A Study of ARRY-502 in Patients With Persistent Asthma

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Array BioPharma

ClinicalTrials.gov Identifier:

NCT01561690

First received: March 21, 2012

Last updated: June 6, 2013

Last verified: June 2013

History of Changes

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 ]

Enrollment:	184
Study Start Date:	March 2012
Study Completion Date:	May 2013
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

Show 43 Study Locations

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:	June 6, 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 June 18, 2013

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