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?

This trial explores a new treatment called depemokimab, an experimental drug, for individuals with moderate to severe COPD (Chronic Obstructive Pulmonary Disease) who frequently experience flare-ups and have type 2 inflammation. The researchers aim to assess the effectiveness and safety of depemokimab when added to regular COPD treatments. Participants will receive either depemokimab or a placebo alongside their standard care. This trial may suit individuals with COPD who have had at least two flare-ups in the past year and are current or former heavy smokers. As a Phase 3 trial, it represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment.

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 participants to be on optimized inhaler therapy for at least 6 months before joining. This means you should continue your inhaler medications.

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

Research has shown that depemokimab has been tested for safety in individuals with conditions similar to COPD, such as asthma and chronic sinus problems. In these studies, participants generally tolerated depemokimab well. The FDA is currently reviewing the treatment for these other conditions, indicating it has already undergone numerous safety evaluations. No major safety issues have been reported so far, but like any medication, some side effects can occur, including mild reactions like pain at the injection site. Overall, past studies have demonstrated a good safety record for the treatment. ^{1 2 3 4 5}

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

Depemokimab is unique because it targets specific inflammatory pathways involved in chronic obstructive pulmonary disease (COPD), potentially offering a new approach to managing this condition. Unlike many current treatments, which primarily focus on bronchodilation and symptom relief, Depemokimab works by modulating the immune response, reducing inflammation at its source. This novel mechanism of action could lead to better long-term outcomes for patients, making researchers excited about its potential to change the standard of care for COPD.

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

Studies have shown that depemokimab may benefit people with moderate to severe COPD (Chronic Obstructive Pulmonary Disease) who also have type 2 inflammation. Research indicates that depemokimab targets specific parts of the immune system responsible for inflammation, a major issue in COPD. Early results suggest that adding depemokimab to existing treatments can help control symptoms and improve breathing. In this trial, participants will receive either depemokimab or a placebo, both alongside standard care. Researchers are also studying this drug for asthma treatment, which involves similar inflammation, increasing confidence in its potential benefits. Overall, depemokimab appears promising for managing COPD symptoms in patients with type 2 inflammation. ^{1 2 3 6 7}

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

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

Depemokimab applications accepted for review by the US ... The proposed indications are as add-on maintenance treatment of asthma in adult and pediatric patients aged 12 years and older with type 2 inflammation.

5. patlynk.com patlynk.com/trial/NCT07177339

Depemokimab for COPD with Type 2 Inflammation This study focuses on evaluating the effectiveness and safety of a medication called depemokimab for people who have moderate to severe Chronic Obstructive ...

6. 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 ...

7. 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 ...