A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents Wit… (NCT07456033) | Clinical Trial Compass
Not Yet RecruitingPhase 3
A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma
456 participantsStarted 2026-03-06
Plain-language summary
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).
Who can participate
Age range12 Years
SexALL
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Inclusion Criteria:
* 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).
* A well-documented requirement for treatment with low to medium dose ICS/LABA (in the 12 months prior to screening visit. Treatment should be stable for 3 months prior to screening. If participants are taking Maintenance and Reliever Therapy/Single Maintenance and Reliever Therapy regularly, the total daily dose should be incorporated into the assessment of low or medium dose ICS.
* Study will limit enrolment to a maximum of 40 percent (%) of participants on low dose ICS/LABA.
* Sex and Contraceptive/Barrier Requirements Male or eligible female Parti…
What they're measuring
1
Annualized rate of clinically significant exacerbations