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

NCT06102005

CompletedPhase 2

Sponsor: Sanofi

Conditions: Asthma

Interventions: Lunsekimig, Placebo

Countries: United States, Argentina, Brazil, Canada, Chile, China, India, Israel

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 overview

Sex: ALL

Age: 18 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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

Locations (156)

Scottsdale, Arizona, United States
Yuma, Arizona, United States
Lancaster, California, United States
Northridge, California, United States
San Francisco, California, United States
San Jose, California, United States
Thousand Oaks, California, United States
Aurora, Colorado, United States
Englewood, Colorado, United States
Wheat Ridge, Colorado, United States
Cutler Bay, Florida, United States
Hialeah, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami Lakes, Florida, United States
New Port Richey, Florida, United States
Pembroke Pines, Florida, United States
Sarasota, Florida, United States
Calhoun, Georgia, United States
Champaign, Illinois, United States
Lafayette, Louisiana, United States
Annapolis, Maryland, United States
Boston, Massachusetts, United States
Ann Arbor, Michigan, United States
Mankato, Minnesota, United States
St Louis, Missouri, United States
Middletown, New York, United States
New York, New York, United States
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