Dose Ranging Study of Lunsekimig Compared With Placebo-control in Adult Participants With Moderate-to-severe Asthma
- Registration Number
- NCT06102005
- Lead Sponsor
- Sanofi
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 685
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lunsekimig Dose 2 interval 2 Lunsekimig Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2 Lunsekimig Dose 2 interval 1 Lunsekimig Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1 Lunsekimig Dose 1 interval 2 Lunsekimig Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2 Placebo Placebo Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2 Lunsekimig Dose1 interval 1 Lunsekimig Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1
- Primary Outcome Measures
Name Time Method Annualized rate of asthma exacerbation events From baseline to week 48
- Secondary Outcome Measures
Name Time Method Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores From baseline to week 48 Disease-specific instrument designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Scores range from 0 to 100, with higher scores indicating more limitations.
Proportion of participants with ≥4-point improvement in SGRQ score From baseline to week 48 Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores From baseline to week 48 Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores From baseline to week 48 Change from baseline in ACQ scores From baseline to week 48 Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs) From baseline to week 52 Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score From baseline to week 48 ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
Change from baseline in ACQ-5 score From baseline to week 48 Change from baseline in FeNO From baseline to week 48 Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit From baseline to week 48 Average number of inhalations per day of short-acting beta 2-agoinst (SABA), Low dose ICS/formoterol or ICS/SABA for symptom relief From baseline to week 48 Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score From baseline to week 48 Serum lunsekimig concentrations From baseline to week 52 Time to first asthma exacerbation From baseline to week 48 Anti-drug antibodies (ADA) against lunsekimig From baseline to week 52 Change from baseline in pre-bronchodilator (BD) FEV1 From baseline to week 48 Change from baseline in post-BD FEV1 From baseline to week 48 The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD) From baseline to week 48
Trial Locations
- Locations (156)
Allergy, Asthma & Immunology Associates- Site Number : 8400009
🇺🇸Scottsdale, Arizona, United States
Yuma Pulmonary & Sleep Research, LLC- Site Number : 8400072
🇺🇸Yuma, Arizona, United States
Antelope Valley Clinical Trials- Site Number : 8400020
🇺🇸Lancaster, California, United States
Amicis Research Center - Northridge - Nordhoff Street- Site Number : 8400032
🇺🇸Northridge, California, United States
Optimus Medical- Site Number : 8400046
🇺🇸San Francisco, California, United States
Allergy and Asthma Associates of Santa Clara Valley Research Center- Site Number : 8400038
🇺🇸San Jose, California, United States
Clinical Trials Management Services - Thousand Oaks- Site Number : 8400053
🇺🇸Thousand Oaks, California, United States
Allianz Research Institute CO- Site Number : 8400026
🇺🇸Aurora, Colorado, United States
Velocity Clinical Research - Denver- Site Number : 8400027
🇺🇸Englewood, Colorado, United States
Western States Clinical Research- Site Number : 8400014
🇺🇸Wheat Ridge, Colorado, United States
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