RDEA3170 Monotherapy in Subjects With Gout

NCT01927198 | Completed Phase 2

• 1 other identifier: RDEA3170-201
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 49

Brief Summary

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.

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

• Efficacy of RDEA3170 monotherapy at Week 12

  Percent change from baseline in serum urate levels at Week 12.

  Week 12

Secondary Outcomes (2)

• Incidence of treatment-emergent adverse events and change from baseline in laboratory values, vital signs, and electrocardiograms

  8 months

• Efficacy of RDEA3170 monotherapy at Week 24

  Week 24

Study Arms (4)

RDEA3170 5 mg qd

EXPERIMENTAL

No titration.

Drug: RDEA3170 5 mg

RDEA3170 10 mg qd

EXPERIMENTAL

Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.

Drug: RDEA3170 10 mg

RDEA3170 12.5 mg qd

EXPERIMENTAL

Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.

Drug: RDEA3170 12.5 mg

Placebo

PLACEBO COMPARATOR

Placebo group

Drug: Placebo

Interventions

Placebo DRUG

Placebo

RDEA3170 5 mg DRUG

RDEA3170 5 mg qd

RDEA3170 10 mg DRUG

RDEA3170 10 mg qd

RDEA3170 12.5 mg DRUG

RDEA3170 12.5 mg qd

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject meets the diagnosis of gout per the American Rheumatism Association Criteria for the Classification of Acute Arthritis of Primary Gout.
• Subject has a serum urate level ≥ 6.5 mg/dL and ≤ 10.0 mg/dL during the Screening Period.
• Subject has a body mass index \< 40 kg/m2.

You may not qualify if:

• Subject is pregnant or breastfeeding. Subject consumes more than 14 drinks of alcohol per week (eg, 1 drink = 5 oz \[150 mL\] of wine, 12 oz \[360 mL\] of beer, or 1.5 oz \[45 mL\] of hard liquor).
• Subject has a history or suspicion of kidney stones.
• Subject has a history or suspicion of drug abuse within the past 5 years.
• Subject has a history of symptomatic myositis/myopathy or rhabdomyolysis.
• Subject has a known or suspected human immunodeficiency virus infection.
• Subject has a positive test for active hepatitis B or hepatitis C infection.
• Subject has a history of malignancy within the previous 5 years with the exception of non-melanoma skin cancer that has been treated with no evidence of recurrence, treated cervical dysplasia, or treated in situ Grade 1 cervical cancer.
• Subject within the last 12 months with: unstable angina, New York Heart Association class III or IV heart failure, myocardial infarction, stroke, or deep venous thrombosis; or subjects currently receiving anticoagulants.
• Subject has a QT interval corrected for heart rate according to Fridericia's formula \> 450 msec during the Screening Period, confirmed by a repeat assessment.
• Subject has uncontrolled hypertension.
• Subject has an estimated creatinine clearance \< 60 mL/min.
• Subject has an alkaline phosphatase \> 2.0 x upper limit of normal during the Screening Period.
• Subject has active liver disease or impaired hepatic function.
• Subject is receiving chronic treatment with more than 325 mg salicylates per day.
• Subject has a medical condition that requires or may require systemic immunosuppressive (eg, chronic low-dose oral prednisone) or immunomodulatory treatment.

Sponsors & Collaborators

• Ardea Biosciences, Inc.: lead

Study Sites (49)

Unknown Facility

Birmingham, Alabama, 35235, United States

Location

Unknown Facility

Gulf Shores, Alabama, 36542, United States

Location

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Mobile, Alabama, 36608, United States

Location

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Glendale, Arizona, 85308, United States

Location

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Peoria, Arizona, 85381, United States

Location

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Tucson, Arizona, 85704, United States

Location

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Anaheim, California, 92805, United States

Location

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Gold River, California, 95670, United States

Location

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Irvine, California, 92618, United States

Location

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San Leandro, California, 94578, United States

Location

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San Ramon, California, 94582, United States

Location

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Colorado Springs, Colorado, 80918, United States

Location

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Denver, Colorado, 80220, United States

Location

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Jacksonville, Florida, 32205, United States

Location

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Pembroke Pines, Florida, 33027, United States

Location

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Tampa, Florida, 33606, United States

Location

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Winter Haven, Florida, 33880, United States

Location

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Dunwoody, Georgia, 30338, United States

Location

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Honolulu, Hawaii, 96814, United States

Location

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Meridian, Idaho, 83646, United States

Location

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Gurnee, Illinois, 60031, United States

Location

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Elizabethtown, Kentucky, 42701, United States

Location

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Lexington, Kentucky, 40503, United States

Location

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Metairie, Louisiana, 70006, United States

Location

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Jackson, Mississippi, 39202, United States

Location

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Reno, Nevada, 89502, United States

Location

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New York, New York, 10016, United States

Location

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Charlotte, North Carolina, 28210, United States

Location

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Hickory, North Carolina, 28602, United States

Location

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Shelby, North Carolina, 28150, United States

Location

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Shelby, North Carolina, 28152, United States

Location

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Wilmington, North Carolina, 28401, United States

Location

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Winston-Salem, North Carolina, 27103, United States

Location

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Fargo, North Dakota, 58103, United States

Location

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Cincinnati, Ohio, 45224, United States

Location

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Perrysburg, Ohio, 43551, United States

Location

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Willoughby Hills, Ohio, 44904, United States

Location

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Altoona, Pennsylvania, 16602, United States

Location

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Greenville, South Carolina, 29615, United States

Location

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Greer, South Carolina, 29651, United States

Location

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Mt. Pleasant, South Carolina, 29464, United States

Location

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Rock Hill, South Carolina, 29732, United States

Location

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Spartanburg, South Carolina, 29303, United States

Location

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Spring Hill, Tennessee, 37174, United States

Location

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Houston, Texas, 77098, United States

Location

Unknown Facility

Bountiful, Utah, 84010, United States

Location

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Midlothian, Virginia, 23114, United States

Location

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Richmond, Virginia, 23219, United States

Location

Unknown Facility

Virginia Beach, Virginia, 23462, United States

Location

MeSH Terms

Conditions

Gout

Interventions

verinurad

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• J. Hall, MD

  Ardea Biosciences, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 20, 2013
• First Posted: August 22, 2013
• Study Start: August 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: July 1, 2014
• Last Updated: July 1, 2015

Record last verified: 2015-06

Locations

US (49)