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

Trial Summary

What is the purpose of this trial?

Asthma is a chronic condition marked by narrowed and swollen airways due to inflammation leading to recurring symptoms that can vary and worsen unpredictably. The purpose of this study is to assess how depemokimab, a monoclonal antibody, affects the structure and function of the lungs in asthmatic participants with type 2 inflammation, characterized by an eosinophilic phenotype.

Research Team

GSK Clinical Trials

Principal Investigator

GlaxoSmithKline

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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