A Study of ARRY-502 in Patients With Persistent Asthma

Study Overview
=================
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.

Official Title
-----------------
A Phase 2 Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of ARRY-502 in Adults With Persistent Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: ARRY-502, CRTh2 antagonist; oral
* Drug: Placebo; oral


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARRY-502<br> | Drug: ARRY-502, CRTh2 antagonist; oral<br>* multiple dose, single schedule<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo; oral<br>* matching placebo<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1). |  | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. |  | 6 weeks | 
| Measure the exposure of study drug in terms of plasma concentrations. |  | 6 weeks | 
| 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. |  | 6 weeks | 
| 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). |  | 6 weeks |