Asthma
Conditions
Interventions
Drug: Amlitelimab
Injection solution Subcutaneous injection
Drug: Placebo
Injection solution Subcutaneous injection
Sponsors
obara Kentaro
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - The participant must be between the ages of 18 and 75 inclusive at the time of signing the informed consent. - Moderate to severe asthma diagnosed by a physician for >= 12 months according to stages 4 and 5 of the Global Initiative for Asthma (GINA ). - Participants on existing therapy with medium to high doses of ICS (>=500 micro g fluticasone propionate daily or comparable ICS dose in combination with at least one additional controller (e.g., long-acting beta agonist [LABA], leukotriene receptor antagonist [LTRA], long-acting muscarinic Antagonist [LAMA], methylxanthines) for at least 3 months. Note for Japan: participants must be on >=400 micro g of fluticasone propionate daily or equivalent. - >= 1 severe asthma exacerbation in the past year, with at least one exacerbation during treatment with medium to high doses of ICS (>= 500 micro g fluticasone propionate daily or one dose of ICS comparable). - Participants with pre-BD forced expiratory volume in 1 second (FEV1) > 40% and 1.5 at randomization. - Participants with at least 12% reversibility and 200 mL post-BD FEV after administration of albuterol/salbutamol or levalbuterol/levosalbutamol at screening or documented history of a reversibility test. - Weight >=40 kg and <=150 kg at the randomization visit.
Exclusion criteria
Exclusion criteria: Participants are excluded from the study if any of the following criteria apply: - Chronic lung disease other than asthma. - Current or former smoker including active vaping of any products and/or marijuana with cessation within 6 months of screening or history of >10 pack-years. - Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 1 month prior to screening. - Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to Screening; COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial. - Active infection or history of clinically significant infection - Known history of, or suspected, significant current immunosuppression, including history of invasive opportunistic or helminthic infections despite infection resolution or otherwise recurrent infections of abnormal frequency or prolonged duration. - Active or latent tuberculosis (TB) - A history of malignancy of any type (excluding basal and squamous cell skin cancer and in situ cervical carcinoma that has been excised and cured >3 years prior to baseline). - History of solid organ transplant. - Hepatitis B, C or HIV. - Pregnant or breastfeeding. - History (within last 2 years prior to Baseline) of prescription drug or substance abuse, including alcohol, considered significant by the Investigator. - Any prior use of anti-OX40 or anti-OX40L mAb, including amlitelimab - Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Annualized rate of severe exacerbation events over 48 weeks [Time Frame baseline:Baseline through Week 48] Severe exacerbation events are defined as: worsening of asthma requiring the use of systemic corticosteroids for >=3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Change from baseline in pre-bronchodilator (BD) FEV1 at Week 48 [Time Frame baseline:Baseline to Week 48] 2.Change from baseline in Asthma Control Questionnaire 5 (ACQ-5) score at Week 48 [Time Frame baseline:Baseline to Week 48] The ACQ-5 has five questions on the asthma symptoms. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control. 3.Change from baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ (S)) Self-Administered Score at Week 48 [Time Frame baseline:Baseline to Week 48] The AQLQ(S) is designed as a self-administered participant reported outcome to measure the functional impairments. The overall score is 1 to 7. Higher AQLQ scores indicate better health-related quality of life. 4.Change from baseline in post-BD FEV1 at Week 48 [Time Frame baseline:Baseline to Week 48] 5.The absolute change in the percent predicted FEV1 from baseline to Week 48 (pre-BD and post-BD) [Time Frame baseline:Baseline to Week 48] 6.Change from baseline in ACQ-5 score at Weeks 2, 4, 8, 12, 24, 36, and 60 [Time Frame baseline:Baseline to Weeks 2, 4, 8, 12, 24, 36, and 60] The ACQ-5 has five questions on the asthma symptoms. The score ranges from 0 (totally controlled) and 6 (severely uncontrolled). A high score indicates low asthma control. 7.Time to first severe exacerbation event [Time Frame baseline:Baseline through Week 48] Severe exacerbation events are defined as: worsening of asthma requiring the use of systemic corticosteroids for >=3 days or, in the case of a stable maintenance regimen of oral corticosteroids for the treatment of asthma, a doubling of the dose for 3 or more days; or hospitalization or emergency room visit because of asthma, requiring systemic corticosteroids. 8.Change from baseline in pre-BD and post-BD FEV1 [Time Frame baseline:Baseline to Weeks 2, 4, 8, 12,16, 24, 36 and 60] 9.Change from baseline in peak expiratory flow (PEF) and forced expiratory flow ( | — |
Countries
Argentina, Brazil, Canada, Chile, Hungary, Italy, Japan, Mexico, Poland, South Africa, Turkey, United Kingdom, United States
Contacts
Public ContactUnit Clinical
Sanofi K.K.
Outcome results
None listed