Depemokimab for Asthma

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: GlaxoSmithKline

Must be taking: Inhaled corticosteroids

Must not be taking: Monoclonal antibodies

Disqualifiers: COPD, Cancer, Cardiac, 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: 52 weeks

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test how a new treatment, depemokimab, affects the lungs of people with asthma. The focus is on those with type 2 inflammation, a specific type of asthma characterized by high levels of eosinophils, a type of white blood cell. The trial seeks participants who have had asthma for more than two years, experience frequent flare-ups, and continue to have symptoms despite using asthma medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the development of a potentially groundbreaking treatment.

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

The trial does not specify if you need to stop your current medications. However, you must be on regular treatment with medium or high dose inhaled corticosteroids and at least one additional asthma controller medication for at least 3 months before joining the trial.

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

Research has shown that depemokimab is generally well-tolerated and significantly improves asthma symptoms compared to a placebo. Designed for twice-yearly use, the treatment offers convenience. Although detailed reports of serious side effects are lacking, its development as a long-acting biological drug involved rigorous safety testing. Since this study is in Phase 3, earlier phases have already provided evidence of its safety for humans. ^{1 2 3 4 5}

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

Depemokimab is unique because it specifically targets type 2 inflammation in asthma, which is different from many existing treatments that often focus on broad symptom relief or bronchodilation. Unlike traditional options like inhaled corticosteroids or bronchodilators, Depemokimab acts by inhibiting interleukin-5, a key player in the inflammatory process. Researchers are excited about this treatment because it offers a more targeted approach, potentially leading to better control of asthma symptoms with fewer side effects.

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

Research has shown that depemokimab, the treatment under study in this trial, can significantly benefit people with asthma, particularly those with type 2 inflammation linked to high levels of eosinophils, a type of white blood cell. In earlier studies, participants using depemokimab experienced 54% fewer severe asthma flare-ups, meaning fewer sudden attacks or worsening of symptoms. The treatment also offered long-lasting control of inflammation, helping to keep airways open and reduce asthma symptoms. Overall, depemokimab has demonstrated strong results in improving asthma management. ^{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?

This trial is for adults with asthma diagnosed at least 2 years ago, showing signs of type 2 inflammation (eosinophil count >=300 cells/mcL and FeNO >=25 ppb). They must have had at least two severe episodes in the past year despite using medium to high dose inhalers. Women must not be pregnant or breastfeeding and use effective contraception. Participants need uncontrolled asthma indicated by an ACQ-5 score >1.5.

Inclusion Criteria

Uncontrolled asthma indicated by ACQ-5 > 1.5

Additional criteria for biopsy sub-study participants

I can sign and understand the consent form.

Exclusion Criteria

Conditions leading to elevated eosinophils

History of alcohol misuse or substance abuse within 2 years

Pregnancy or breastfeeding

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive depemokimab to assess its effect on lung structure and function

52 weeks

Regular visits for assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

13 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Depemokimab

Trial Overview The study tests depemokimab's effects on lung structure and function in asthmatics with type 2 inflammation. It involves imaging and bronchoscopy to assess changes after treatment with this monoclonal antibody designed to target specific pathways involved in asthma-related inflammation.

How Is the Trial Designed?

Group I: Depemokimab Experimental Treatment 1 Intervention

Participants with asthma with type 2 inflammation will receive depemokimab.

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. gsk.com gsk.com/en-gb/media/press-releases/depemokimab-late-breaking-data-presented-at-ers-show-a-54-reduction-in-severe-asthma-exacerbations/

Depemokimab late-breaking data presented at ERS show ... SWIFT-1 and SWIFT-2 phase III data show depemokimab delivered statistically significant and clinically meaningful reduction in ...

2. atsjournals.org atsjournals.org/doi/abs/10.1164/ajrccm.2025.211.Abstracts.A5028

Pooled Data From the Phase III SWIFT-1/2 Studies Depemokimab treatment significantly reduced the annualized exacerbation rate by 54% with sustained inhibition of type 2 inflammation observed in patients with ...

3. 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 ...

4. jacionline.org jacionline.org/article/S0091-6749(24)02323-6/fulltext

Depemokimab Reduces Exacerbations in Patients With ... Depemokimab Reduces Exacerbations in Patients With Type 2 Asthma Characterized by Blood Eosinophils Across a Range of Blood Eosinophil and IgE Levels: SWIFT ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0140673625001977

Articles Efficacy and safety of twice per year depemokimab ... Depemokimab significantly improved clinically relevant coprimary endpoints versus placebo and was well tolerated, supporting its use as a twice per year ...

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

Efficacy and safety of twice per year depemokimab in ... Depemokimab significantly improved clinically relevant coprimary endpoints versus placebo and was well tolerated, supporting its use as a twice per year ...

7. thelancet.com thelancet.com/journals/lancet/article/PIIS0140-6736(25)00197-7/abstract

Efficacy and safety of twice per year depemokimab in ... Depemokimab is the first ultra-long-acting biological drug engineered with enhanced interleukin-5 binding affinity, high potency, and an ...