Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma

Investigational Medication for Moderate-to-Severe Asthma

Not Recruiting
18 years - 80 years
All
Phase 2
685 participants needed

Study Overview

This is a Phase 2b, global, multicenter, randomized, double-blind, placebo-controlled, parallel group, dose ranging study to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig in adult participants aged 18 to 80 years, (inclusive) with moderate-to-severe asthma.

Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: 18 years - 80 years
  • Gender: All

Inclusion Criteria:

  • A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5
  • Participants with existing treatment with moderate-to-high doses of ICS therapy for in combination with at least 1 but no more than 2 additional controller medications at least 3 months with a stable dose ≥1 month prior to Visit 1
  • At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy
  • ACQ-5 score more than 1.5 at Screening (Visit 1)

Exclusion Criteria:

  • Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease.
  • Current smoker or former smoker with cessation within 6 months of Screening or history of >10 pack-years. Active vaping of any products and/or marijuana smoking within 6 months of Screening.
  • Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening
  • Participants who have experienced an upper or lower respiratory tract infection within the 4 weeks prior to Screening
  • For participants on chronic OCS use for the maintenance treatment of asthma: history of a serious infection requiring hospitalization within the past 12 months prior to Randomization (Visit 2).
  • Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB (such as close contact with individuals with active or latent TB) or received Bacillus Calmette-Guérin (BCG)-vaccination within 12 weeks prior to Screening
  • Severe concomitant illness that would in the Investigator's opinion inhibit the participant's participation in the study, including for example, but not limited to, hypertension, renal disease, neurological conditions, heart failure and pulmonary disease
  • The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial

Updated on 17 Apr 2025. Study ID: NCT06102005

This study investigates the effects of an investigational medication added to the existing treatment of adults with moderate-to-severe asthma. Asthma is a condition where the airways in the lungs become inflamed and narrow, making it hard to breathe. The study will compare the investigational medication with a placebo, which is a substance that looks like the medication but does not contain any active ingredients.

Participants will be randomly assigned to different study arms, receiving either the investigational medication or a placebo. The study is double-blind, meaning neither the participants nor the researchers know who is receiving the actual medication. This helps ensure the results are unbiased. The study will monitor the participants' asthma symptoms and any side effects.

  • Who can participate: Adults aged 18 to 80 years with moderate-to-severe asthma, diagnosed by a physician for at least 12 months, may be eligible. Participants must have been on a stable dose of inhaled corticosteroids and other asthma medications for at least 3 months and have experienced at least one asthma exacerbation in the past year.
  • Study details: Participants will either receive the investigational medication or a placebo. A placebo is an inactive substance that looks like the investigational medicine but does not contain any medicine. The study will track asthma symptoms and any side effects.