In short
LUNSEKIMIG is being studied in clinical trials for several conditions, including chronic rhinosinusitis with nasal polyps, atopic dermatitis, and high-risk asthma. These studies look at safety, tolerability, and how well the treatment works in adults. The trials include people with ongoing disease who need better control of their symptoms.
Key points
- LUNSEKIMIG is being studied in Phase 2 clinical trials for chronic rhinosinusitis with nasal polyps, atopic dermatitis, and high-risk asthma. The trials are in adults and focus on both how well the treatment works and how safe it is. In chronic rhinosinusitis with nasal polyps, researchers measure nasal polyp scores and long-term safety. In atopic dermatitis, the main result is the change in Eczema Area and Severity Index, a skin severity score. In high-risk asthma, the main outcome is the yearly rate of asthma flare-ups. Two trials are completed and two are authorised.
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.
The listed studies include adults with chronic rhinosinusitis with nasal polyps, adults with moderate to severe atopic dermatitis, and adults with high-risk asthma.
Two studies are marked completed, and two are marked authorised, so the program includes both finished research and ongoing research.
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.
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.
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.
The completed proof-of-concept study, 2024-511261-11-00, compared LUNSEKIMIG with placebo in adults with inadequately controlled CRSwNP.
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.
This study also included mometasone, given by intranasal use, as part of the trial design.
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.
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.
This study compared LUNSEKIMIG with placebo and looked at different dosing regimens, meaning different planned ways of giving the study treatment.
The main endpoint was the percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24.
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.
Study in high-risk asthma
The authorised trial NCT06676319 studies LUNSEKIMIG in adults with high-risk asthma compared with placebo.
Asthma is a disease that can make the airways swollen and narrow, which can lead to breathing problems and flare-ups.
The study is interventional, meaning participants receive a study treatment and the researchers then measure the results.
The main endpoint is the annualized rate of asthma exacerbation events, which means how often asthma flare-ups happen over a year.
Main endpoints and what they mean
The trials use different endpoints, which are the main results researchers measure to judge the study.
- Safety endpoints: The CRSwNP long-term study measures treatment-emergent adverse events, adverse events of special interest, and serious adverse events.
- 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.
- EASI score: The atopic dermatitis study measures percent change in EASI from baseline to Week 24, showing whether skin symptoms improved over time.
- Asthma exacerbation rate: The asthma study measures the annualized rate of asthma exacerbations, which tells how often major flare-ups happen in a year.
Who can participate
These studies are designed for adults, not children, based on the trial data provided.
For the CRSwNP studies, participants had inadequately controlled disease, and one study required people who had already completed a previous LUNSEKIMIG CRSwNP study.
For the skin study, adults had moderate to severe atopic dermatitis, and for the asthma study, adults had high-risk asthma.
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.