Depemokimab for COPD

(ENDURA -1 Trial)

Recruiting at 13 trial locations

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

981 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores the effectiveness and safety of depemokimab when added to usual treatments for people with moderate to severe COPD, a lung disease that makes breathing difficult. It specifically targets those with uncontrolled symptoms linked to type 2 inflammation. Participants will receive either depemokimab or a placebo, alongside their standard care. Ideal candidates have managed COPD for at least a year and experience frequent flare-ups, despite optimized inhaler use. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications, but it requires that you continue using your optimized inhaler therapy, which includes inhaled corticosteroids, LAMA, and LABA, for at least 6 months before starting the trial.

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

Research has shown that depemokimab is generally safe for people. Previous studies have examined its use as an additional treatment for asthma and chronic sinus issues with nasal polyps, finding no major safety concerns. The FDA is also reviewing the drug for these conditions, indicating confidence in its safety.

Since this trial is in the later stages (Phase 3), evidence already suggests that depemokimab is safe and well-tolerated. This phase typically involves more participants and aims to confirm safety and effectiveness before approval. While no medication is without risks, depemokimab has shown promise as a safe treatment option for people with moderate to severe COPD. ^{1 2 3 4 5}

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

Unlike the standard of care for COPD, which typically includes bronchodilators and corticosteroids, Depemokimab acts on a different target. Researchers are excited about Depemokimab because it specifically targets and reduces eosinophils, a type of white blood cell involved in inflammation, which is not addressed by current treatments. This new mechanism of action could potentially offer better control of symptoms and reduce flare-ups, making it a promising option for COPD patients.

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

Studies have shown that depemokimab can reduce symptoms in people with moderate to severe COPD, a lung disease that makes breathing difficult, especially with type 2 inflammation. In this trial, participants will receive either depemokimab or a placebo, both alongside standard care. Previous studies demonstrated significant improvements in those who took depemokimab compared to those who took a placebo, which contains no active medicine. This treatment targets type 2 inflammation, believed to worsen COPD symptoms. Early research suggests this approach could help people with COPD breathe better and improve their quality of life. ^{1 2 6 7 8}

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, a history of exacerbations, and signs of type 2 inflammation can join. They must have smoked at least the equivalent of 10 pack-years and be on stable inhaler therapy. Pregnant women or those not using contraception are excluded.

Inclusion Criteria

I am either a male or a female eligible for the study.

My COPD symptoms score is 10 or higher.

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 depemokimab or placebo along with standard of care for COPD

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 trial is testing Depemokimab as an add-on treatment for COPD patients with type 2 inflammation. Participants will either receive Depemokimab or a placebo to compare effectiveness in controlling symptoms and improving lung function.

How Is the Trial Designed?

Group I: Depemokimab Experimental Treatment 1 Intervention

Participants will be administered 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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07177339

Study Details | NCT07177339 | eValuating the Efficacy and ... The aim of this study is to assess the efficacy and safety of early initiation of depemokimab as an add-on medicine in participants with moderate to severe COPD ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06961214

NCT06961214 | Depemokimab as an Extended treatmeNt ... 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 ...

3. trialx.com trialx.com/clinical-trials/listings/299919/depemokimab-as-an-extended-treatment-duration-biologic-in-adults-with-chronic-obstructive-pulmonary-disease-copd-and-type-2-inflammation-endura-2/

Depemokimab as an Extended treatmeNt Duration Biologic ... 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 ...

4. gsk.com gsk.com/media/nxuax2du/press-release-gsk-continues-to-advance-the-future-of-respiratory-medicine-and-patient-care-with-new-data-at-ats.pdf

Press release Mepolizumab Efficacy is Durable up to 104 Weeks in Patients with. Chronic Obstructive Pulmonary Disease: Results from the MATINEE. Phase III ...

5. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40037388/

Efficacy and safety of twice per year depemokimab in ... Depemokimab had statistically significant improvements from baseline versus placebo in the coprimary endpoints of total nasal polyps score ( ...

6. gsk.com gsk.com/en-gb/media/press-releases/depemokimab-applications-accepted-for-review-by-the-us-fda/

Depemokimab applications accepted for review by the US ... Depemokimab applications accepted for review by the US FDA for asthma with type 2 inflammation and for chronic rhinosinusitis with nasal polyps ...

7. ctv.veeva.com ctv.veeva.com/study/depemokimab-as-an-extended-treatment-duration-biologic-in-adults-with-chronic-obstructive-pulmonary

Depemokimab as an Extended treatmeNt Duration Biologic in ... Depemokimab is being developed as a treatment for individuals with moderate to severe COPD. The aim of this study is to assess the efficacy ...

8. gskusmedicalaffairs.com gskusmedicalaffairs.com/respiratory/pipeline/

Pipeline | Respiratory Chronic Obstructive Pulmonary Disease (COPD); Chronic Rhinosinusitis with ... OCEAN: Efficacy and Safety of Depemokimab Compared With Mepolizumab in Adults With ...