This study will assess the serum uric acid lowering effects and safety of 3 dose levels of RDEA3170 compared to placebo in subjects with gout.
This monotherapy study is the initial Phase 2 study for RDEA3170 and is designed to compare the safety and efficacy of multiple dose levels of RDEA3170 with placebo when given for up to 24 weeks to subjects with gout. The placebo control for RDEA3170 is included in this study to minimize bias in study assessments and monitoring. Further, to accomplish the goal of understanding the safety profile of RDEA3170, it is important to compare RDEA3170 monotherapy with placebo for at least 24 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
172
Efficacy of RDEA3170 monotherapy at Week 12
Percent change from baseline in serum urate levels at Week 12.
Time frame: Week 12
Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms
Safety assessments include adverse event (AE) recording, gout flare recording, clinical safety laboratory tests (eg, hematology, serum chemistry, and urinalysis), physical examinations, vital sign measurements, and ECGs.
Time frame: 8 months
Efficacy of RDEA3170 monotherapy at Week 24
Percent change from baseline in serum urate levels at each visit. Proportion of subjects with a serum urate level \< 6.0 and \< 5.0 mg/dL at each visit.
Time frame: Week 24
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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Birmingham, Alabama, United States
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Gulf Shores, Alabama, United States
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Mobile, Alabama, United States
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Glendale, Arizona, United States
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Peoria, Arizona, United States
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Tucson, Arizona, United States
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Anaheim, California, United States
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Gold River, California, United States
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Irvine, California, United States
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San Leandro, California, United States
...and 39 more locations