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Monoclonal Antibodies

Tezepelumab for Asthma (ARRIVAL Trial)

Phase 3

Recruiting

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

2. Patients must be 12 to 80 years of age inclusive, at the time of signing the ICF.

6. History of physician-diagnosed asthma that requires continuous treatment with high-dose ICS (as defined by GINA or highest approved dose per posology per country) plus a LABA for at least 6 months prior to Visit 1 (Appendix I). The ICS and LABA can be contained within a combination product or given by separate inhalers.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 56 and week 72

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial aims to see if patients with severe asthma who are treated with tezepelumab can reduce their medication while still maintaining control over their asthma symptoms. The study will last up to

Who is the study for?

This trial is for people aged 12-80 with severe asthma, who've been on high-dose inhalers plus long-acting bronchodilators for at least 6 months. They should have a history of asthma documented for over a year and show certain levels of lung function variability or reversibility.

What is being tested?

The study tests if tezepelumab can help patients reduce their regular asthma medications without losing control over their symptoms. It involves subcutaneous injections, lasts up to 72 weeks, with visits every four weeks.

What are the potential side effects?

Potential side effects may include reactions at the injection site, headache, fatigue, and possible worsening of asthma symptoms. Each patient's experience may vary.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 80 years old.

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I have asthma and have been on high-dose inhalers plus a long-acting bronchodilator for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 56 and week 72

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 56 and week 72

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 56 and week 72 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Proportion of patients who reduced their SYMBICORT® daily maintenance dose without the loss of asthma control at the end of the step-down phase.

Secondary study objectives

AAER between Week 0 and Week 24 among all tezepelumab-treated patients

AAER between Week 24 and Week 56

AAER between Week 24 and Week 72

+38 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group 3 - No Asthma Control or Low Biomarkers - No Step-down of ICSExperimental Treatment4 Interventions

No Asthma Control or Low Biomarkers - No Step-down of ICS

Group II: Group 2 - Asthma Control or Low Biomarkers - No Step-down of ICSExperimental Treatment5 Interventions

Asthma Control or Low Biomarkers - No Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2

Group III: Group 1 - Asthma Control or Low Biomarkers - Step-down of ICSExperimental Treatment5 Interventions

Asthma Control or Low Biomarkers - Step-down of ICS. Only patients with asthma control or low biomarkers at Week 24 will be randomized into Group 1 or 2

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mannitol

2019

Completed Phase 4

~2900

Salbutamol

1998

Completed Phase 4

~3910