ClinicaliQ Trial Snapshot
- A Study of Efficacy and Safety of Depemokimab Compared With Placebo in Adults and Adolescents With at Risk Type 2 Asthma — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT07456033.
- What is being tested: Depemokimab, a novel biologic therapy, is being evaluated as an add-on treatment to standard care in Type 2 asthma patients at risk of exacerbations, with efficacy and safety compared against placebo.
- Patient eligibility overview: The trial includes adults and adolescents with Type 2 asthma who are at elevated risk of experiencing asthma exacerbations despite current guideline-recommended standard of care management.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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 Snapshot
- : * 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…
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.