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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
685
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Annualized rate of asthma exacerbation events
Time frame: From baseline to week 48
Change from baseline in pre-bronchodilator (BD) FEV1
Time frame: From baseline to week 48
Change from baseline in post-BD FEV1
Time frame: From baseline to week 48
The absolute change in the percent predicted FEV1 from baseline (pre-BD and post-BD)
Time frame: From baseline to week 48
Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score
ACQ-5 is Asthma control questionnaire assessing symptoms. Lower score shows better asthma control
Time frame: From baseline to week 48
Change from baseline in ACQ-5 score
Time frame: From baseline to week 48
Change from baseline in FeNO
Time frame: From baseline to week 48
Time to first asthma exacerbation
Time frame: From baseline to week 48
Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit
Time frame: 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
Time frame: From baseline to week 48
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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
...and 146 more locations
Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores
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.
Time frame: From baseline to week 48
Proportion of participants with ≥4-point improvement in SGRQ score
Time frame: From baseline to week 48
Change from baseline in Asthma Quality of Life Questionnaire Standardized for 12 years and older (AQLQ{S} +12) scores
Time frame: From baseline to week 48
Proportion of participants with ≥0.5-point improvement in AQLQ(S)+12 domain and total scores
Time frame: From baseline to week 48
Change from baseline in ACQ scores
Time frame: From baseline to week 48
Proportion of participants with ≥0.5-point reduction in ACQ-6 and ACQ-7 score
Time frame: From baseline to week 48
Serum lunsekimig concentrations
Time frame: From baseline to week 52
Anti-drug antibodies (ADA) against lunsekimig
Time frame: From baseline to week 52
Incidence of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interests (AESIs), serious adverse events (SAEs)
Time frame: From baseline to week 52