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A Study of ARRY-502 in Patients With Persistent Asthma | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

NCT01561690•Pfizer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - 70 years

Sex

ALL

Healthy Volunteers

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.
+1 more criteria

Locations (43)

Allergy & Asthma Specialists Medical Group

Huntington Beach, California, United States

Allergy Medical Clinic - Research Division

Los Angeles, California, United States

California Allergy & Asthma Med. Group

Los Angeles, California, United States

Southern California Institute for Respiratory Diseases Inc

Los Angeles, California, United States

Southern California Research

Mission Viejo, California, United States

Peninsula Research Associates

Rolling Hills Estates, California, United States

Allergy Associates Medical Group

San Diego, California, United States

Colorado Allergy and Asthma Center

Centennial, Colorado, United States

IMMUNOe International Research Centers

Centennial, Colorado, United States

Asthma & Allergy Associates PC

Colorado Springs, Colorado, United States

Key Dates

Start Date

April 2, 2012

Primary Completion Date

May 31, 2013

Completion Date

June 10, 2013

Last Updated

October 30, 2023

Enrollment

184

ACTUAL participants

Conditions

Asthma

Interventions

ARRY-502, CRTh2 antagonist; oral

DRUG

Placebo; oral

DRUG

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RECRUITING

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 30, 2023Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of ARRY-502 in Patients With Persistent Asthma

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate Brenipatide Compared With Placebo in Adult Participants With Uncontrolled Moderate to Severe Asthma

NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)

Blood Eosinophil Guided Versus Usual Care In The Management Of Mild To Moderate Asthma at Primary Care (BEAM)

Relationship of Airway Microbiota, Endotype and Phenotype in Adult Asthma

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