Table of contents
- Trial overview
- Studies in chronic rhinosinusitis with nasal polyps
- Study in atopic dermatitis
- Study in high-risk asthma
- Main endpoints and what they mean
- Who can participate
Trial overview
The clinical trials of LUNSEKIMIG are all Phase 2 studies, which means they are testing how well the treatment may work and continuing to check safety in people with the disease.[1][2][3][4]
The listed studies include adults with chronic rhinosinusitis with nasal polyps, adults with moderate to severe atopic dermatitis, and adults with high-risk asthma.[1][2][3][4]
Two studies are marked completed, and two are marked authorised, so the program includes both finished research and ongoing research.[1][2][3][4]
Studies in chronic rhinosinusitis with nasal polyps
Two trials focus on chronic rhinosinusitis with nasal polyps (CRSwNP), a long-lasting condition where the nose and sinuses are inflamed and small growths called nasal polyps can appear inside the nose.[1][2]
The authorised study, NCT06914908, is a long-term safety and efficacy trial in adult participants with inadequately controlled CRSwNP who completed a previous LUNSEKIMIG CRSwNP study.[1]
Its main purpose is to evaluate long-term safety and tolerability, and the main outcome is the incidence of treatment-emergent adverse events, including adverse events of special interest and serious adverse events.[1]
The completed proof-of-concept study, 2024-511261-11-00, compared LUNSEKIMIG with placebo in adults with inadequately controlled CRSwNP.[2]
A proof-of-concept study is an early study that asks whether a treatment shows a sign that it may work in the target disease.[2]
This study also included mometasone, given by intranasal use, as part of the trial design.[2]
The main endpoint was the change in bilateral endoscopic nasal polyp score, which is a doctor-measured score showing how large or severe the nasal polyps are inside both sides of the nose.[2]
Study in atopic dermatitis
The completed trial 2024-511549-20-00 studied subcutaneous LUNSEKIMIG in adults with moderate to severe atopic dermatitis, which is also called eczema.[3]
This study compared LUNSEKIMIG with placebo and looked at different dosing regimens, meaning different planned ways of giving the study treatment.[3]
The main endpoint was the percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24.[3]
The EASI score is a tool used to measure how bad eczema is by looking at the area of skin involved and how severe the signs are.[3]
Study in high-risk asthma
The authorised trial NCT06676319 studies LUNSEKIMIG in adults with high-risk asthma compared with placebo.[4]
Asthma is a disease that can make the airways swollen and narrow, which can lead to breathing problems and flare-ups.[4]
The study is interventional, meaning participants receive a study treatment and the researchers then measure the results.[4]
The main endpoint is the annualized rate of asthma exacerbation events, which means how often asthma flare-ups happen over a year.[4]
Main endpoints and what they mean
The trials use different endpoints, which are the main results researchers measure to judge the study.[1][2][3][4]
Safety endpoints: The CRSwNP long-term study measures treatment-emergent adverse events, adverse events of special interest, and serious adverse events.[1]
Nasal polyp score: The CRSwNP proof-of-concept study measures change in bilateral endoscopic nasal polyp score, which shows whether the polyps became smaller or less severe.[2]
EASI score: The atopic dermatitis study measures percent change in EASI from baseline to Week 24, showing whether skin symptoms improved over time.[3]
Asthma exacerbation rate: The asthma study measures the annualized rate of asthma exacerbations, which tells how often major flare-ups happen in a year.[4]
Who can participate
These studies are designed for adults, not children, based on the trial data provided.[1][2][3][4]
For the CRSwNP studies, participants had inadequately controlled disease, and one study required people who had already completed a previous LUNSEKIMIG CRSwNP study.[1][2]
For the skin study, adults had moderate to severe atopic dermatitis, and for the asthma study, adults had high-risk asthma.[3][4]
Because the studies compare LUNSEKIMIG with placebo, some participants receive the study treatment while others receive a matched look-alike treatment with no active study drug.[2][3][4]
