Tezepelumab for Asthma

(SUNRISE Trial)

Recruiting at 63 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: Oral corticosteroids, LABA, ICS

Must not be taking: SABA, Biologics

Disqualifiers: Pulmonary disease, Cancer, Smoking, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 40

Duration: 28 weeks

125 Participants Needed

Trial Summary

What is the purpose of this trial?

A Randomised, Double-Blind, Parallel-Group, Placebo-Controlled 28-week Phase 3 Efficacy and Safety Study of Tezepelumab in Reducing Oral Corticosteroid Use in Adults with Oral Corticosteroid Dependent Asthma

Do I have to stop taking my current medications for the trial?

The trial does not specify that you must stop taking your current medications. In fact, you must continue taking your oral corticosteroids (OCS) and other asthma medications as prescribed. There is no specific washout or taper-off period mentioned for other medications.

What data supports the idea that the drug Tezepelumab for Asthma is an effective treatment?

The available research shows that Tezepelumab is effective for treating severe, uncontrolled asthma. In studies, patients who took Tezepelumab had better lung function, with an improvement in how much air they could breathe out in one second. They also had fewer asthma attacks compared to those who took a placebo, which is a fake treatment. Additionally, Tezepelumab was found to be safe, as it did not cause more side effects than the placebo. These results suggest that Tezepelumab can help people with severe asthma breathe better and have fewer asthma problems. ^{1 2 3 4 5}

What safety data is available for Tezepelumab in treating asthma?

Tezepelumab has been evaluated in several clinical trials, including the PATHWAY and NAVIGATOR studies. The safety data from these trials indicate that the incidence of adverse events in patients treated with Tezepelumab was similar to those receiving a placebo. A systematic review and meta-analysis of six randomized controlled trials involving 2667 patients showed that Tezepelumab did not result in a higher incidence of adverse drug reactions compared to placebo. Overall, Tezepelumab has an acceptable safety profile for patients with severe, uncontrolled asthma. ^{1 2 5 6 7}

Is the drug Tezepelumab a promising treatment for asthma?

Yes, Tezepelumab is a promising drug for treating asthma. It has been shown to significantly reduce asthma attacks and improve lung function in people with severe, uncontrolled asthma. It works by blocking a key step in the body's process that leads to airway inflammation, making it easier for patients to breathe. The drug has been approved in several countries and has a good safety profile. ^{1 5 7 8 9}

Eligibility Criteria

Adults aged 18-80 with asthma dependent on oral corticosteroids (OCS) for at least 6 months, currently taking a stable OCS dose, and have had an asthma exacerbation in the past two years. Participants must not be current heavy smokers or recent users of certain medications and should not have significant other health issues that could interfere with the trial.

Inclusion Criteria

I have been on a medium or high dose of prescribed inhaler steroids for over a year.

I have been using additional asthma control medications for at least 3 months.

I have been on prescribed LABA and high dose ICS for at least 3 months.

Exclusion Criteria

I am a current smoker or have a history of heavy smoking, or I use vaping products.

I've needed more asthma medication or steroids in the last 30 days.

I have been treated for tuberculosis within the last year.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive tezepelumab or placebo via subcutaneous injection over a 28-week period

28 weeks

Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Follow-up visit at Week 40

Treatment Details

Interventions

• Placebo
• Tezepelumab

Trial Overview The study is testing Tezepelumab's effectiveness in reducing the need for oral steroids compared to a placebo over 28 weeks. This phase 3 trial randomly assigns participants to either receive Tezepelumab or a placebo while keeping both doctors and patients unaware of who receives which treatment.

Participant Groups

Group I: Tezepelumab Experimental Treatment 1 Intervention

Tezepelumab subcutaneous injection, in an accessorised pre-filled syringe.

Group II: Placebo Placebo Group 1 Intervention

Placebo subcutaneous injection, in an accessorised pre-filled syringe.

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

Amgen

Industry Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

Robert A. Bradway

Amgen

Chief Executive Officer since 2012

MBA from Harvard Business School

Paul Burton

Amgen

Chief Medical Officer since 2023

MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London

Findings from Research

Tezepelumab, a monoclonal antibody approved for severe uncontrolled asthma, significantly improved forced expiratory volume (FEV1) by 0.15 L and reduced asthma exacerbation rates by 0.60 per year compared to placebo, based on a meta-analysis of six trials with 2667 patients.

The treatment was found to have an acceptable safety profile, with no higher incidence of adverse drug reactions compared to placebo, indicating it is a safe option for patients with severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab for Patients with Severe Uncontrolled Asthma: A Systematic Review and Meta-Analysis. Zoumot, Z., Al Busaidi, N., Tashkandi, W., et al.[2022]

In the phase 3 NAVIGATOR study involving patients aged 12-80 with severe asthma, tezepelumab significantly improved various lung function parameters, including pre-bronchodilator FEV1 and forced vital capacity (FVC), compared to placebo over 52 weeks.

Improvements in lung function were observed as early as 1-2 weeks and were particularly pronounced in patients with a shorter disease duration and specific baseline lung function characteristics, indicating tezepelumab's efficacy in managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Menzies-Gow, A., Ambrose, CS., Colice, G., et al.[2023]

In a study involving 550 adults with severe, uncontrolled asthma, tezepelumab significantly reduced annualized asthma exacerbation rates by 55-83% compared to placebo, demonstrating its efficacy in managing severe asthma.

Tezepelumab also lowered levels of various type 2 inflammatory biomarkers, indicating a reduction in airway inflammation, regardless of the patients' baseline biomarker profiles.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Baseline type 2 biomarker levels and response to tezepelumab in severe asthma. Corren, J., Pham, TH., Garcia Gil, E., et al.[2022]

Tezepelumab significantly reduced airway eosinophil counts in patients with uncontrolled asthma, indicating its efficacy in lowering eosinophilic airway inflammation, which is a key factor in asthma exacerbations.

The treatment also improved airway hyperresponsiveness to mannitol, suggesting that blocking TSLP may provide additional benefits in asthma management beyond just reducing type 2 inflammation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. Diver, S., Khalfaoui, L., Emson, C., et al.[2022]

Tezepelumab significantly reduced the number of severe asthma attacks and improved lung function in participants compared to placebo, demonstrating its efficacy in treating severe, uncontrolled asthma.

The treatment was well-tolerated, with similar rates of health issues between the tezepelumab and placebo groups, indicating a favorable safety profile for this biologic therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies. Corren, J., Menzies-Gow, A., Bimmel, J., et al.[2023]

Tezepelumab significantly reduced asthma exacerbations by 60% compared to placebo in a pooled analysis of 1,334 patients from two major trials, demonstrating its efficacy across various subgroups of severe, uncontrolled asthma.

The treatment not only lowered the rate of exacerbations but also decreased related hospitalizations and emergency visits, with a similar safety profile to placebo, indicating it is a safe and effective option for managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Corren, J., Menzies-Gow, A., Chupp, G., et al.[2023]

In a phase 2 trial involving 436 patients with uncontrolled moderate-to-severe asthma, tezepelumab significantly reduced the annualized rate of asthma exacerbations by 61% to 71% compared to placebo, demonstrating its efficacy in managing asthma symptoms.

Tezepelumab also improved lung function, as indicated by higher forced expiratory volume in 1 second (FEV1) across all dosing groups, with minimal adverse events leading to discontinuation, suggesting a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab in Adults with Uncontrolled Asthma. Corren, J., Parnes, JR., Wang, L., et al.[2022]

Tezepelumab significantly reduced annualized asthma exacerbation rates (AAER) by 66% to 78% in patients with perennial allergy and by 67% to 71% in those without, based on a study of 550 adults over 52 weeks.

The treatment also improved lung function (measured by prebronchodilator FEV1) and reduced type 2 biomarkers, demonstrating its efficacy in managing severe, uncontrolled asthma regardless of allergy status.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy. Corren, J., Ambrose, CS., Sałapa, K., et al.[2021]

Tezepelumab, a monoclonal antibody targeting thymic stromal lymphopoietin, demonstrated linear pharmacokinetics and a long half-life of 19.9 to 25.7 days, indicating effective dosing intervals for asthma treatment.

The drug was well tolerated in phase I studies with no signs of immunogenicity, suggesting it is safe for use in healthy individuals and those with atopic dermatitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Tezepelumab (AMG 157) in Healthy and Atopic Dermatitis Adult Subjects. Parnes, JR., Sullivan, JT., Chen, L., et al.[2022]

References

1. New Zealand pubmed.ncbi.nlm.nih.gov

Tezepelumab for Patients with Severe Uncontrolled Asthma: A Systematic Review and Meta-Analysis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. [2023]

3. Denmark pubmed.ncbi.nlm.nih.gov

Baseline type 2 biomarker levels and response to tezepelumab in severe asthma. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Effect of tezepelumab on airway inflammatory cells, remodelling, and hyperresponsiveness in patients with moderate-to-severe uncontrolled asthma (CASCADE): a double-blind, randomised, placebo-controlled, phase 2 trial. [2022]

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

Tezepelumab for the treatment of severe asthma: a plain language summary of the PATHWAY and NAVIGATOR studies. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Tezepelumab in Adults with Uncontrolled Asthma. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy of Tezepelumab in Patients with Severe, Uncontrolled Asthma and Perennial Allergy. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Safety, and Tolerability of Tezepelumab (AMG 157) in Healthy and Atopic Dermatitis Adult Subjects. [2022]