Dose-ranging study to assess the efficacy, safety, and tolerability of SAR440340 (anti-IL-33 mAb) in patients with moderate-to-severe asthma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 1120

Inclusion Criteria

-Participant must be = 18 years to = 75 of age inclusive (or the minimum legal age for majority in the country of the investigational site).
-Adult participants with a physician diagnosis of asthma for at least 12 months prior to screening (Visit 1) based on the Global Initiative for Asthma (GINA) 2019 Guidelines.
-Existing treatment with medium to high dose ICS (=500 mcg of fluticasone propionate daily or equipotent ICS daily dosage to a maximum of 2000 mcg/day of fluticasone propionate or equivalent) in combination with a LABA. Up to two additional controller medications are allowed (LAMA and/or LTRA). Current treatment should be initiated at least 3 months prior to Visit 1 and should be stable = 1 month prior to Visit 1.
-Pre-bronchodilator forced expiratory volume (FEV1) =40% and =80% of predicted normal at Visits 1 and 2, prior to randomization.
-Asthma Control Questionnaire 5-question version (ACQ-5) score =1.5 at Visits 1 and 2, prior to randomization.
-Patients with reversibility of at least 12% and 200 mL in FEV1 after administration of 2 to 4 puffs (200-400 mcg) of albuterol/salbutamol or levalbuterol/levosalbutamol during screening.
-Must have experienced, within 1 year prior to Visit 1, any of the following events:
• At least two episodes of treatment with a systemic steroid (oral or parenteral) for worsening asthma;
OR
• One episode of hospitalization for worsening asthma.
-Capable of giving signed informed consent.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 974
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 146

Exclusion Criteria

-Chronic obstructive pulmonary disease (COPD) or other lung diseases (eg, idiopathic pulmonary fibro-sis, etc) which may impair lung function or another diagnosed pulmonary or systemic disease.
-Either clinical or imaging (Chest X-ray, CT, MRI) evidence of lung disease(s) other than asthma within 12 months of Visit 1.
-A subject who experiences a severe asthma exacerbation at any time from 4 weeks prior to the Screening (Visit 1) up to and including the Baseline Visit (Visit 2).
-History of life threatening asthma in past 1 year prior to screening.
-Current smoker or cessation of smoking within 6 months prior to Visit 1. Current vaping or cessation of vaping within 6 months prior to Visit 1 is also not allowed.
-A patient with a history of clinically significant renal, hepatic, cardiovascular, metabolic, neurologic, hematologic, ophthalmologic, respiratory, gastrointestinal, cerebrovascular or other significant medical illness or disorder.
-Patients with a history of a systemic hypersensitivity reaction to a monoclonal antibody.
-Anti-IgE therapy within 130 days prior to Visit 1 or any other biologic therapy or systemic immunosuppressant to treat inflammatory disease or autoimmune disease and other diseases, within 2 months or 5 half-lives prior to Visit 1, whichever is longer.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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