Tezepelumab for COPD

(JOURNEY Trial)

Recruiting at 151 trial locations

Overseen By AstraZeneca Clinical Study Information Center

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Recruiting

Sponsor: AstraZeneca

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 3 Study to Evaluate the Efficacy and Safety of Tezepelumab in Adults with Moderate to Very Severe Chronic Obstructive Pulmonary Disease (COPD)

Research Team

MeiLan Han, MD

Principal Investigator

University of Michigan Health, Pulmonary & Critical Care Medicine,

Eligibility Criteria

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.

Treatment Details

Interventions

• Tezepelumab (Monoclonal Antibodies)

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.

Participant Groups

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