Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma

Ception Therapeutics

Status and phase

Completed

Phase 2

Conditions

Asthma

Treatments

Biological: Reslizumab

Other: Saline

Study type

Interventional

Funder types

Industry

Identifiers

Res-5-0010

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness and safety of reslizumab in the treatment of subjects with poorly controlled asthma.

Full description

Objectives:

Primary: To demonstrate the ability of reslizumab to improve asthma control in subjects with active asthma and eosinophilic airway inflammation.

Secondary:

To study the ability of reslizumab to reduce induced sputum eosinophil (EOS) counts in subjects with asthma.
To study the ability of reslizumab to reduce the number of eosinophilic clinical asthma exacerbations (CAE) in subjects with asthma. A CAE is defined as a ≥ 20% decrease in forced expiratory volume in 1 second (FEV1; absolute value) from the baseline value or a requirement for emergency treatment of asthma, hospital admission for asthma or treatment with three or more days of oral corticosteroids (OCS) for asthma worsening.
To assess the safety and tolerability of reslizumab in subjects with asthma.

Enrollment

106 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

written informed consent
male or female subjects aged ≥ 18 to 75 years at time of screening
female if she is of non-childbearing potential, or of childbearing potential and willing to use specific barrier methods specified in protocol
confirmation of asthma
symptoms consistent with a diagnosis of asthma that is poorly controlled with an inhaled corticosteroid as determined by an Asthma Control Questionnaire (ACQ) score ≥ 1.5
requirement for treatment with high dose daily fluticasone and at least one other agent for the treatment of asthma not specifically excluded in the protocol
requirement for >/= 3% eosinophils in induced sputum at Screening

Exclusion criteria

a clinically important event that would interfere with study schedule or procedure or compromise subject safety
a diagnosis of hypereosinophilic syndrome
an underlying lung disorder
a current smoker
use of systemic immunosuppressive agents within 6 months of study
current use of systemic corticosteroids
received attenuated live attenuated vaccines within three months prior to study entry
expected to be poorly compliant with study drug, procedures, visits
aggravating factors that are inadequately controlled
participation in any investigational drug or device study within 30 days prior to study entry
participation in biologics study within 3 months prior to study entry
receipt of anti-human interleukin-5 (hIL-5) antibody within 6 months of study entry
female subjects who are pregnant or nursing
concurrent infection or disease that may preclude assessment of eosinophilic esophagitis
concurrent immunodeficiency (human immunodeficiency [HIV], or acquired immunodeficiency syndrome [AIDS] or congenital immunodeficiency).
current suspected drug and/or alcohol abuse