Trial record 1 of 48 for:    502-201
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A Study of ARRY-502 in Patients With Persistent Asthma

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Array BioPharma
ClinicalTrials.gov Identifier:
NCT01561690
First received: March 21, 2012
Last updated: June 6, 2013
Last verified: June 2013

March 21, 2012
June 6, 2013
March 2012
May 2013   (final data collection date for primary outcome measure)
Assess the efficacy of the study drug (versus placebo) in terms of prebronchodilator forced expiratory volume in 1 second (FEV1). [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01561690 on ClinicalTrials.gov Archive Site
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Measure the exposure of study drug in terms of plasma concentrations. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests, vital signs and electrocardiograms. [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]
  • Measure the exposure of study drug in terms of plasma concentrations. [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  • Assess the effect of study drug on asthma control in terms of Asthma Control Questionnaire-6 (ACQ-6) 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of ARRY-502 in Patients With Persistent Asthma
Not Provided

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Asthma
  • Drug: ARRY-502, CRTh2 antagonist; oral
    multiple dose, single schedule
  • Drug: Placebo; oral
    matching placebo
  • Experimental: ARRY-502
    Intervention: Drug: ARRY-502, CRTh2 antagonist; oral
  • Placebo Comparator: Placebo
    Intervention: Drug: Placebo; oral
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
184
May 2013
May 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01561690
ARRAY-502-201
No
Array BioPharma
Array BioPharma
Not Provided
Not Provided
Array BioPharma
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP