This is a Phase 2 study, involving a 12-week treatment period, designed to evaluate the effectiveness of investigational study drug ARRY-371797 (versus placebo) in treating ankylosing spondylitis, and to further evaluate the drug's safety. Approximately 130 patients from the US, Canada, Poland and Hungary will be enrolled in this study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
25
multiple dose, single schedule
matching placebo
multiple dose, single schedule
Cedars-Sinai Medical Center
Los Angeles, California, United States
Northwestern University
Chicago, Illinois, United States
Westroads Medical Group
Omaha, Nebraska, United States
Assess the efficacy of the study drug (versus placebo) in terms of Assessments in Ankylosing Spondylitis 20% Working Group response criterion (ASAS 20).
Time frame: 12 weeks
Characterize the safety profile of the study drug in terms of adverse events, clinical laboratory tests and electrocardiograms.
Time frame: 12 weeks
Characterize the pharmacokinetics (PK) of the study drug and a metabolite in terms of plasma concentrations.
Time frame: 12 weeks
Explore potential biomarkers for pharmacodynamics (PD).
Time frame: 12 weeks
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Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Oregon Health & Science University
Portland, Oregon, United States
Low Country Rheumatology
Charleston, South Carolina, United States
Arthritis Northwest
Spokane, Washington, United States
Rheumatology Research Associates Group
Edmonton, Alberta, Canada
University of Manitoba
Winnipeg, Manitoba, Canada
Credit Valley Rheumatology
Mississauga, Ontario, Canada
...and 2 more locations