Severe Eosinophilic Asthma MedDRA version: 20.0 Level: LLT Classification code 10068462 Term: Eosinophilic asthma System Organ Class: 100000004855
Conditions
Sponsors
AnaptysBio Inc
Eligibility
Sex/Gender
All
Inclusion criteria
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 requirements. • Have the ability to read and understand the study procedures and can communicate meaningfully with the Investigator and staff. For additional details refer to the study protocol. 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 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 2
Exclusion criteria
Exclusion criteria: • Have concomitant medical condition(s) which may interfere with the Investigator's ability to evaluate the patient's response to the IP. • Have experienced severe life threatening anaphylactic reactions. • Have received any IP within a period of 3 months or 5 half lives of an IP • Have received high dose systemic corticosteroids • Have received treatment with biologics within 3 months or 5 half lives (whichever is longer) before screening. • Abnormal ECG assessment at screening • Uncontrolled hypertension, or acute ischemic cardiovascular diseases. • If female, is pregnant or lactating, or intend to become pregnant during the study period. • History (or suspected history) of alcohol or substance abuse within 2 years before screening. • Any comorbidity that the Investigator believes is a contraindication to study participation. • Have any other physical, mental, or medical conditions which, in the opinion of the Investigator, make study participation inadvisable or could confound study assessments. • Planned surgery during the study or 30 days before screening. • History of malignancy within 5 years, except non melanoma skin cancer which has been fully treated with no current active disease. For additional details refer to the study protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 ; Secondary Objective: • Change in respiratory function • Describe Limited Pharmacokinetics • Test for immunogenicity • Describe Limited Pharmacodynamics ; Primary end point(s): • Number of participants with treatment-related adverse events as assessed by CTCAE v. 4.0 • Monitor peripheral blood eosinophil counts ;Timepoint(s) of evaluation of this end point: Throughout the duration of the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
United Kingdom, United States
Contacts
Public ContactAnaptysBio Clinical Trials Info
AnaptysBio Inc
Outcome results
None listed