RDEA3170 Monotherapy in Subjects With Gout

A Phase 2, Randomized, Double-Blind, Multicenter, Placebo-Controlled Study to Evaluate the Efficacy and Safety of RDEA3170 Monotherapy in Subjects With Gout

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.

Study Overview

• Status: Completed
• Conditions: Gout
• Intervention / Treatment: Drug: Placebo; Drug: RDEA3170 10 mg; Drug: RDEA3170 5 mg; Drug: RDEA3170 12.5 mg

Detailed Description

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
• Enrollment (Actual): 172
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35235
    • Gulf Shores, Alabama, United States, 36542
    • Mobile, Alabama, United States, 36608
  • Arizona
    • Glendale, Arizona, United States, 85308
    • Peoria, Arizona, United States, 85381
    • Tucson, Arizona, United States, 85704
  • California
    • Anaheim, California, United States, 92805
    • Gold River, California, United States, 95670
    • Irvine, California, United States, 92618
    • San Leandro, California, United States, 94578
    • San Ramon, California, United States, 94582
  • Colorado
    • Colorado Springs, Colorado, United States, 80918
    • Denver, Colorado, United States, 80220
  • Florida
    • Jacksonville, Florida, United States, 32205
    • Pembroke Pines, Florida, United States, 33027
    • Tampa, Florida, United States, 33606
    • Winter Haven, Florida, United States, 33880
  • Georgia
    • Dunwoody, Georgia, United States, 30338
  • Hawaii
    • Honolulu, Hawaii, United States, 96814
  • Idaho
    • Meridian, Idaho, United States, 83646
  • Illinois
    • Gurnee, Illinois, United States, 60031
  • Kentucky
    • Elizabethtown, Kentucky, United States, 42701
    • Lexington, Kentucky, United States, 40503
  • Louisiana
    • Metairie, Louisiana, United States, 70006
  • Mississippi
    • Jackson, Mississippi, United States, 39202
  • Nevada
    • Reno, Nevada, United States, 89502
  • New York
    • New York, New York, United States, 10016
  • North Carolina
    • Charlotte, North Carolina, United States, 28210
    • Hickory, North Carolina, United States, 28602
    • Shelby, North Carolina, United States, 28150
    • Shelby, North Carolina, United States, 28152
    • Wilmington, North Carolina, United States, 28401
    • Winston-Salem, North Carolina, United States, 27103
  • North Dakota
    • Fargo, North Dakota, United States, 58103
  • Ohio
    • Cincinnati, Ohio, United States, 45224
    • Perrysburg, Ohio, United States, 43551
    • Perrysburgh, Ohio, United States, 43551
    • Willoughby Hills, Ohio, United States, 44904
  • Pennsylvania
    • Altoona, Pennsylvania, United States, 16602
  • South Carolina
    • Greenville, South Carolina, United States, 29615
    • Greer, South Carolina, United States, 29651
    • Mount Pleasant, South Carolina, United States, 29464
    • Rock Hill, South Carolina, United States, 29732
    • Spartanburg, South Carolina, United States, 29303
  • Tennessee
    • Spring Hill, Tennessee, United States, 37174
  • Texas
    • Houston, Texas, United States, 77098
  • Utah
    • Bountiful, Utah, United States, 84010
  • Virginia
    • Midlothian, Virginia, United States, 23114
    • Richmond, Virginia, United States, 23219
    • Virginia Beach, Virginia, United States, 23462

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Subject is unable to take colchicine for gout flare prophylaxis.
• Subject is receiving strong or moderate CYP3A inhibitors, p-glycoprotein inhibitors, or digoxin.
• Subject received any strong enzyme- inducing drug or product (eg, rifampin, rifabutin, phenytoin, phenobarbital, St. John's Wort) within 2 months prior to Day 1 or refuses to refrain from taking these medications until the end of the study.
• Subject received an investigational therapy within 30 days or 5 half-lives (whichever is longer) prior to the Screening Period.
• Subject has any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, might create undue risk to the subject or interfere with the subject's ability to comply with the protocol requirements, or to complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo; Placebo group	Drug: Placebo
Experimental: RDEA3170 5 mg qd; No titration.	Drug: RDEA3170 5 mg
Experimental: RDEA3170 10 mg qd; Increase from RDEA3170 5 mg to RDEA3170 10 mg qd at Week 2.	Drug: RDEA3170 10 mg
Experimental: RDEA3170 12.5 mg qd; Increase from RDEA3170 10 mg to RDEA3170 12.5 mg qd at Week 4.	Drug: RDEA3170 12.5 mg

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Efficacy of RDEA3170 monotherapy at Week 12	Percent change from baseline in serum urate levels at Week 12.	Week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	Week 24

Collaborators and Investigators

• Sponsor: Ardea Biosciences, Inc.
• Investigators: Study Director: J. Hall, MD, Ardea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start: August 1, 2013
• Primary Completion (Actual): May 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: August 20, 2013
• First Submitted That Met QC Criteria: August 20, 2013
• First Posted (Estimate): August 22, 2013

Study Record Updates

• Last Update Posted (Estimate): July 1, 2015
• Last Update Submitted That Met QC Criteria: June 4, 2015
• Last Verified: June 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Antirheumatic Agents; Gout Suppressants; Verinurad
• Other Study ID Numbers: RDEA3170-201