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A Study of ARRY-502 in Patients With Persistent Asthma

Primary Purpose

Asthma

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
ARRY-502, CRTh2 antagonist; oral
Placebo; oral
Sponsored by
Array BioPharma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Allergy & Asthma Specialists Medical Group
  • Allergy Medical Clinic - Research Division
  • California Allergy & Asthma Med. Group
  • Southern California Institute for Respiratory Diseases Inc
  • Southern California Research
  • Peninsula Research Associates
  • Allergy Associates Medical Group
  • Colorado Allergy and Asthma Center
  • IMMUNOe International Research Centers
  • Asthma & Allergy Associates PC
  • Rocky Mountain Center for Clinical Research
  • Clinical Neuroscience Solutions
  • Pulmonary Disease Specialists
  • South Florida Research Trials
  • Allergy & Asthma Diagnostic Treatment Center
  • Florida Pulmonary Research Institute
  • Idaho Research
  • Sneeze, Wheeze & Itch
  • Chesapeake Clinical Research Inc
  • Northeast Medical Research Associates
  • Clinical Research Institute
  • Clinical Research Institute
  • Clinical Research Group of Montana
  • The Asthma & Allergy Center
  • Princeton Center for Clinical Research
  • North Carolina Clinical Research
  • Allergy, Respiratory & Sleep Center
  • Bernstein Clinical Research
  • Toledo Center for Clinical Research
  • IPS Research Company
  • Allergy Asthma & Clinical Research Center
  • Vital Prospects Clinical Research Institute, PC
  • Baker Allergy, Asthma & Dermatology Research Center
  • Clinical Research Institute of Southern Oregon
  • University of Pittsburgh Asthma Institute
  • Tekton Research
  • Pharmaceutical Research & Consulting Inc.
  • Western Sky Medical Research Inc
  • Central Texas Health Research
  • Sylvana Research Associates
  • Asthma Inc.
  • Allergy Asthma & Sinus Center, S.C.
  • Asthma Allergy & Pulmonary Research

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

ARRY-502

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).

Secondary Outcome Measures

Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Measure the exposure of study drug in terms of plasma concentrations.
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.
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).

Full Information

First Posted
March 21, 2012
Last Updated
June 6, 2013
Sponsor
Array BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT01561690
Brief Title
A Study of ARRY-502 in Patients With Persistent Asthma
Study Type
Interventional

2. Study Status

Record Verification Date
June 2013
Overall Recruitment Status
Completed
Study Start Date
March 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Array BioPharma

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
184 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ARRY-502
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
ARRY-502, CRTh2 antagonist; oral
Intervention Description
multiple dose, single schedule
Intervention Type
Drug
Intervention Name(s)
Placebo; oral
Intervention Description
matching placebo
Primary Outcome Measure Information:
Title
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1).
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms.
Time Frame
6 weeks
Title
Measure the exposure of study drug in terms of plasma concentrations.
Time Frame
6 weeks
Title
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
Title
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Allergy & Asthma Specialists Medical Group
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Allergy Medical Clinic - Research Division
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
California Allergy & Asthma Med. Group
City
Los Angeles
State/Province
California
ZIP/Postal Code
90025
Country
United States
Facility Name
Southern California Institute for Respiratory Diseases Inc
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Southern California Research
City
Mission Viejo
State/Province
California
ZIP/Postal Code
92691
Country
United States
Facility Name
Peninsula Research Associates
City
Rolling Hills Estates
State/Province
California
ZIP/Postal Code
90274
Country
United States
Facility Name
Allergy Associates Medical Group
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Colorado Allergy and Asthma Center
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
IMMUNOe International Research Centers
City
Centennial
State/Province
Colorado
ZIP/Postal Code
80112
Country
United States
Facility Name
Asthma & Allergy Associates PC
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
Rocky Mountain Center for Clinical Research
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Clinical Neuroscience Solutions
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32256
Country
United States
Facility Name
Pulmonary Disease Specialists
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
South Florida Research Trials
City
Miami
State/Province
Florida
ZIP/Postal Code
33186
Country
United States
Facility Name
Allergy & Asthma Diagnostic Treatment Center
City
Tallahassee
State/Province
Florida
ZIP/Postal Code
32308
Country
United States
Facility Name
Florida Pulmonary Research Institute
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Idaho Research
City
Eagle
State/Province
Idaho
ZIP/Postal Code
83616
Country
United States
Facility Name
Sneeze, Wheeze & Itch
City
Normal
State/Province
Illinois
ZIP/Postal Code
61761
Country
United States
Facility Name
Chesapeake Clinical Research Inc
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21236
Country
United States
Facility Name
Northeast Medical Research Associates
City
North Dartmouth
State/Province
Massachusetts
ZIP/Postal Code
02747
Country
United States
Facility Name
Clinical Research Institute
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55402
Country
United States
Facility Name
Clinical Research Institute
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55441
Country
United States
Facility Name
Clinical Research Group of Montana
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
The Asthma & Allergy Center
City
Bellevue
State/Province
Nebraska
ZIP/Postal Code
68123
Country
United States
Facility Name
Princeton Center for Clinical Research
City
Skillman
State/Province
New Jersey
ZIP/Postal Code
08558
Country
United States
Facility Name
North Carolina Clinical Research
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Allergy, Respiratory & Sleep Center
City
Canton
State/Province
Ohio
ZIP/Postal Code
44718
Country
United States
Facility Name
Bernstein Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
Facility Name
Toledo Center for Clinical Research
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
IPS Research Company
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73103
Country
United States
Facility Name
Allergy Asthma & Clinical Research Center
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73120
Country
United States
Facility Name
Vital Prospects Clinical Research Institute, PC
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74136
Country
United States
Facility Name
Baker Allergy, Asthma & Dermatology Research Center
City
Lake Oswego
State/Province
Oregon
ZIP/Postal Code
97035
Country
United States
Facility Name
Clinical Research Institute of Southern Oregon
City
Medford
State/Province
Oregon
ZIP/Postal Code
97504
Country
United States
Facility Name
University of Pittsburgh Asthma Institute
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Tekton Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78745
Country
United States
Facility Name
Pharmaceutical Research & Consulting Inc.
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Western Sky Medical Research Inc
City
El Paso
State/Province
Texas
ZIP/Postal Code
79903
Country
United States
Facility Name
Central Texas Health Research
City
New Braunfels
State/Province
Texas
ZIP/Postal Code
78130
Country
United States
Facility Name
Sylvana Research Associates
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Asthma Inc.
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
Allergy Asthma & Sinus Center, S.C.
City
Greenfield
State/Province
Wisconsin
ZIP/Postal Code
53228
Country
United States
Facility Name
Asthma Allergy & Pulmonary Research
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53792
Country
United States

12. IPD Sharing Statement

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A Study of ARRY-502 in Patients With Persistent Asthma

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