Nimble - Possible new medicine for Adults and Adolescents with Eosinophilic Asthma

Severe Asthma with an Eosinophilic Phenotype

In eosinophilic asthma, normal white blood cells called ‘eosinophils’ are increased in number. This may cause inflammation (swelling) of the airways, leading to severe asthma attacks. It is hoped that the study drug can reduce the number of eosinophils and, therefore, the number of asthma attacks.

The study drug is being developed as an additional therapy for people with eosinophilic asthma who are already taking their usual asthma controller medicines. It is hoped that receiving the study drug every 6 months (26 weeks) will control your asthma symptoms, compared to medicines already used to treat your condition, such as mepolizumab and benralizumab, which are taken every 1 to 2 months (4 to 8 weeks). It is hoped that this may make your asthma care feel less overwhelming in the future for people with eosinophilic asthma.

Category
Respiratory, Infectious Disease and Oncology
Trial status
Recruiting
Trial phase
Phase 3 Drug Trial
Late stage studies conducted to confirm efficacy and safety of investigational therapies in large patient populations prior to introduction to clinical practice.
Registry listing
ClinicalTrials.gov: NCT04718389
ERM Project ID
76537

Trial contact details

Contact person
RIO Clinical Trials Unit
Email
RIOClinicalTrials@mater.org.au
Phone
07 3163 1369

What you need to know

Who can take part?

Key inclusion criteria for study:

Adult and adolescent participants more than or equal to (>=)12 years of age, at the time of signing the informed consent/assent.
Participants who have a documented physician diagnosis of asthma for >=2 years that meets the National Heart, Lung, and Blood Institute guidelines (NHLBI) or Global Initiative for Asthma (GINA) guidelines.
Participants receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for >=12 months prior to screening and have a documented benefit to therapy assessed by either:

(i) >=50% reduction in exacerbation frequency since initiating treatment, or (ii) >=50% reduction in maintenance OCS use since initiating treatment, or (iii) No exacerbations in the past 6 months whilst receiving anti-IL-5/5R therapy and an Asthma Control Questionnaire (ACQ)-5 score of less than or equal to (=440 micrograms (mcg) fluticasone propionate (FP) hydrofluoroalkane (HFA) product daily, or clinically comparable. Participants who are treated with medium dose ICS will also need to be treated with a LABA to qualify for inclusion.

Current treatment with at least one additional controller medication, besides ICS [for example (e.g.), LABA, LAMA, leukotriene receptor antagonist (LTRA), or theophylline].