Depemokimab for Chronic Obstructive Pulmonary Disease

(VIGILANT Trial)

Recruiting at 5 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: ICS, LABA, LAMA

Disqualifiers: Asthma, Other lung diseases, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 156 weeks

1196 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called depemokimab for individuals with moderate to severe Chronic Obstructive Pulmonary Disease (COPD) who have type 2 inflammation. The researchers aim to determine if adding depemokimab to current treatments can better manage COPD symptoms. Eligible participants should have had COPD for at least a year, a history of smoking, and frequent flare-ups or worsening symptoms. Participants will receive either depemokimab or a placebo, alongside their usual care. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking advancements in COPD treatment.

Do I need to stop my current medications to join the trial?

The trial does not specify if you need to stop your current medications. However, it mentions that participants should be on dual or triple inhaler therapy for at least 3 months, so you may need to continue those treatments.

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

Research has shown that depemokimab is being tested for safety in people with moderate to severe COPD (Chronic Obstructive Pulmonary Disease). Although specific safety data from past trials may not be available, depemokimab is under FDA review for other conditions, such as asthma with type 2 inflammation. This indicates some existing safety information for its use in similar conditions.

Treatments reaching this trial stage have generally demonstrated a certain level of safety in earlier studies. Depemokimab has been tested before and did not reveal any major safety issues that would halt further research. However, since this is a new application for COPD, the current trial will confirm how well people tolerate it. Participants will continue their regular COPD treatment alongside this new medicine to help ensure safety. ^{1 2 3 4 5}

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

Unlike the standard care for Chronic Obstructive Pulmonary Disease (COPD), which typically includes bronchodilators and inhaled corticosteroids, Depemokimab targets Type 2 inflammation specifically. This is exciting because it works differently from other treatments by focusing on the underlying inflammatory processes that can worsen COPD. Researchers are hopeful that by addressing this specific pathway, Depemokimab could provide more effective symptom relief and better management of the disease.

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

Research has shown that depemokimab might help people with moderate to severe COPD. In the SWIFT-1/2 studies, depemokimab significantly reduced symptom flare-ups and maintained lower inflammation levels over time. Researchers measured inflammation by a decrease in blood eosinophil levels, a type of white blood cell. This suggests depemokimab may help manage COPD by reducing the number of symptom episodes. In this trial, participants will receive either depemokimab or a placebo, both in combination with existing standard care, to test its effectiveness as an addition to current COPD treatment. ^{1 2 4 6 7}

Who Is on the Research Team?

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Are You a Good Fit for This Trial?

This trial is for adults with a history of moderate to severe COPD for at least one year, experiencing significant breathlessness and scoring high on the COPD Assessment Test. Participants must have reduced lung function after using a bronchodilator, only one moderate flare-up in the past year, signs of type 2 inflammation (eosinophils), chronic bronchitis, and a smoking history of 10 or more pack-years.

Inclusion Criteria

I have smoked at least 10 pack-years.

My lung function is less than half of what's expected after medication.

I am either male or meet the criteria for female participation.

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 in combination with Standard of Care for COPD

156 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 tests depemokimab as an additional treatment for those with COPD showing type 2 inflammation. It compares the effects of starting depemokimab early versus a placebo to see if it improves symptoms or prevents worsening.

How Is the Trial Designed?

Group I: Placebo Experimental Treatment 1 Intervention

Participants with COPD with Type 2 inflammation will receive matching Placebo in combination with existing SoC.

Group II: Depemokimab Experimental Treatment 1 Intervention

Participants with Chronic Obstructive Pulmonary Disorder (COPD) with Type 2 inflammation will receive Depemokimab in combination with existing Standard of Care (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/NCT06961214

Study Details | NCT06961214 | Depemokimab as an ... 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 ...

2. 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 ...

3. thorax.bmj.com thorax.bmj.com/content/80/Suppl_2/A95.2

and high-dose ICS subgroups: Phase III SWIFT-1/2 studies In SWIFT-1/2, depemokimab significantly reduced exacerbations, with sustained suppression of inflammation as assessed by blood eosinophil count in patients with ...

4. gsk.com gsk.com/en-gb/media/press-releases/gsk-to-showcase-new-research-from-its-broad-respiratory-portfolio-at-the-european-respiratory-society-ers-congress-2025/

GSK to showcase new research from its broad respiratory ... Presentation of data from the ANCHOR-1 and ANCHOR-2 trials in CRSwNP will explore the potential impact of depemokimab on early and sustained ...

5. humanforschung-schweiz.ch humanforschung-schweiz.ch/en/trial-search/study-detail/67518/translate/en/?cHash=a136731b52e8930bc835c589aa2bccad

Depemokimab as a long-acting biologic in adults with ... All participants will continue their regular COPD treatment in addition to Depemokimab or the placebo. (BASEC). Disease under investigation.

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 ... The aim of this study is to assess the efficacy and safety of depemokimab as an add-on medicine in participants with uncontrolled moderate to severe COPD with ...