Tezepelumab for Asthma

(SUNRISE Trial)

No longer recruiting at 79 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how tezepelumab, an experimental drug, can assist people with asthma who regularly use oral corticosteroids. The goal is to determine if this new treatment can reduce the need for these steroids, which often cause side effects. The trial targets individuals who have managed asthma for over a year and rely on daily oral corticosteroids. Participants will receive either the new treatment or a placebo via injection. This trial offers an opportunity to explore a new method for managing asthma symptoms and potentially reduce reliance on existing medications. As a Phase 3 trial, it represents the final step before FDA approval, allowing participants to contribute to the development of a promising new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that tezepelumab is generally safe for people with severe asthma. In previous studies, most participants taking tezepelumab did not experience serious side effects. The most common side effects were mild, such as headaches or sore throats. These studies included many participants, providing a clearer understanding of what to expect.

The FDA has already approved tezepelumab for treating severe asthma in other situations, indicating that its safety is well-understood. While no treatment is without risk, current data indicate that tezepelumab is considered safe. Always consult a healthcare provider to determine if joining a trial is the right choice. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Tezepelumab is unique because it targets a specific part of the immune system called thymic stromal lymphopoietin (TSLP), which plays a key role in the inflammation associated with asthma. Unlike standard treatments like inhaled corticosteroids and leukotriene modifiers that broadly suppress inflammation, Tezepelumab precisely blocks TSLP, potentially reducing asthma symptoms more effectively and with fewer side effects. Researchers are excited about Tezepelumab because it offers a novel approach that could benefit patients who do not respond well to existing therapies.

What evidence suggests that Tezepelumab might be an effective treatment for asthma?

Research has shown that tezepelumab, which participants in this trial may receive, can help reduce asthma flare-ups in people with severe, uncontrolled asthma. Studies have found that it significantly lowers the rate of asthma attacks compared to a placebo. In a large group of patients, it reduced the yearly rate of asthma attacks by 60%. This suggests that tezepelumab might assist those who need oral corticosteroids to manage their asthma symptoms. By targeting specific immune responses, it may ease breathing and reduce the need for other asthma medications. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

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]

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 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]

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]

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]

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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/37015033/

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma Tezepelumab reduced exacerbations in patients with severe, uncontrolled asthma across a range of baseline blood eosinophil counts and fractional exhaled nitric ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1704064

Tezepelumab in Adults with Uncontrolled Asthma Treatment with tezepelumab resulted in significantly lower annualized rates of asthma exacerbations than the rate with placebo among patients ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05329194

Study Details | NCT05329194 | Effectiveness and Safety ... This is a multicenter, single-arm, open-label, Post-authorization, Phase 4 study to assess the effectiveness of tezepelumab in the United States (US)

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10870843/

Is Efficacy of Tezepelumab Independent of Severe Asthma ... In the pooled population (1,334 patients), tezepelumab reduced AAER by 60% compared with placebo. In subgroups defined by baseline type 2 biomarkers, reductions ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S1323893022001319

Current summary of clinical studies on anti-TSLP antibody, ... Taken together, the results of these clinical trials have demonstrated that tezepelumab improved AAER in poorly controlled patients with asthma who had at ...

6. amgen.com amgen.com/stories/2021/12/-/media/Themes/Global/Global/Global/images/migration/stories/2021/12-17-Severe-Asthma-and-TSLP---Fast-Facts/Tezspire-PDUFA-Discovery-Infographic.pdf

(tezepelumab-ekko) This trial tested the efficacy and safety of Tezspire™ in adults and adolescents with severe asthma. When added to SOC† patients who received Tezspire™ (n=529).

7. tezspirehcp.com tezspirehcp.com/severe-asthma/clinical-data/additional-data

TEZSPIRE® (tezepelumab-ekko) for Severe Asthma | For HCPs Look at more TEZSPIRE clinical data related to reductions in exacerbations, and improvements in lung function and overall quality of life.