A Study of ARRY-502 in Patients With Persistent Asthma

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Array BioPharma

ClinicalTrials.gov Identifier:

NCT01561690

First received: March 21, 2012

Last updated: April 23, 2013

Last verified: April 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	March 21, 2012
Last Updated Date	April 23, 2013
Start Date ^ICMJE	March 2012
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 21, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01561690 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: July 24, 2012)	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 ]
Original Secondary Outcome Measures ^ICMJE (submitted: March 21, 2012)	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-6 (ACQ-6) 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 ]
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study of ARRY-502 in Patients With Persistent Asthma
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Condition ^ICMJE	Asthma
Intervention ^ICMJE	Drug: ARRY-502, CRTh2 antagonist; oral multiple dose, single schedule Drug: Placebo; oral matching placebo
Study Arm (s)	Experimental: ARRY-502 Intervention: Drug: ARRY-502, CRTh2 antagonist; oral Placebo Comparator: Placebo Intervention: Drug: Placebo; oral
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	182
Estimated Completion Date	May 2013
Estimated Primary Completion Date	May 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01561690
Other Study ID Numbers ^ICMJE	ARRAY-502-201
Has Data Monitoring Committee	No
Responsible Party	Array BioPharma
Study Sponsor ^ICMJE	Array BioPharma
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Array BioPharma
Verification Date	April 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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