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

Sponsors and collaborators