Tezepelumab for COPD

(JOURNEY Trial)

Recruiting at 242 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 an experimental medication called Tezepelumab to determine its effectiveness for people with Chronic Obstructive Pulmonary Disease (COPD), a condition that makes breathing difficult. The trial compares two different doses of Tezepelumab against a placebo (a substance with no active drug) to evaluate its effectiveness and safety. It seeks participants who have had COPD for at least a year, regularly use inhalers, and have experienced recent flare-ups requiring treatment. Participants should also be former or current smokers with a history of smoking at least 10 pack-years. The goal is to determine if Tezepelumab can reduce symptoms and improve the quality of life for people with moderate to very severe COPD. 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 certain therapies like macrolides and systemic immuno-suppressive or -modulating medications are noted. It's best to discuss your specific medications with the trial team.

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

Research has shown that tezepelumab is generally well-tolerated in individuals with moderate to very severe COPD. Most side effects in these studies were mild to moderate, with some participants experiencing headaches, sore throats, or cold-like symptoms.

Serious side effects were rare. The studies found these issues did not differ significantly from those seen with a placebo (a harmless, inactive substance). This suggests that tezepelumab might be a safe option for those considering participation in a clinical trial for COPD treatment. ^{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 part of the immune system called thymic stromal lymphopoietin (TSLP). Unlike current COPD treatments, which mainly focus on alleviating symptoms or reducing inflammation, Tezepelumab aims to address the underlying immune response that contributes to the disease. This approach could offer a new way to manage COPD, potentially reducing flare-ups and improving lung function more effectively. Researchers are excited because this could mean better control of the condition with fewer side effects compared to traditional treatments.

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

Research has shown that tezepelumab might help people with chronic obstructive pulmonary disease (COPD). One study found that participants taking tezepelumab experienced 17% fewer COPD flare-ups annually. These flare-ups can make breathing more difficult, so reducing them might improve breathing. However, another study did not find a significant reduction in flare-ups with tezepelumab. While results are mixed, this trial will explore different doses of tezepelumab to evaluate its effectiveness for COPD. ^{1 2 6 7 8}

Who Is on the Research Team?

MeiLan Han, MD

Principal Investigator

University of Michigan Health, Pulmonary & Critical Care Medicine,

Are You a Good Fit for This Trial?

This trial is for adults with moderate to very severe COPD, a lung condition that makes it hard to breathe. Participants should meet specific health criteria but the provided information doesn't detail these requirements.

Inclusion Criteria

I am between 40 and 80 years old.

Eosinophils (EOS) count of at least 150 cells/μL during screening

COPD Assessment Test (CAT) score of at least 15 at screening

Exclusion Criteria

Presence of any unstable disorder that can impact participant safety or study outcomes

I have or had cancer before.

I have not been on macrolides or immune-modifying drugs for over 6 months.

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

Monthly visits for injections

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 is testing Tezepelumab's effectiveness and safety against a placebo in improving COPD symptoms. It's a phase 3 trial, meaning it's late-stage research involving many participants to confirm results 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 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, 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]

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 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]

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]

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 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]

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