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

Study on Investigational Medication for Moderate-to-Severe Asthma (a condition where the airways in the lungs become swollen and narrow, making it hard to breathe)

Recruiting
18 years - 80 years
All
Phase 2
630 participants needed
26 Locations

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 29 May 2024. Study ID: NCT06102005

This study investigates the effects of an investigational medication as an add-on therapy for adults with moderate-to-severe asthma. Asthma is a condition where the airways in the lungs become swollen and narrow, making it hard to breathe. The purpose of this study is to evaluate how well the investigational medication works, and how safe and tolerable it is for participants between the ages of 18 and 80.

Participants in this study will be randomly assigned to different study arms. Some will receive the investigational medication, while others will receive a placebo. A placebo is an inactive substance that looks like the investigational medication but does not contain any medicine. The study will be conducted in multiple centers around the world, and all participants will receive their treatment through injections under the skin.

  • Who can participate: Adults aged 18 to 80 with moderate-to-severe asthma diagnosed by a physician can participate. They must have stable treatment with inhaled corticosteroids and other controllers, and have had at least one exacerbation in the past year.
  • Study details: Participants will receive either the investigational medication or a placebo. The study involves injections given under the skin.

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