Principal Investigator: Liam Heaney                                            

Name of the Study: NIMBLE

Why is this Study important?

Anti-IL-5 therapies have an established efficacy and long-term safety profile and are a cornerstone of severe asthma management for patients with an eosinophilic phenotype.

Long-acting (LA) alternatives that can be administered on a less frequent basis are recognised as successful approaches for chronic indications. Depemokimab is being developed as a LA SC injectable anti-IL-5 therapy. It is anticipated to have an efficacy and safety profile similar to those of the current-approved therapies in its class but with a reduced dosing frequency of a single administration every 26 weeks, as opposed to the current regimen of every 4 weeks for mepolizumab and reslizumab, or every 8 weeks for benralizumab.

What is the Research question/aim?:

A study to assess the exacerbation rate, additional measures of asthma control and safety in severely asthmatic adults and adolescents who have an eosinophilic phenotype treated with depemokimab compared with mepolizumab or benralizumab.

What the Study involves:

The study has a duration of a maximum of 66 weeks. After the Screening/Run-In Period, eligible participants will be randomised in a 1:1 ratio in a blinded manner to receive: Depemokimab plus Placebo matching the participant’s prior anti-IL-5/5R therapy OR participant’s prior anti-IL-5/5R therapy plus Placebo matching Depemokimab. The Treatment Period has a duration of 52 weeks and participants will be assessed at each scheduled visit, approximately monthly. The study visits include several safety and efficacy assessments alongside administration of the Investigational Medicinal Products such as: physical examination, electrocardiogram, questionnaires, vital signs, lung function, specimen collection for laboratory tests, assessment of adverse events, concomitant medications and asthma exacerbations. Daily electronic diary parameters including peak flow, rescue medication use, daily symptoms and nocturnal awakening due to asthma are also collected throughout the study. The Treatment Period is followed by a Follow-up Period of 4 weeks.

Who can take part in the Study?

Asthmatic Adult and adolescent participants 12yrs and older, and those receiving either mepolizumab 100 milligrams (mg) or benralizumab 30 mg for a year or more prior to screening and have a documented benefit to therapy assessed

Contact Information:

Abitha Nair Abitha.Nair@belfasttrust.hscni.net

BHSCT - Respiratory Research Office

Ground Floor, Tower Block

Belfast City Hospital

51 Lisburn Road

Belfast, BT9 7AB