A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma

ConditionAsthma
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12+
SponsorGlaxoSmithKline

About this trial

The aim of this study is to evaluate the efficacy of depemokimab administered as an adjunctive therapy, in participants with Type 2 asthma at risk of exacerbations compared to the guideline recommended standard of care (SoC).

Eligibility criteria

Qualifiers

Adults and adolescents >=12 years of age, at the time of signing the informed consent/assent. For countries where local regulations or the regulatory status of study medication permit enrolment of adults only, participants recruited will be >=18 years of age.

Participants must have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute, National Institute for Health and Care Excellence or Global Initiative for Asthma guidelines

Have previously confirmed history of at least 2 exacerbations over the last 3 years prior to screening, with at least 1 of those exacerbations occurring in the previous year prior to Screening Visit 1.

Exacerbation requiring treatment with systemic Corticosteroid (CS), for at least 3 days, despite the use of low to medium dose Inhaled corticosteroids (ICS)/ Long-acting beta2-adrenergic receptor agonist (LABA).

Disqualifiers

Participants have had 3 or more exacerbations in the last year prior to Visit 1.

Participants on maintenance OCS or high dose ICS/LABA for asthma.

Participants with a duration of asthma greater than (>)20 years.

Presence of a known pre-existing, clinically important lung condition other than asthma. This includes (but is not limited to) current infection, bronchiectasis, pulmonary fibrosis, bronchopulmonary aspergillosis, or a history of lung cancer. Participants with current diagnoses of emphysema or chronic bronchitis (Chronic Obstructive Pulmonary Disease other than asthma) are excluded.

Trial design

Treatments tested in this trial

  • Depemokimab
  • Placebo

Treatment groups

456 Participants
are divided into 2 treatment groups

Locations

8
GSK Investigational Site92663, Newport BeachCalifornia, United States
GSK Investigational Site33180, AventuraFlorida, United States
GSK Investigational Site34746, KissimmeeFlorida, United States
GSK Investigational Site33135, MiamiFlorida, United States

Sponsors and collaborators

GlaxoSmithKline

Lead sponsor