Tezepelumab for COPD

(EMBARK Trial)

Recruiting at 275 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AstraZeneca

Must be taking: ICS, LABA, LAMA

Must not be taking: Macrolides, Immunosuppressives

Disqualifiers: Asthma, Tuberculosis, Malignancies, 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: Unknown

Duration: 52-76 weeks

990 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests Tezepelumab, a medication for individuals with moderate to very severe Chronic Obstructive Pulmonary Disease (COPD). The trial aims to evaluate how well Tezepelumab manages COPD symptoms and assess its safety. Participants will receive one of two doses of Tezepelumab or a placebo (a treatment with no active drug) to compare results. This trial suits those who have had COPD for at least a year, experience frequent flare-ups, and are former or current smokers with a history of at least 10 pack-years. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for COPD.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it mentions that participants should have been on certain inhaled COPD therapies for at least 3 months before starting. It also lists some medications that might not be allowed, like macrolides and certain immune system medications.

Is there any evidence suggesting that Tezepelumab is likely to be safe for humans?

Research has shown that tezepelumab is generally safe for people with moderate to very severe chronic obstructive pulmonary disease (COPD). Studies have found that most patients do not experience major side effects compared to those taking a placebo. If side effects occur, they are usually mild to moderate. Some patients might experience common side effects like a headache or sore throat, but these are not serious. Overall, current data indicates that the safety of tezepelumab is promising for managing COPD. ^{1 2 3 4 5}

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

Tezepelumab is unique because it targets a specific pathway in the immune system known as TSLP (thymic stromal lymphopoietin), which plays a key role in inflammation associated with COPD. Unlike the standard treatments for COPD, such as bronchodilators and inhaled corticosteroids that mainly focus on symptom relief, Tezepelumab aims to address the underlying inflammation. This new approach has the potential to provide more comprehensive disease management and improve outcomes for patients by reducing exacerbations and slowing disease progression. Researchers are excited about Tezepelumab because it represents a novel mechanism of action that could offer an effective alternative for those who do not respond well to current therapies.

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

Research has shown that tezepelumab might help reduce symptoms in people with moderate to very severe COPD. One study found that patients taking tezepelumab experienced 17% fewer COPD flare-ups compared to those taking a placebo. This trial will test different doses of tezepelumab to evaluate its effectiveness. However, other studies did not find a significant decrease in flare-ups, resulting in mixed outcomes. More research is needed to fully understand how well tezepelumab works for COPD. ^{1 2 3 6 7}

Who Is on the Research Team?

Dave Singh, MD

Principal Investigator

Division of Infection, Immunity & Resp Medicine, The University of Manchester, United Kingdom

Are You a Good Fit for This Trial?

This trial is for adults with moderate to very severe COPD, a chronic lung disease that obstructs airflow. Participants should meet specific health criteria but the provided information does not detail these requirements.

Inclusion Criteria

Eosinophils count ≥ 150 cells/μL during screening

CAT score ≥ 15 at screening

I have been diagnosed with COPD for over a year.

Exclusion Criteria

Any unstable disorder that can impact participant's safety or study outcomes

I have a lung condition that is not COPD.

I need more than 4 liters per minute of oxygen or my oxygen levels stay below 89% despite using oxygen.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive monthly subcutaneous injections of tezepelumab or placebo for a duration of 52 to 76 weeks

52-76 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Tezepelumab

Trial Overview The study tests Tezepelumab's effectiveness and safety against a placebo in improving COPD symptoms. It's a phase 3 trial, meaning it's at an advanced stage of testing with more participants to confirm its efficacy and monitor side effects.

How Is the Trial Designed?

Group I: Dose 2 of Tezepelumab Experimental Treatment 1 Intervention

Tezepelumab, SC, Q4W

Group II: Dose 1 of Tezepelumab Experimental Treatment 1 Intervention

Tezepelumab, SC, Q4W

Group III: Matching Placebo Placebo Group 1 Intervention

Matching placebo, SC, Q4W

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 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, 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 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]

In clinical trials, subcutaneous tezepelumab significantly reduced the annualized asthma exacerbation rate by up to 71% compared to placebo, demonstrating its efficacy in treating severe uncontrolled asthma.

Tezepelumab is effective across various asthma phenotypes, including nonallergic and noneosinophilic types, making it a versatile treatment option for patients with severe asthma regardless of their specific characteristics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab in the Treatment of Uncontrolled Severe Asthma. Feist, J., Lipari, M., Kale-Pradhan, P.[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]

Tezepelumab, a monoclonal antibody for severe asthma, demonstrated a lower incidence of adverse events and serious adverse events over 104 weeks compared to placebo, indicating a favorable safety profile.

The treatment significantly reduced asthma exacerbation rates by 58% in participants from the NAVIGATOR study and by 39% in those from the SOURCE study, showing sustained efficacy in managing severe, uncontrolled asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of tezepelumab in people with severe, uncontrolled asthma (DESTINATION): a randomised, placebo-controlled extension study. Menzies-Gow, A., Wechsler, ME., Brightling, CE., et al.[2023]

In a 52-week study involving 65 Japanese patients with severe uncontrolled asthma, tezepelumab was found to be safe and well-tolerated, with most adverse events being mild to moderate, and only one case leading to treatment discontinuation.

Tezepelumab significantly reduced asthma exacerbation rates (0.11 per patient-year) and improved lung function and asthma control, with a 71.4% responder rate at Week 52, indicating its efficacy in managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

One-year safety and tolerability of tezepelumab in Japanese patients with severe uncontrolled asthma: results of the NOZOMI study. Shinkai, M., Ebisawa, M., Fukushima, Y., 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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39653044/

Efficacy and safety of tezepelumab versus placebo in ... We aimed to assess the efficacy and safety of tezepelumab in patients with moderate to very severe COPD despite receiving triple inhaled therapy.

2. astrazeneca-us.com astrazeneca-us.com/media/press-releases/2024/new-data-presented-at-ats-2024-show-the-potential-of-tezspire-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease.html#!

New data presented at ATS 2024 show the potential of ... New data presented at ATS 2024 show the potential of TEZSPIRE to play a role in the future treatment of chronic obstructive pulmonary disease.

3. astrazeneca.com astrazeneca.com/content/astraz/media-centre/medical-releases/new-data-presented-at-ats-2024-show-the-potential-of-tezepelumab-to-play-a-role-in-the-future-treatment-of-chronic-obstructive-pulmonary-disease.html

New data presented at ATS 2024 show the potential of ... The primary results showed that treatment with AstraZeneca and Amgen's Tezspire (tezepelumab) led to a 17% numerical reduction in the annual ...

4. journal.chestnet.org journal.chestnet.org/article/S0012-3692(24)03624-9/fulltext

EFFICACY OF TEZEPELUMAB IN ADULTS WITH ... In the phase 2a COURSE study (NCT04039113), tezepelumab treatment did not significantly reduce the annualized rate of moderate or severe COPD exacerbations ...

5. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A4026

American Journal of Respiratory and Critical Care Medicine In the phase 2a, multicenter, double-blind COURSE study (NCT04039113), tezepelumab reduced the annualized rate of COPD exacerbations that were moderate ( ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06883305

NCT06883305 | A Study to Investigate the Efficacy and ... This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled, parallel group study to evaluate the safety and efficacy of tezepelumab in adults ...

7. jacionline.org jacionline.org/article/S0091-6749(25)00004-1/fulltext

Clarification of the efficacy of tezepelumab in the phase 2a ... Efficacy and safety of tezepelumab in adults with moderate to very severe chronic obstructive pulmonary disease: a randomised, placebo-controlled, phase 2a ...