What side effects are associated with this type of intervention?

Common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta-agonists (LABA), leukotriene modifiers, and monoclonal antibodies like Tezepelumab. ICS can cause side effects such as oral thrush, hoarseness, and coughing. LABAs may lead to headaches, muscle cramps, and increased heart rate. Leukotriene modifiers can cause headaches, abdominal pain, and mood changes. Monoclonal antibodies, including Tezepelumab, can cause injection site reactions, headaches, and an increased risk of infections. It is important to discuss these potential side effects with a healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several monoclonal antibodies for the treatment of asthma, focusing on reducing inflammation by targeting specific pathways. Notable examples include Mepolizumab and Reslizumab, which target interleukin-5 (IL-5) to reduce eosinophilic inflammation, and Omalizumab, which targets immunoglobulin E (IgE) to mitigate allergic responses. These treatments are similar to Tezepelumab, which targets thymic stromal lymphopoietin (TSLP) to reduce inflammation in severe asthma.

What other types of research exist?

Promising alternatives to Tezepelumab for asthma treatment include Omalizumab (Xolair), which has shown efficacy in peanut allergy and asthma, and Ligelizumab, which has been studied for severe asthma. Additionally, Quilizumab has been evaluated in allergic asthma, and anti-IL-33 therapies have shown potential in peanut allergy, which may translate to asthma treatment.

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Monoclonal Antibodies

Tezepelumab for Severe Asthma (WAYFINDER Trial)

Phase 3

Waitlist Available

Research Sponsored by AstraZeneca

Eligibility Criteria Checklist

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

Must have

Age 18-80 years.

Documented long-term OCS therapy for asthma, equivalent to a daily dose of at least 5 mg and up to 40 mg of prednisone/prednisolone for at least 3 continuous months directly preceding Visit 1.

Must not have

Pulmonary disease or systemic diseases, other than asthma associated with elevated peripheral EOS counts

History of cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 52

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing an injectable medication called Tezepelumab to help adults with severe asthma reduce their use of oral steroids. The medication works by reducing inflammation in the airways, which can make breathing easier. Tezepelumab has shown effectiveness in improving lung function in patients with severe, uncontrolled asthma.

Who is the study for?

Adults aged 18-80 with severe asthma, on long-term oral corticosteroids (5-40 mg of prednisone daily) for at least 3 months, and who've had an asthma exacerbation in the past year. Participants must have been on a stable steroid dose for 4 weeks prior to joining and treated with high-dose inhalers. Excluded are those with immunodeficiency, recent major surgery, other significant diseases or infections, drug abuse history within a year, previous tezepelumab use or participation in other trials.

What is being tested?

The trial is testing Tezepelumab's effectiveness and safety in reducing the need for oral steroids in adults with severe asthma. It aims to see if this treatment can help manage asthma better than current standard therapies.

What are the potential side effects?

Potential side effects of Tezepelumab may include reactions at the injection site, headaches, fatigue, and possible increased risk of infection due to its immune-modulating effects.

Eligibility Criteria

Inclusion Criteria

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

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I am between 18 and 80 years old.

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I have been on daily steroids for asthma, between 5 and 40 mg, for the last 3 months.

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I am between 18 and 80 years old.

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I have been on high-dose asthma medication for at least 6 months.

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I have been on a stable dose of oral corticosteroids for at least 4 weeks.

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I have had at least one asthma attack in the last year.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a lung or systemic disease, but it's not asthma with high EOS counts.

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I have had cancer in the past.

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I was diagnosed with a worm infection in the last 6 months that hasn't improved with standard treatment.

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I currently smoke or have a history of smoking equivalent to 10 pack-years or more, or I use vaping products.

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I have been treated for tuberculosis within the last year.

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I haven't had major surgery in the last 8 weeks nor plan to during the study.

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I am on long-term oral steroids for an inflammatory condition.

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I haven't taken immune-suppressing drugs in the last 12 weeks, except for asthma.

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I have tested positive for hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 52 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 participants who discontinued OCS without loss of asthma control

Proportion of participants who reduced daily prescribed maintenance OCS dose to ≤ 5 mg/day without loss of asthma control

Secondary study objectives

Absolute and percent change from baseline in daily maintenance OCS dose

Categorised percent reduction from baseline in the daily maintenance OCS dose

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

+10 more

Side effects data

From 2020 Phase 3 trial • 150 Patients • NCT03406078

16%

Nasopharyngitis

12%

Upper respiratory tract infection

Bronchitis bacterial

Asthma

Bronchitis

Oral candidiasis

Myalgia

Headache

Fall

Hypertension

Sinusitis

Cardiac arrest

Cardiac failure

Supraventricular tachycardia

Septic shock

Incisional hernia

Acute kidney injury

Inguinal hernia

Intervertebral discitis

Pneumonia

Arthralgia

Invasive breast carcinoma

Nephrolithiasis

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Tezepelumab

Placebo

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

1Treatment groups

Experimental Treatment

Group I: TezepelumabExperimental Treatment1 Intervention

Tezepelumab subcutaneous injection

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Tezepelumab

2018

Completed Phase 3

~2430

0 / 15Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta-agonists (LABAs), leukotriene modifiers, and monoclonal antibodies. ICS reduce inflammation by inhibiting multiple inflammatory pathways. LABAs relax airway muscles, improving airflow. Leukotriene modifiers block chemicals that cause inflammation and bronchoconstriction. Monoclonal antibodies, such as Tezepelumab, target specific molecules like thymic stromal lymphopoietin (TSLP) to reduce inflammation. This is crucial for asthma patients as it helps control symptoms, reduce exacerbations, and improve overall lung function, leading to better disease management and quality of life.

One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study.