimab and placebo.
Time frame: Over weeks 20 to 26
Change from baseline in post-bronchodilator FEV1
Difference in mean change from baseline between tozorakimab and placebo.
Time frame: At week 26
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.
Time frame: At week 26
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Research Site
Bakersfield, California, United States
RECRUITINGResearch Site
Huntington Beach, California, United States
WITHDRAWNResearch Site
La Mesa, California, United States
TERMINATEDResearch Site
Loma Linda, California, United States
WITHDRAWNResearch Site
Long Beach, California, United States
WITHDRAWNResearch Site
Newport Beach, California, United States
RECRUITINGResearch Site
San Jose, California, United States
RECRUITINGResearch Site
Wilmington, Delaware, United States
TERMINATEDResearch Site
Cutler Bay, Florida, United States
SUSPENDEDResearch Site
Hialeah, Florida, United States
SUSPENDED...and 212 more locations
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.
Time frame: At week 26
Trough serum concentrations of tozorakimab
Pharmacokinetics: concentrations of tozorakimab in trough serum.
Time frame: Over 52 weeks
Anti-drug antibody incidence
Immunogenicity: Number of Participants With Positive Antibodies to tozorakimab
Time frame: Over 52 weeks