Placebo-Controlled Proof of Concept Study to Investigate ANB020 Activity in Adult Patients with Severe Eosinophilic Asthma

INTERVENTION: Product Code: ANB020 Pharmaceutical Form: Solution for infusion INN or Proposed INN: anti‐IL‐33 monoclonal antibody Current Sponsor code: ANB020 Other descriptive name: Humanized monoclonal antibody Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 50‐ Pharmaceutical form of the placebo: Infusion Route of administration of the placebo: Intravenous use CONDITION: Severe Eosinophilic Asthma ; MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855 Therapeutic area: Diseases [C] ‐ Respiratory Tract Diseases [C08] PRIMARY OUTCOME: ; Main Objective: • Safety of ANB020 in adult patients with severe eosinophilic asthma: Number of participants with treatment‐related adverse events as; assessed by CTCAE v. 4.0; • Change in blood eosinophil count; ; Primary end point(s): • Number of participants with treatment‐related adverse events as assessed by CTCAE v. 4.0; • Monitor peripheral blood eosinophil counts; ; Secondary Objective: • Change in respiratory function; • Describe Limited Pharmacokinetics; • Test for immunogenicity; • Describe Limited Pharmacodynamics; Timepoint(s) of evaluation of this end point: Throughout the duration of the study SECONDARY OUTCOME: ; Secondary end point(s): • Monitor FEV1 variation ; • Maximum observed concentration (Cmax) and time to Cmax ; • Detection of ADA ; • Pharmacodynamic analysis; ; Timepoint(s) of evaluation of this end point: Throughout the duration of the study ; ; INCLUSION CRITERIA: • Male and female patients aged =18 to =65 years and able to give informed consent. • Patients with a confirmed clinical diagnosis of eosinophilic asthma • History of diagnosis of eosinophilic asthma • Severe asthma diagnosed according to the Global Initiative for Asthma (GINA) 2016 • Body mass index (BMI) of 18 to 38 kg/m2 (inclusive) and total body weight >50 kg (110 lb.). • Women of childbearing potential must have a negative serum pregnancy test at screening and be willing to use effective methods of contraception throughout the study. • Male patients must be willing to use effective methods of contraception during the entire study period. • Patient must be on high dose ICS plus LABA. • Willing and able to comply with the study protocol requirement