Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia

A Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel Group, 24-Week Phase II Study to Evaluate Efficacy and Safety of RDEA3170 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg Versus Placebo and Open-Label Allopurinol 200 mg as a Reference Arm in Japanese Patients With Gout or Asymptomatic Hyperuricemia

This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in greater reduction of sUA compared to placebo.

Study Overview

• Status: Completed
• Conditions: Gout and Hyperuricemia
• Intervention / Treatment: Drug: RDEA3170; Drug: Placebo; Drug: Allopurinol

• Study Type: Interventional
• Enrollment (Actual): 204
• Phase: Phase 2

Contacts and Locations

Study Locations

• Japan
  • Chofu-shi, Japan, 182-0006
    • Research Site
  • Fukuoka-shi, Japan, 812-0027
    • Research Site
  • Fukuoka-shi, Japan, 819-8551
    • Research Site
  • Fukuoka-shi, Japan, 819-0006
    • Research Site
  • Kitakyushu-shi, Japan, 807-0857
    • Research Site
  • Matsudo-shi, Japan, 270-0021
    • Research Site
  • Noda-shi, Japan, 278-8501
    • Research Site
  • Ota-ku, Japan, 144-0034
    • Research Site
  • Saitama-shi, Japan, 339-8521
    • Research Site
  • Sendai-shi, Japan, 981-0923
    • Research Site
  • Sendai-shi, Japan, 983-0039
    • Research Site
  • Sendai-shi, Japan, 983-0835
    • Research Site
  • Sendai-shi, Japan, 980-0011
    • Research Site
  • Shinagawa-ku, Japan, 141-6003
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subject meets any of the following criteria and with sUA ≤10.0 mg/dL:

  1. sUA level of >7.0 mg/dL at 7 days prior to baseline with gout;
  2. sUA level of ≥8.0 mg/dL at 7 days prior to baseline without gout but with complications (hypertension, ischemic heart disease, diabetes, metabolic syndrome);
  3. sUA level of ≥9.0 mg/dL at 7 days prior to baseline without gout and complications.

Exclusion Criteria:

• Subject with an acute gout flare that has not resolved at least 14 days prior to the baseline visit.
• Subject has a history or suspicion of kidney stones.
• Subject has an estimated creatinine clearance <60 mL/min calculated by the Cockcroft Gault formula
• Subject is receiving strong or moderate CYP3A inhibitors

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: RDEA3170 1; RDEA3170 5mg followed by RDEA3170 7.5mg	Drug: RDEA3170; Oral Treatment
EXPERIMENTAL: RDEA3170 2; RDEA3170 10mg followed by RDEA3170 12.5mg	Drug: RDEA3170; Oral Treatment
EXPERIMENTAL: RDEA3170 3; RDEA3170 12.5mg followed by RDEA3170 15mg	Drug: RDEA3170; Oral Treatment
PLACEBO_COMPARATOR: RDEA3170 4; RDEA3170 Placebo	Drug: Placebo; Oral Treatment
OTHER: Allopurinol; Allopurinol 200mg	Drug: Allopurinol; Oral Treatment; Other Names: Allopurinol 200mg Sawai

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percent Changes of Serum Uric Acid Levels From Baseline Levels	The primary objective of the study is to compare percent changes of serum uric acid levels from baseline levels after 16 weeks of dosing between RDEA3170 treatment groups and the placebo treatment group.	Baseline and Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Subjects With a Serum Uric Acid Level ≤6.0 mg/dL	To compare the percentage of subjects whose serum uric acid levels are ≤ 6.0 mg/dL between RDEA3170 treatment groups and the placebo treatment group at each study visit	Weeks 1,2,4,6,8,10,12,16,18,20,24
Percent Change in sUA	To compare percent change in sUA at each study visit.	Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24
Absolute Change of Serum Uric Acid Levels From Baseline Levels	To compare the absolute change of serum uric acid levels from baseline levels	Baseline, Weeks 1,2,4,6,8,10,12,16,18,20,24

Collaborators and Investigators

• Sponsor: AstraZeneca
• Collaborators: Ardea Biosciences, Inc.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 5, 2014
• Primary Completion (ACTUAL): March 13, 2015
• Study Completion (ACTUAL): March 13, 2015

Study Registration Dates

• First Submitted: February 26, 2014
• First Submitted That Met QC Criteria: March 4, 2014
• First Posted (ESTIMATE): March 5, 2014

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2019
• Last Update Submitted That Met QC Criteria: August 21, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Hyperuricemia; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Antirheumatic Agents; Antimetabolites; Protective Agents; Antioxidants; Free Radical Scavengers; Gout Suppressants; Allopurinol; Verinurad
• Other Study ID Numbers: D5491C00001; RDEA3170-203 (OTHER: Ardea Biosciences, Inc.)