A Study of ARRY-502 in Patients With Persistent Asthma

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma
• Intervention / Treatment: Drug: Placebo; oral; Drug: ARRY-502, CRTh2 antagonist; oral

• Study Type: Interventional
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Pfizer
• Investigators: Study Director: Pfizer CT.gov Call Center, Pfizer

Study record dates

Study Major Dates

• Study Start (Actual): April 2, 2012
• Primary Completion (Actual): May 31, 2013
• Study Completion (Actual): June 10, 2013

Study Registration Dates

• First Submitted: March 21, 2012
• First Submitted That Met QC Criteria: March 21, 2012
• First Posted (Estimated): March 23, 2012

Study Record Updates

• Last Update Posted (Actual): October 30, 2023
• Last Update Submitted That Met QC Criteria: October 26, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: ARRAY-502-201; C4681001 (Other Identifier: Alias Study Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.