A Study of ARRY-502 in Patients With Persistent Asthma
Status: | Completed |
---|---|
Conditions: | Asthma |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 18 - 70 |
Updated: | 3/30/2013 |
Start Date: | March 2012 |
End Date: | May 2013 |
Contact: | Array BioPharma Clinical Trial Call Center |
Phone: | 303-381-6604 |
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.
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.
We found this trial at
45
sites
6801 s Yosemite street
Southwest Arapahoe, Colorado 80112
Southwest Arapahoe, Colorado 80112
303-773-9000
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550 Deep Valley Drive Rolling Hills Estates
Palos Verdes, California 90274
Palos Verdes, California 90274
310-265-1623
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
918-392-4550
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