A Randomized, Double-blind, Placebo-controlled, Parallel-group, Dose Ranging Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Moderate-to-severe Asthma

Activo, no reclutaFase 2ClinicalTrials.gov

ID: NCT06102005Tipo: INTERVENTIONALInicio: 16 de oct de 2023Fin estimado: 23 de mar de 2026

Traducción no disponible, mostrando original

Resumen

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.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 80 YearsSexo: ALL

Criterios de inclusión

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)

Criterios de exclusión

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

Intervenciones

drug

Lunsekimig

Pharmaceutical form: solution for injection Route of administration: subcutaneous

drug

Placebo

Pharmaceutical form: solution for injection Route of administration: subcutaneous

Ubicaciones

Investigational Site Number : 0320007

Berazategui, Buenos Aires, Argentina

Investigational Site Number : 0320003

La Plata, Buenos Aires, Argentina

Investigational Site Number : 0320002

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320006

Rosario, Santa Fe Province, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0320004

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320009

Mendoza, Argentina

Investigational Site Number : 0320008

San Miguel de Tucumán, Argentina

Investigational Site Number : 0320010

Santa Fe, Argentina

Patrocinadores

PrincipalSanofi

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