Depemokimab for COPD

(ENDURA-2 Trial)

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Inhaled corticosteroids, LAMA, LABA

Disqualifiers: Asthma, Other lung disease, 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: 104 weeks

960 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy and safety of depemokimab compared as an add-on medicine in participants with uncontrolled moderate to severe COPD with type 2 inflammation.

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

Adults aged 40-80 with moderate to severe COPD and type 2 inflammation can join this trial. They must have a history of exacerbations, specific lung function scores, and be on stable inhaler therapy. Smokers or former smokers with at least a 10 pack-year history are eligible. Women must meet certain criteria.

Inclusion Criteria

My blood test shows high eosinophil levels.

I have smoked at least 10 pack-years.

My BMI is at least 16 kg/m^2.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of Depemokimab or placebo along with standard of care

104 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Depemokimab

Trial Overview The study is testing Depemokimab as an add-on treatment for COPD patients with type 2 inflammation. It's compared against a placebo to see if it improves symptoms and lung function in participants who haven't responded well to other treatments.

How Is the Trial Designed?

Group I: Depemokimab Experimental Treatment 1 Intervention

Participants will be administered subcutaneous (SC) injection of Depemokimab along with standard of care (SoC).

Group II: Placebo Placebo Group 1 Intervention

Participants will be administered placebo along with SoC.

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