Gout
Conditions
Keywords
Gout
Brief summary
This study will assess the serum uric acid lowering effects and safety of lesinurad in combination with febuxostat over a long-term timeframe.
Detailed description
This is a Phase 3 extension study to assess the long-term efficacy and safety of lesinurad in combination with febuxostat in subjects who completed the double-blind treatment period in Study RDEA594-304.
Interventions
DRUGlesinurad
Tablets, 400 mg once daily (QD)
DRUGfebuxostat
Tabletsm 80 mg QD
Sponsors
Ardea Biosciences, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Subject is able to understand the study procedures and the risks involved and is willing to provide written informed consent before the first study related activity. * Subject completed the double-blind treatment period in Study RDEA594-304 and was actively receiving and tolerating study medication (lesinurad or placebo) and febuxostat 80 mg at the Month 12 visit. * Subject is male or female; female subjects of childbearing potential must agree to use an effective non-hormonal method of birth control during the study and for at least 14 days after the last dose of study medication.
Exclusion criteria
* Subject has any medical or psychological condition, which in the opinion of the Investigator and/or the 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With an sUA Level That is < 5.0 mg/dL | Up to approximately 2.5 years (at Extension Month 12) | Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus | Up to approximatley 2.5 years (at Extension Month 12) | Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases) |
Countries
Australia, Canada, New Zealand, Poland, Switzerland, United States
Participant flow
Recruitment details
Subjects entered this extension Study RDEA594-307 while the core Study RDEA594-304 was ongoing and the database was not yet locked. To maintain the blind of the core study for subjects entering the extension, the lesinurad dose for all subjects in this extension study was blinded to the Sponsor until database lock of Study RDEA594-304.
Pre-assignment details
Subjects randomized to lesinurad (RDEA594) 200 mg or 400 mg + febuxostat (FBX) 80 mg in Study RDEA594-304 continued to receive the same dose in this study. Subjects randomized to placebo + febuxostat 80 mg in Study RDEA594-304 were randomized in a double-blind, 1:1 fashion to either lesinurad 200 mg or 400 mg + febuxostat 80 mg.
Participants by arm
| Arm | Count |
|---|---|
| Lesinurad 400 mg + Febuxostat 80 mg | 99 |
| Lesinurad 200 mg + Febuxostat 80 mg | 97 |
| Total | 196 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 11 | 15 |
| Overall Study | Death | 1 | 0 |
| Overall Study | Gout flare | 0 | 1 |
| Overall Study | Lost to Follow-up | 6 | 3 |
| Overall Study | Protocol Violation | 6 | 6 |
| Overall Study | Withdrawal by Subject | 16 | 23 |
Baseline characteristics
| Characteristic | Lesinurad 400 mg + Febuxostat 80 mg | Lesinurad 200 mg + Febuxostat 80 mg | Total |
|---|---|---|---|
| Age, Continuous | 52.1 Years STANDARD_DEVIATION 10.58 | 52.9 Years STANDARD_DEVIATION 10.24 | 52.5 Years STANDARD_DEVIATION 10.41 |
| Age, Customized < 65 years | 88 Participants | 87 Participants | 175 Participants |
| Age, Customized >=65 years | 11 Participants | 10 Participants | 21 Participants |
| Region of Enrollment Australia | 5 Participants | 3 Participants | 8 Participants |
| Region of Enrollment Canada | 2 Participants | 6 Participants | 8 Participants |
| Region of Enrollment New Zealand | 7 Participants | 3 Participants | 10 Participants |
| Region of Enrollment Poland | 12 Participants | 13 Participants | 25 Participants |
| Region of Enrollment Switzerland | 1 Participants | 0 Participants | 1 Participants |
| Region of Enrollment United States | 72 Participants | 72 Participants | 144 Participants |
| Sex/Gender, Customized Female | 92 Participant | 96 Participant | 188 Participant |
| Sex/Gender, Customized Male | 7 Participant | 1 Participant | 8 Participant |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 97 | 0 / 99 |
| other Total, other adverse events | 61 / 97 | 70 / 99 |
| serious Total, serious adverse events | 16 / 97 | 19 / 99 |
Outcome results
Primary
Percentage of Participants With an sUA Level That is < 5.0 mg/dL
Percentage of participants in Study 307 With sUA \< 5.0 mg/dL from the Core Studies 304 and Extension Study 307 - Observed Cases
Time frame: Up to approximately 2.5 years (at Extension Month 12)
Population: Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed Extension Month 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesinurad 400 mg + Febuxostat 80 mg | Percentage of Participants With an sUA Level That is < 5.0 mg/dL | 82.5 Percentage of participants |
| Lesinurad 200 mg + Febuxostat 80 mg | Percentage of Participants With an sUA Level That is < 5.0 mg/dL | 77.8 Percentage of participants |
Secondary
Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus
Percentage of participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus During the Core and Extension Studies at Extension Month 12 (Observed Cases)
Time frame: Up to approximatley 2.5 years (at Extension Month 12)
Population: ITT Population Number of Participants Analyzed for this Outcome Measure reflects the number of participants who completed through Month 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Lesinurad 400 mg + Febuxostat 80 mg | Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus | 61.0 Percentage of participants |
| Lesinurad 200 mg + Febuxostat 80 mg | Percentage of Participants (With at Least One Target Tophus at Baseline) Who Experience Complete Resolution of at Least One Target Tophus | 54.3 Percentage of participants |