A Study of ARRY-502 in Patients With Persistent Asthma - Full Text View

Purpose

This is a Phase 2 study, involving a 6-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-502 in treating mild to moderate persistent asthma, and to further evaluate the safety of the drug. Approximately 180 patients from the US will be enrolled in this study.

Condition	Intervention	Phase
Asthma	Drug: ARRY-502, CRTh2 antagonist; oral Drug: Placebo; oral	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment

Resource links provided by NLM:

MedlinePlus related topics: Asthma

U.S. FDA Resources

Further study details as provided by Array BioPharma:

Primary Outcome Measures:

Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
Measure the exposure of study drug in terms of plasma concentrations. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire (ACQ) score, the number of symptom-free days and the number of weekly short-acting beta (ß) 2 agonist (SABA) metered dose inhaler (MDI) actuations. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Assess the effect of study drug on respiratory function in terms of FEV1, forced vital capacity (FVC), forced expiratory flow (FEF) and peak expiratory flow (PEF). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	182
Study Start Date:	March 2012
Estimated Study Completion Date:	May 2013
Estimated Primary Completion Date:	May 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: ARRY-502	Drug: ARRY-502, CRTh2 antagonist; oral multiple dose, single schedule
Placebo Comparator: Placebo	Drug: Placebo; oral matching placebo

Eligibility

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Key Inclusion Criteria:

Documented history of bronchial asthma diagnosed at least 6 months prior to study start and prior to the age of 40 years.
Body mass index (BMI) of 18 to 35 inclusive.
An ACQ score of ≥ 1.5 at specified time points prior to first dose of study drug.
A best prebronchodilator FEV1 of 60% to 85% of the predicted normal value and a change in best postbronchodilator FEV1 of ≥ 12% and ≥ 200 mL at specified time points prior to first dose of study drug.
Additional criteria exist.

Key Exclusion Criteria:

Evidence of aspirin-sensitive asthma.
Pre-existing lung disease other than asthma.
Clinically significant dermatologic, hematological, renal, endocrine, pulmonary (other than asthma), gastrointestinal, cardiovascular, hepatic, neurologic, ophthalmologic, musculoskeletal or immunologic disease (excepting allergic disease and asthma) that is uncontrolled despite treatment or is likely in the opinion of the Investigator to require a change in therapy during the study.
Patients with any current or past history of cancer within 5 years prior to study start except for treated basal cell or squamous cell carcinomas of the skin, ductal carcinoma in situ of the breast or cervical carcinomas in situ.
Any history of serious illness requiring hospitalization within 6 months prior to study start.
Known positive serology for the human immunodeficiency virus (HIV), hepatitis B and/or active hepatitis C.
A positive test for drugs or alcohol, unless the positive drug screen is associated with a prescribed medication and is approved by the Medical Monitor.
Smoking (tobacco or marijuana) within 6 months prior to study start and/or a smoking history of > 10 packs/year.
Blood donation of ≥ 1 pint (473 mL) within 8 weeks prior to the first dose of study drug.
Previous treatment with ARRY-502.
Additional criteria exist.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01561690

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Locations

United States, California
Allergy & Asthma Specialists Medical Group
Huntington Beach, California, United States, 92647
Allergy Medical Clinic - Research Division
Los Angeles, California, United States, 90025
California Allergy & Asthma Med. Group
Los Angeles, California, United States, 90025
Southern California Institute for Respiratory Diseases Inc
Los Angeles, California, United States, 90048
Southern California Research
Mission Viejo, California, United States, 92691
Peninsula Research Associates
Rolling Hills Estates, California, United States, 90274
Allergy Associates Medical Group
San Diego, California, United States, 92120
United States, Colorado
Colorado Allergy and Asthma Center
Centennial, Colorado, United States, 80112
IMMUNOe International Research Centers
Centennial, Colorado, United States, 80112
Asthma & Allergy Associates PC
Colorado Springs, Colorado, United States, 80909
Rocky Mountain Center for Clinical Research
Wheat Ridge, Colorado, United States, 80033
United States, Florida
Clinical Neuroscience Solutions
Jacksonville, Florida, United States, 32256
Pulmonary Disease Specialists
Kissimmee, Florida, United States, 34741
South Florida Research Trials
Miami, Florida, United States, 33186
Allergy & Asthma Diagnostic Treatment Center
Tallahassee, Florida, United States, 32308
Florida Pulmonary Research Institute
Winter Park, Florida, United States, 32789
United States, Idaho
Idaho Research
Eagle, Idaho, United States, 83616
United States, Illinois
Sneeze, Wheeze & Itch
Normal, Illinois, United States, 61761
United States, Maryland
Chesapeake Clinical Research Inc
Baltimore, Maryland, United States, 21236
United States, Massachusetts
Northeast Medical Research Associates
North Dartmouth, Massachusetts, United States, 02747
United States, Minnesota
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Clinical Research Institute
Plymouth, Minnesota, United States, 55441
United States, Montana
Clinical Research Group of Montana
Bozeman, Montana, United States, 59718
United States, Nebraska
The Asthma & Allergy Center
Bellevue, Nebraska, United States, 68123
United States, New Jersey
Princeton Center for Clinical Research
Skillman, New Jersey, United States, 08558
United States, North Carolina
North Carolina Clinical Research
Raleigh, North Carolina, United States, 27607
United States, Ohio
Allergy, Respiratory & Sleep Center
Canton, Ohio, United States, 44718
Bernstein Clinical Research
Cincinnati, Ohio, United States, 45231
Toledo Center for Clinical Research
Sylvania, Ohio, United States, 43560
United States, Oklahoma
Allergy Asthma & Clinical Research Center
Oklahoma City, Oklahoma, United States, 73120
IPS Research Company
Oklahoma City, Oklahoma, United States, 73103
Vital Prospects Clinical Research Institute, PC
Tulsa, Oklahoma, United States, 74136
United States, Oregon
Baker Allergy, Asthma & Dermatology Research Center
Lake Oswego, Oregon, United States, 97035
Clinical Research Institute of Southern Oregon
Medford, Oregon, United States, 97504
United States, Pennsylvania
University of Pittsburgh Asthma Institute
Pittsburgh, Pennsylvania, United States, 15213
United States, Texas
Tekton Research
Austin, Texas, United States, 78745
Pharmaceutical Research & Consulting Inc.
Dallas, Texas, United States, 75231
Western Sky Medical Research Inc
El Paso, Texas, United States, 79903
Central Texas Health Research
New Braunfels, Texas, United States, 78130
Sylvana Research Associates
San Antonio, Texas, United States, 78229
United States, Washington
Asthma Inc.
Seattle, Washington, United States, 98105
United States, Wisconsin
Allergy Asthma & Sinus Center, S.C.
Greenfield, Wisconsin, United States, 53228
Asthma Allergy & Pulmonary Research
Madison, Wisconsin, United States, 53792

Sponsors and Collaborators

Array BioPharma

More Information

No publications provided

Responsible Party:	Array BioPharma
ClinicalTrials.gov Identifier:	NCT01561690 History of Changes
Other Study ID Numbers:	ARRAY-502-201
Study First Received:	March 21, 2012
Last Updated:	April 23, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases

Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013