A Study of ARRY-502 in Patients With Persistent Asthma

NCT ID: NCT01561690

Last Updated: 2023-10-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

184 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-04-02

Study Completion Date

2013-06-10

Brief Summary

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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

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ARRY-502

Group Type EXPERIMENTAL

ARRY-502, CRTh2 antagonist; oral

Intervention Type DRUG

multiple dose, single schedule

Placebo

Group Type PLACEBO_COMPARATOR

Placebo; oral

Intervention Type DRUG

matching placebo

Interventions

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ARRY-502, CRTh2 antagonist; oral

multiple dose, single schedule

Intervention Type DRUG

Placebo; oral

matching placebo

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

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Allergy & Asthma Specialists Medical Group

Huntington Beach, California, United States

Site Status

Allergy Medical Clinic - Research Division

Los Angeles, California, United States

Site Status

California Allergy & Asthma Med. Group

Los Angeles, California, United States

Site Status

Southern California Institute for Respiratory Diseases Inc

Los Angeles, California, United States

Site Status

Southern California Research

Mission Viejo, California, United States

Site Status

Peninsula Research Associates

Rolling Hills Estates, California, United States

Site Status

Allergy Associates Medical Group

San Diego, California, United States

Site Status

Colorado Allergy and Asthma Center

Centennial, Colorado, United States

Site Status

IMMUNOe International Research Centers

Centennial, Colorado, United States

Site Status

Asthma & Allergy Associates PC

Colorado Springs, Colorado, United States

Site Status

Rocky Mountain Center for Clinical Research

Wheat Ridge, Colorado, United States

Site Status

Clinical Neuroscience Solutions

Jacksonville, Florida, United States

Site Status

Pulmonary Disease Specialists

Kissimmee, Florida, United States

Site Status

South Florida Research Trials

Miami, Florida, United States

Site Status

Allergy & Asthma Diagnostic Treatment Center

Tallahassee, Florida, United States

Site Status

Florida Pulmonary Research Institute

Winter Park, Florida, United States

Site Status

Idaho Research

Eagle, Idaho, United States

Site Status

Sneeze, Wheeze & Itch

Normal, Illinois, United States

Site Status

Chesapeake Clinical Research Inc

Baltimore, Maryland, United States

Site Status

Northeast Medical Research Associates

North Dartmouth, Massachusetts, United States

Site Status

Clinical Research Institute

Minneapolis, Minnesota, United States

Site Status

Clinical Research Institute

Plymouth, Minnesota, United States

Site Status

Clinical Research Group of Montana

Bozeman, Montana, United States

Site Status

The Asthma & Allergy Center

Bellevue, Nebraska, United States

Site Status

Princeton Center for Clinical Research

Skillman, New Jersey, United States

Site Status

North Carolina Clinical Research

Raleigh, North Carolina, United States

Site Status

Allergy, Respiratory & Sleep Center

Canton, Ohio, United States

Site Status

Bernstein Clinical Research

Cincinnati, Ohio, United States

Site Status

Toledo Center for Clinical Research

Sylvania, Ohio, United States

Site Status

IPS Research Company

Oklahoma City, Oklahoma, United States

Site Status

Allergy Asthma & Clinical Research Center

Oklahoma City, Oklahoma, United States

Site Status

Vital Prospects Clinical Research Institute, PC

Tulsa, Oklahoma, United States

Site Status

Baker Allergy, Asthma & Dermatology Research Center

Lake Oswego, Oregon, United States

Site Status

Clinical Research Institute of Southern Oregon

Medford, Oregon, United States

Site Status

University of Pittsburgh Asthma Institute

Pittsburgh, Pennsylvania, United States

Site Status

Tekton Research

Austin, Texas, United States

Site Status

Pharmaceutical Research & Consulting Inc.

Dallas, Texas, United States

Site Status

Western Sky Medical Research Inc

El Paso, Texas, United States

Site Status

Central Texas Health Research

New Braunfels, Texas, United States

Site Status

Sylvana Research Associates

San Antonio, Texas, United States

Site Status

Asthma Inc.

Seattle, Washington, United States

Site Status

Allergy Asthma & Sinus Center, S.C.

Greenfield, Wisconsin, United States

Site Status

Asthma Allergy & Pulmonary Research

Madison, Wisconsin, United States

Site Status

Countries

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United States

Other Identifiers

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C4681001

Identifier Type: OTHER

Identifier Source: secondary_id

ARRAY-502-201

Identifier Type: -

Identifier Source: org_study_id

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