Mepolizumab for Chronic Obstructive Pulmonary Disease

(MATINEE Trial)

Recruiting at 302 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: GlaxoSmithKline

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

This is a multi-center, randomized, placebo-controlled, double-blind, parallel group study designed to confirm the benefits of mepolizumab treatment on moderate or severe exacerbations in chronic obstructive pulmonary disease (COPD) participants given as an add on to their optimized maintenance COPD therapy. The maximum duration of participant participation is approximately 109 weeks, consisting of 2 screening visits (up to 3 weeks), a run-in period (up to 2 weeks), and an intervention period of at least 52 weeks and up to 104 weeks. 800 participants will be randomized in a 1:1 ratio to receive mepolizumab 100 milligrams (mg) or placebo every 4 weeks for at least 13 doses (52 weeks treatment period) up to a maximum of 26 doses (104 weeks treatment period). The number of randomized participants may increase up to approximately 1400.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

Adults over 40 with frequent COPD exacerbations and certain levels of blood eosinophils, who are current or former smokers. They must have used specific inhaled medications for the past year and not be pregnant or breastfeeding. Excluded are those with other lung diseases, asthma, recent lung infections or surgeries, drug abuse history, and certain medical conditions.

Inclusion Criteria

I've been on a specific COPD treatment plan for the last 12 months.

I have had at least 2 moderate or 1 severe COPD flare-up in the last year.

Contraceptive use for female participant should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Exclusion Criteria

I had lung surgery in the last year and joined a lung rehab program within the last month.

You have conditions that could cause high levels of eosinophils, or you have a pre-existing parasitic infection or weakened immune system.

I have not recently used certain drugs or have allergies to study treatments.

Treatment Details

Interventions

• Mepolizumab (Monoclonal Antibodies)

Trial Overview The trial is testing Mepolizumab as an additional treatment for COPD against a placebo. Participants will receive either the actual drug or a placebo every four weeks for up to two years while continuing their usual COPD treatments.

Participant Groups

Group I: Mepolizumab Experimental Treatment 1 Intervention

Participants will receive mepolizumab subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.

Group II: Placebo Placebo Group 1 Intervention

Participants will receive placebo subcutaneously once every 4 weeks over a treatment period of at least 52 weeks up to a maximum of 104 weeks.

Who Is Running the Clinical Trial?

GlaxoSmithKline

Lead Sponsor

Trials

4,834

Recruited

8,389,000+

Headquarters

London, UK

Known For

Vaccines & Medicines

Top Products

**Advair (salmeterol, fluticasone propionate)**, **Shingrix (shingles vaccine)**, **Augmentin (amoxicillin/clavulanate potassium)**, **Ventolin (salbutamol sulfate)

Dame Emma Walmsley

GlaxoSmithKline

Chief Executive Officer since 2017

MA in Classics and Modern Languages from Oxford University

Dr. Hal Barron

GlaxoSmithKline

Chief Medical Officer since 2018

MD from Harvard Medical School

PPD DEVELOPMENT, LP

Industry Sponsor

Trials

167

Recruited

38,000+

David Simmons

PPD DEVELOPMENT, LP

Chief Executive Officer since 2012

BSc in Applied Science from Georgia Institute of Technology

Martina Flammer

PPD DEVELOPMENT, LP

Chief Medical Officer since 2024

MD

PPD

Industry Sponsor

Trials

162

Recruited

36,600+

Dr. Austin Smith

PPD

Chief Medical Officer since 2020

Doctor of Medicine from the Royal College of Surgeons in Ireland

David Simmons

PPD

Chief Executive Officer since 2012

Bachelor’s degree in Applied Mathematics and Industrial Management from Carnegie Mellon University