Efficacy and Safety Study of Reslizumab to Treat Poorly Controlled Asthma - Full Text View

Sponsor:	Ception Therapeutics
Information provided by:	Ception Therapeutics
ClinicalTrials.gov Identifier:	NCT00587288

Purpose

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

Condition	Intervention	Phase
Asthma	Biological: Reslizumab Other: Saline	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study
Official Title:	An Efficacy and Safety Study of Reslizumab in the Treatment of Poorly Controlled Asthma in Subjects With Eosinophilic Airway Inflammation

Resource links provided by NLM:

MedlinePlus related topics: Asthma

Drug Information available for: Reslizumab

U.S. FDA Resources

Further study details as provided by Ception Therapeutics:

Primary Outcome Measures:

Asthma Control Questionnaire [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Forced expiratory volume in the first second [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Number of asthma exacerbations [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]
Eosinophil levels [ Time Frame: 15 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	120
Study Start Date:	November 2007
Estimated Study Completion Date:	November 2009
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Reslizumab 3 mg/kg	Biological: Reslizumab IV (in the vein) on Day 0 of each 28 day cycle (+/- 7 days) Number of Cycles=4
2: Placebo Comparator Saline	Other: Saline IV (in the vein) on Day 0 of each 28 day cycle (+/-7 days) Number of Cycles=4

Detailed 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 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.

Eligibility

Ages Eligible for Study:	18 Years to 75 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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, 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 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-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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587288

Show 30 Study Locations

Sponsors and Collaborators

Ception Therapeutics

Investigators

Study Director:

H. Jeffrey Wilkins, M.D.

Ception Therapeutics

More Information

No publications provided

Responsible Party:	Ception Therapeutics ( H. Jeffrey Wilkins, M.D./ Senior Vice-President of Clinical Development )
Study ID Numbers:	Res-5-0010
Study First Received:	January 4, 2008
Last Updated:	May 1, 2009
ClinicalTrials.gov Identifier:	NCT00587288 History of Changes
Health Authority:	Canada: Health Canada; Canada: Ethics Review Committee; United States: Food and Drug Administration; United States: Institutional Review Board

Keywords provided by Ception Therapeutics:

Cinquil™
Reslizumab

Additional relevant MeSH terms:

Hypersensitivity
Lung Diseases, Obstructive
Immune System Diseases
Respiratory Tract Diseases
Bronchial Diseases

Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010