Recruiting NCT06932263

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

Phase II Interventional Asthma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Tozorakimab, Placebo.
Who it may be relevant to: Registry conditions: Asthma. Basic parameters: 18 years — 75 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Brazil, Chile, China +16
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

Drug Tozorakimab
The drug will be administered subcutaneously.
Drug Placebo
Placebo will be administered subcutaneously.

Primary outcome measures

Annualised rate of severe asthma exacerbations [Time frame: Over 26 to 52 weeks]

Secondary outcome measures (8)

Annualised rate of severe asthma exacerbations [Time frame: Over 26 to 52 weeks]
Time to first severe asthma exacerbation [Time frame: Over 26 to 52 weeks]
Change from baseline in pre-bronchodilator forced expiratory volume in 1 second (FEV1) [Time frame: Over weeks 20 to 26]
Change from baseline in post-bronchodilator FEV1 [Time frame: At week 26]
Change from baseline in the Asthma Control Questionnaire 6 (ACQ-6) [Time frame: At week 26]
Change from baseline in the Asthma Quality of Life Questionnaire for 12 Years and Older (AQLQ12+) [Time frame: At week 26]
Trough serum concentrations of tozorakimab [Time frame: Over 52 weeks]
Anti-drug antibody incidence [Time frame: Over 52 weeks]

Eligibility criteria

Inclusion criteria

Provision of signed and dated written informed consent prior to any study-specific procedures.
Adults aged 18-75, inclusive when signing the informed consent.
Documented physician-diagnosis of asthma for at least 12 months.
Treated with medium or high dose ICS in combination with LABA.
Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5 .
Pre-bronchodilator FEV1 ≥ 40% to ≤ 90% of predicted normal.
Documented exacerbation history in the last 12 months and biomarker requirements of:

2 severe exacerbations OR
1 severe exacerbation and:

(i) Eosinophils ≥ 150 cells/µl or (ii) FeNo ≥ 25 ppb

Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary.
Women of Child Bearing Potential (WOCBP) must have a negative pregnancy test.
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

Completed treatment for respiratory infection with antibiotics in the 4 weeks prior to Visit 1.
Clinically significant pulmonary disease other than asthma .
Current smokers, former smokers with >10 pack-years history.
Clinically significant aortic stenosis or pulmonary arterial hypertension.
Active tuberculosis, hepatitis, HIV, or current diagnosis of cancer or immune complex disease.
Unstable cardiovascular disorders.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment