Europas førende søgning efter kliniske forsøg

LUNSEKIMIG

LUNSEKIMIG is being studied in clinical trials for adults with chronic rhinosinusitis with nasal polyps, high-risk asthma, and moderate to severe atopic dermatitis. The trials mainly look at safety, tolerability, and how well the study treatment works compared with placebo. All studies are in adults, mostly in Phase 2.

Table of contents

Overview of the trials

These clinical trials study LUNSEKIMIG in adults with three different long-term conditions: chronic rhinosinusitis with nasal polyps, moderate to severe atopic dermatitis, and high-risk asthma.[1][2][3][4]

All four studies are Phase 2 trials, which means they are testing the treatment in people to learn more about benefit, safety, and how it compares with placebo.[1][2][3][4]

The studies are interventional, so the researchers give a study treatment and then measure the results over time.[1][2][3][4]

Trials in chronic rhinosinusitis with nasal polyps

Two trials focus on chronic rhinosinusitis with nasal polyps (CRSwNP), a long-lasting condition with inflammation in the nose and sinuses plus growths called nasal polyps.[1][2]

One authorised study, NCT06914908, looks at the long-term safety and efficacy of LUNSEKIMIG in adults who already completed a previous CRSwNP study.[1]

This study includes 67 participants and measures the incidence of treatment-emergent adverse events, adverse events of special interest, and serious adverse events.[1]

The other CRSwNP study, 2024-511261-11-00, is completed and compared LUNSEKIMIG with placebo in adults with inadequately controlled CRSwNP.[2]

This completed study also included mometasone, which was given by the nose, and it measured change in bilateral endoscopic nasal polyp score.[2]

Trial in atopic dermatitis

The completed study 2024-511549-20-00 tested LUNSEKIMIG in adults with moderate to severe atopic dermatitis, which is a skin condition that causes itchy and inflamed skin.[3]

This trial compared LUNSEKIMIG with placebo and included 220 participants.[3]

The main endpoint was the percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24, which shows how much the skin disease changed during the study.[3]

The study summary says it aimed to assess different dosing regimens and their effect on skin lesions in adults with moderate to severe disease.[3]

Trial in high-risk asthma

The authorised study NCT06676319 examines LUNSEKIMIG in adults with high-risk asthma.[4]

This is a large study with 2,468 participants, and it compares LUNSEKIMIG with placebo.[4]

The main outcome is the annualized rate of asthma exacerbation events, meaning how often asthma flare-ups happen over a year.[4]

The study summary says the goal is to evaluate the effect of LUNSEKIMIG on asthma exacerbations in adults with high-risk asthma.[4]

What the trials measure

The trials measure different endpoints, which are the main results researchers want to study.[1][2][3][4]

  • In CRSwNP, researchers measure nasal polyp score and long-term safety outcomes such as treatment-emergent adverse events and serious adverse events.[1][2]

  • In atopic dermatitis, researchers measure the percent change in EASI score from the start of treatment to Week 24.[3]

  • In asthma, researchers measure the annualized rate of asthma exacerbation events, which shows how often flare-ups occur over time.[4]

Who the trials include

All studies are in adult participants, not children.[1][2][3][4]

The CRSwNP studies include adults with inadequately controlled disease, and one long-term study includes people who already finished a previous LUNSEKIMIG CRSwNP study.[1][2]

The atopic dermatitis study includes adults with moderate to severe disease, and the asthma study includes adults with high-risk asthma.[3][4]

Trial status and size

Two trials are marked completed, and two trials are marked authorised.[1][2][3][4]

The smallest listed study includes 67 participants, and the largest includes 2,468 participants.[1][4]

Across the four studies, researchers are mainly checking whether LUNSEKIMIG can improve disease control and whether it is safe and tolerable in the studied adult groups.[1][2][3][4]

Trial ID Phase Condition studied Status Enrollment
NCT06914908 Phase 2 Chronic rhinosinusitis with nasal polyps Authorised 67
2024-511261-11-00 Phase 2 Chronic rhinosinusitis with nasal polyps Completed 146
2024-511549-20-00 Phase 2 Atopic dermatitis Completed 220
NCT06676319 Phase 2 High-risk asthma Authorised 2468

FAQ

  • What conditions are being studied with LUNSEKIMIG? The trials study chronic rhinosinusitis with nasal polyps, high-risk asthma, and moderate to severe atopic dermatitis. These are long-term inflammatory conditions that affect the nose, lungs, or skin.
  • Who can take part in these trials? The studies are in adults. Some trials include adults with inadequately controlled chronic rhinosinusitis with nasal polyps, while others include adults with high-risk asthma or moderate to severe atopic dermatitis.
  • What phase are the LUNSEKIMIG trials? All listed studies are Phase 2 trials. Phase 2 means the treatment is being tested in people to learn more about its effects, safety, and how it compares with placebo.
  • What are the trials trying to measure? The trials measure outcomes such as nasal polyp score, eczema severity, and asthma exacerbation rate. They also look at safety, including treatment-emergent adverse events and serious adverse events.
  • Are any of the studies completed? Yes. Two trials are completed: one in chronic rhinosinusitis with nasal polyps and one in atopic dermatitis. Two other trials are authorised and listed as ongoing.

Igangværende kliniske forsøg for LUNSEKIMIG

  • Undersøgelse af ny astmamedicin (lunsekimig) til voksne med svær astma

    Rekrutterer

    1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien Danmark Frankrig Tyskland Ungarn Italien +4

  • Langtidsundersøgelse af lægemidlet lunsekimig til voksne med kronisk bihulebetændelse og næsepolypper

    Rekrutterer ikke

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien Bulgarien Polen

  • Test af lægemidlet lunsekimig til behandling af moderat til svær atopisk eksem hos voksne

    Rekrutterer ikke

    1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Tjekkiet Polen

  • Afprøvning af lægemidlet lunsekimig til behandling af kronisk bihulebetændelse med næsepolypper hos voksne

    Rekrutterer ikke

    1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien Bulgarien Polen

Ordliste

  • Phase 2: A study stage where a treatment is tested in people to learn more about its effects and safety.
  • Placebo: A test treatment that looks like the study medicine but does not contain the active study drug.
  • Interventional study: A trial where researchers give a treatment and then measure what happens.
  • Chronic rhinosinusitis with nasal polyps (CRSwNP): A long-lasting condition with swelling in the nose and sinuses, plus growths called nasal polyps.
  • Nasal polyp score (NPS): A number that shows how many and how large the nasal polyps are.
  • Atopic dermatitis: A common skin condition that causes itchy, inflamed, and irritated skin.
  • Eczema Area and Severity Index (EASI): A score used to measure how severe eczema or atopic dermatitis is.
  • Asthma exacerbation: A flare-up where asthma gets worse and symptoms increase.
  • Treatment-emergent adverse events (TEAEs): Health problems that start or get worse after a person begins the study treatment.
  • Serious adverse events (SAEs): Severe health problems that may need urgent medical care or hospital treatment.

Referencer

  1. https://kliniske-forsoeg.dk/forsog/langtidsundersogelse-af-laegemidlet-lunsekimig-til-voksne-med-kronisk-bihulebetaendelse-og-naesepolypper/
  2. https://clinicaltrials.gov/study/2024-511261-11-00
  3. https://clinicaltrials.gov/study/2024-511549-20-00
  4. https://kliniske-forsoeg.dk/forsog/undersogelse-af-ny-astmamedicin-lunsekimig-til-voksne-med-svaer-astma/