Tozorakimab for Asthma

(Umbriel Trial)

Recruiting at 145 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: AstraZeneca

Must be taking: Inhaled corticosteroids, LABA

Disqualifiers: Pulmonary disease, Smoking, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 26 weeks

540 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but it requires participants to be on medium-to-high dose inhaled corticosteroids with a LABA (long-acting beta-agonist).

What data supports the effectiveness of the drug Tozorakimab for asthma?

While there is no direct data on Tozorakimab for asthma, similar treatments like tezepelumab, a monoclonal antibody, have shown significant reductions in asthma exacerbations and improved asthma control. This suggests that monoclonal antibodies targeting specific inflammatory pathways can be effective in managing severe asthma. ^{1 2 3 4 5}

Eligibility Criteria

Adults aged 18-75 with uncontrolled asthma, despite using medium-to-high dose inhaled corticosteroids, can join this trial. They must have a history of asthma for at least 12 months and show signs of frequent exacerbations. Women must test negative for pregnancy and all participants should agree to use contraception.

Inclusion Criteria

Provision of signed and dated written informed consent prior to any study-specific procedures

Demonstration of uncontrolled asthma through ACQ-6 score ≥ 1.5

Participants need to demonstrate a ≥70% compliance for Asthma Daily Diary

Exclusion Criteria

Unstable cardiovascular disorders

I do not have active tuberculosis, hepatitis, HIV, or any current cancer or immune disease.

I finished antibiotics for a lung infection within the last 4 weeks.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous doses of tozorakimab or placebo

26 weeks

Regular visits for dosing and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

26 weeks

Treatment Details

Interventions

• Tozorakimab

Trial Overview The study is testing the effectiveness and safety of Tozorakimab compared to a placebo in adults with uncontrolled asthma. It's a phase IIb trial where patients are randomly assigned to receive either Tozorakimab or a placebo alongside their regular asthma medication.

Participant Groups

Group I: Tozorakimab Dose 2 Experimental Treatment 1 Intervention

Dosing subcutaneously tozorakimab Dose 2 and placebo

Group II: Tozorakimab Dose 1 Experimental Treatment 1 Intervention

Dosing subcutaneously tozorakimab Dose 1

Group III: Placebo Placebo Group 1 Intervention

Dosing subcutaneously with equivalent volume to tozorakimab

Who Is Running the Clinical Trial?

AstraZeneca

Lead Sponsor

Trials

4,491

Recruited

290,540,000+

Sir Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Dr. Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Pascal Soriot

AstraZeneca

Chief Executive Officer since 2012

Veterinary Medicine from École nationale vétérinaire d'Alfort, MBA from HEC Paris

Cristian Massacesi

AstraZeneca

Chief Medical Officer since 2021

MD from Marche Polytechnic University, Medical Oncology training at Royal Marsden Hospital, Kaplan Comprehensive Cancer Center, and European Institute of Oncology

Findings from Research

In a phase IV study of patients with severe refractory T2-high asthma treated with mepolizumab, significant improvements in asthma control and lung function were observed after 12 months, with a 71.22% reduction in asthma exacerbations.

Mepolizumab was found to be safe, with only 3.27% of patients discontinuing treatment due to musculoskeletal disorders, indicating its potential as an effective add-on therapy for this asthma phenotype.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-Life Performance of Mepolizumab in T2-High Severe Refractory Asthma with the Overlapping Eosinophilic-Allergic Phenotype. González-Pérez, R., Poza-Guedes, P., Mederos-Luis, E., et al.[2023]

Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, significantly reduced asthma exacerbations by up to 71% in adults with severe, uncontrolled asthma, as shown in the previous PATHWAY phase 2b study.

The ongoing NAVIGATOR phase 3 study, involving 1061 participants, aims to evaluate tezepelumab's efficacy in reducing exacerbations and improving lung function and quality of life across various asthma phenotypes, including those with low eosinophil counts.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. Menzies-Gow, A., Colice, G., Griffiths, JM., et al.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Real-Life Performance of Mepolizumab in T2-High Severe Refractory Asthma with the Overlapping Eosinophilic-Allergic Phenotype. [2023]

2. England pubmed.ncbi.nlm.nih.gov

NAVIGATOR: a phase 3 multicentre, randomized, double-blind, placebo-controlled, parallel-group trial to evaluate the efficacy and safety of tezepelumab in adults and adolescents with severe, uncontrolled asthma. [2021]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Monoclonal antibodies in the management of asthma: Dead ends, current status and future perspectives. [2023]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Impact of Anti-IL5 Therapies on Patients with Severe Uncontrolled Asthma and Possible Predictive Biomarkers of Response: A Real-Life Study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Evaluation of real-world mepolizumab use in severe asthma across Europe: the SHARP experience with privacy-preserving federated analysis. [2023]