Clinical Trials List
2023-07-31 - 2026-04-30
Phase II/III
Recruiting3
Study ended1
ICD-10M10.00
Idiopathic gout, unspecified site
ICD-10M10.011
Idiopathic gout, right shoulder
ICD-10M10.012
Idiopathic gout, left shoulder
ICD-10M10.019
Idiopathic gout, unspecified shoulder
ICD-10M10.021
Idiopathic gout, right elbow
ICD-10M10.022
Idiopathic gout, left elbow
ICD-10M10.029
Idiopathic gout, unspecified elbow
ICD-10M10.031
Idiopathic gout, right wrist
ICD-10M10.032
Idiopathic gout, left wrist
ICD-10M10.039
Idiopathic gout, unspecified wrist
ICD-10M10.041
Idiopathic gout, right hand
ICD-10M10.042
Idiopathic gout, left hand
ICD-10M10.049
Idiopathic gout, unspecified hand
ICD-10M10.051
Idiopathic gout, right hip
ICD-10M10.052
Idiopathic gout, left hip
ICD-10M10.059
Idiopathic gout, unspecified hip
ICD-10M10.061
Idiopathic gout, right knee
ICD-10M10.062
Idiopathic gout, left knee
ICD-10M10.069
Idiopathic gout, unspecified knee
ICD-10M10.071
Idiopathic gout, right ankle and foot
ICD-10M10.072
Idiopathic gout, left ankle and foot
ICD-10M10.079
Idiopathic gout, unspecified ankle and foot
ICD-10M10.08
Idiopathic gout, vertebrae
ICD-10M10.09
Idiopathic gout, multiple sites
ICD-10M10.10
Lead-induced gout, unspecified site
ICD-10M10.111
Lead-induced gout, right shoulder
ICD-10M10.112
Lead-induced gout, left shoulder
ICD-10M10.119
Lead-induced gout, unspecified shoulder
ICD-10M10.121
Lead-induced gout, right elbow
ICD-10M10.122
Lead-induced gout, left elbow
ICD-10M10.129
Lead-induced gout, unspecified elbow
ICD-10M10.131
Lead-induced gout, right wrist
ICD-10M10.132
Lead-induced gout, left wrist
ICD-10M10.139
Lead-induced gout, unspecified wrist
ICD-10M10.141
Lead-induced gout, right hand
ICD-10M10.142
Lead-induced gout, left hand
ICD-10M10.149
Lead-induced gout, unspecified hand
ICD-10M10.151
Lead-induced gout, right hip
ICD-10M10.152
Lead-induced gout, left hip
ICD-10M10.159
Lead-induced gout, unspecified hip
ICD-10M10.161
Lead-induced gout, right knee
ICD-10M10.162
Lead-induced gout, left knee
ICD-10M10.169
Lead-induced gout, unspecified knee
ICD-10M10.171
Lead-induced gout, right ankle and foot
ICD-10M10.172
Lead-induced gout, left ankle and foot
ICD-10M10.179
Lead-induced gout, unspecified ankle and foot
ICD-10M10.18
Lead-induced gout, vertebrae
ICD-10M10.19
Lead-induced gout, multiple sites
ICD-10M10.20
Drug-induced gout, unspecified site
ICD-10M10.211
Drug-induced gout, right shoulder
ICD-10M10.212
Drug-induced gout, left shoulder
ICD-10M10.219
Drug-induced gout, unspecified shoulder
ICD-10M10.221
Drug-induced gout, right elbow
ICD-10M10.222
Drug-induced gout, left elbow
ICD-10M10.229
Drug-induced gout, unspecified elbow
ICD-10M10.231
Drug-induced gout, right wrist
ICD-10M10.232
Drug-induced gout, left wrist
ICD-10M10.239
Drug-induced gout, unspecified wrist
ICD-10M10.241
Drug-induced gout, right hand
ICD-10M10.242
Drug-induced gout, left hand
ICD-10M10.249
Drug-induced gout, unspecified hand
ICD-10M10.251
Drug-induced gout, right hip
ICD-10M10.252
Drug-induced gout, left hip
ICD-10M10.259
Drug-induced gout, unspecified hip
ICD-10M10.261
Drug-induced gout, right knee
ICD-10M10.262
Drug-induced gout, left knee
ICD-10M10.269
Drug-induced gout, unspecified knee
ICD-10M10.271
Drug-induced gout, right ankle and foot
ICD-10M10.272
Drug-induced gout, left ankle and foot
ICD-10M10.279
Drug-induced gout, unspecified ankle and foot
ICD-10M10.28
Drug-induced gout, vertebrae
ICD-10M10.29
Drug-induced gout, multiple sites
ICD-10M1A.00X0
Idiopathic chronic gout, unspecified site, without tophus (tophi)
ICD-10M1A.00X1
Idiopathic chronic gout, unspecified site, with tophus (tophi)
ICD-10M1A.0110
Idiopathic chronic gout, right shoulder, without tophus (tophi)
ICD-10M1A.0111
Idiopathic chronic gout, right shoulder, with tophus (tophi)
ICD-10M1A.0120
Idiopathic chronic gout, left shoulder, without tophus (tophi)
ICD-10M1A.0121
Idiopathic chronic gout, left shoulder, with tophus (tophi)
ICD-10M1A.0190
Idiopathic chronic gout, unspecified shoulder, without tophus (tophi)
ICD-10M1A.0191
Idiopathic chronic gout, unspecified shoulder, with tophus (tophi)
ICD-10M1A.0210
Idiopathic chronic gout, right elbow, without tophus (tophi)
ICD-10M1A.0211
Idiopathic chronic gout, right elbow, with tophus (tophi)
ICD-10M1A.0220
Idiopathic chronic gout, left elbow, without tophus (tophi)
ICD-10M1A.0221
Idiopathic chronic gout, left elbow, with tophus (tophi)
ICD-10M1A.0290
Idiopathic chronic gout, unspecified elbow, without tophus (tophi)
ICD-10M1A.0291
Idiopathic chronic gout, unspecified elbow, with tophus (tophi)
ICD-10M1A.0310
Idiopathic chronic gout, right wrist, without tophus (tophi)
ICD-10M1A.0311
Idiopathic chronic gout, right wrist, with tophus (tophi)
ICD-10M1A.0320
Idiopathic chronic gout, left wrist, without tophus (tophi)
ICD-10M1A.0321
Idiopathic chronic gout, left wrist, with tophus (tophi)
ICD-10M1A.0390
Idiopathic chronic gout, unspecified wrist, without tophus (tophi)
ICD-10M1A.0391
Idiopathic chronic gout, unspecified wrist, with tophus (tophi)
ICD-10M1A.0410
Idiopathic chronic gout, right hand, without tophus (tophi)
ICD-10M1A.0411
Idiopathic chronic gout, right hand, with tophus (tophi)
ICD-10M1A.0420
Idiopathic chronic gout, left hand, without tophus (tophi)
ICD-10M1A.0421
Idiopathic chronic gout, left hand, with tophus (tophi)
ICD-10M1A.0490
Idiopathic chronic gout, unspecified hand, without tophus (tophi)
ICD-10M1A.0491
Idiopathic chronic gout, unspecified hand, with tophus (tophi)
ICD-10M1A.0510
Idiopathic chronic gout, right hip, without tophus (tophi)
ICD-10M1A.0511
Idiopathic chronic gout, right hip, with tophus (tophi)
ICD-10M1A.0520
Idiopathic chronic gout, left hip, without tophus (tophi)
ICD-10M1A.0521
Idiopathic chronic gout, left hip, with tophus (tophi)
ICD-10M1A.0590
Idiopathic chronic gout, unspecified hip, without tophus (tophi)
ICD-10M1A.0591
Idiopathic chronic gout, unspecified hip, with tophus (tophi)
ICD-10M1A.0610
Idiopathic chronic gout, right knee, without tophus (tophi)
ICD-10M1A.0611
Idiopathic chronic gout, right knee, with tophus (tophi)
ICD-10M1A.0620
Idiopathic chronic gout, left knee, without tophus (tophi)
ICD-10M1A.0621
Idiopathic chronic gout, left knee, with tophus (tophi)
ICD-10M1A.0690
Idiopathic chronic gout, unspecified knee, without tophus (tophi)
ICD-10M1A.0691
Idiopathic chronic gout, unspecified knee, with tophus (tophi)
ICD-10M1A.0710
Idiopathic chronic gout, right ankle and foot, without tophus (tophi)
ICD-10M1A.0711
Idiopathic chronic gout, right ankle and foot, with tophus (tophi)
ICD-10M1A.0720
Idiopathic chronic gout, left ankle and foot, without tophus (tophi)
ICD-10M1A.0721
Idiopathic chronic gout, left ankle and foot, with tophus (tophi)
ICD-10M1A.0790
Idiopathic chronic gout, unspecified ankle and foot, without tophus (tophi)
ICD-10M1A.0791
Idiopathic chronic gout, unspecified ankle and foot, with tophus (tophi)
ICD-10M1A.08X0
Idiopathic chronic gout, vertebrae, without tophus (tophi)
ICD-10M1A.08X1
Idiopathic chronic gout, vertebrae, with tophus (tophi)
ICD-10M1A.09X0
Idiopathic chronic gout, multiple sites, without tophus (tophi)
ICD-10M1A.09X1
Idiopathic chronic gout, multiple sites, with tophus (tophi)
ICD-10M1A.20X0
Drug-induced chronic gout, unspecified site, without tophus (tophi)
ICD-10M1A.2110
Drug-induced chronic gout, right shoulder, without tophus (tophi)
ICD-10M1A.2111
Drug-induced chronic gout, right shoulder, with tophus (tophi)
ICD-10M1A.2120
Drug-induced chronic gout, left shoulder, without tophus (tophi)
ICD-10M1A.2121
Drug-induced chronic gout, left shoulder, with tophus (tophi)
ICD-10M1A.2190
Drug-induced chronic gout, unspecified shoulder, without tophus (tophi)
ICD-10M1A.2191
Drug-induced chronic gout, unspecified shoulder, with tophus (tophi)
ICD-10M1A.2210
Drug-induced chronic gout, right elbow, without tophus (tophi)
ICD-10M1A.2211
Drug-induced chronic gout, right elbow, with tophus (tophi)
ICD-10M1A.2220
Drug-induced chronic gout, left elbow, without tophus (tophi)
ICD-10M1A.2221
Drug-induced chronic gout, left elbow, with tophus (tophi)
ICD-10M1A.2290
Drug-induced chronic gout, unspecified elbow, without tophus (tophi)
ICD-10M1A.2291
Drug-induced chronic gout, unspecified elbow, with tophus (tophi)
ICD-10M1A.2310
Drug-induced chronic gout, right wrist, without tophus (tophi)
ICD-10M1A.2311
Drug-induced chronic gout, right wrist, with tophus (tophi)
ICD-10M1A.2320
Drug-induced chronic gout, left wrist, without tophus (tophi)
ICD-10M1A.2321
Drug-induced chronic gout, left wrist, with tophus (tophi)
ICD-10M1A.2390
Drug-induced chronic gout, unspecified wrist, without tophus (tophi)
ICD-10M1A.2391
Drug-induced chronic gout, unspecified wrist, with tophus (tophi)
ICD-10M1A.2410
Drug-induced chronic gout, right hand, without tophus (tophi)
ICD-10M1A.2411
Drug-induced chronic gout, right hand, with tophus (tophi)
ICD-10M1A.2420
Drug-induced chronic gout, left hand, without tophus (tophi)
ICD-10M1A.2421
Drug-induced chronic gout, left hand, with tophus (tophi)
ICD-10M1A.2490
Drug-induced chronic gout, unspecified hand, without tophus (tophi)
ICD-10M1A.2491
Drug-induced chronic gout, unspecified hand, with tophus (tophi)
ICD-10M1A.2510
Drug-induced chronic gout, right hip, without tophus (tophi)
ICD-10M1A.2511
Drug-induced chronic gout, right hip, with tophus (tophi)
ICD-10M1A.2520
Drug-induced chronic gout, left hip, without tophus (tophi)
ICD-10M1A.2521
Drug-induced chronic gout, left hip, with tophus (tophi)
ICD-10M1A.2590
Drug-induced chronic gout, unspecified hip, without tophus (tophi)
ICD-10M1A.2591
Drug-induced chronic gout, unspecified hip, with tophus (tophi)
ICD-10M1A.2610
Drug-induced chronic gout, right knee, without tophus (tophi)
ICD-10M1A.2611
Drug-induced chronic gout, right knee, with tophus (tophi)
ICD-10M1A.2620
Drug-induced chronic gout, left knee, without tophus (tophi)
ICD-10M1A.2621
Drug-induced chronic gout, left knee, with tophus (tophi)
ICD-10M1A.2690
Drug-induced chronic gout, unspecified knee, without tophus (tophi)
ICD-10M1A.2691
Drug-induced chronic gout, unspecified knee, with tophus (tophi)
ICD-10M1A.2710
Drug-induced chronic gout, right ankle and foot, without tophus (tophi)
ICD-10M1A.2711
Drug-induced chronic gout, right ankle and foot, with tophus (tophi)
ICD-10M1A.2720
Drug-induced chronic gout, left ankle and foot, without tophus (tophi)
ICD-10M1A.2721
Drug-induced chronic gout, left ankle and foot, with tophus (tophi)
ICD-10M1A.2790
Drug-induced chronic gout, unspecified ankle and foot, without tophus (tophi)
ICD-10M1A.2791
Drug-induced chronic gout, unspecified ankle and foot, with tophus (tophi)
ICD-10M1A.28X0
Drug-induced chronic gout, vertebrae, without tophus (tophi)
ICD-10M1A.28X1
Drug-induced chronic gout, vertebrae, with tophus (tophi)
ICD-10M1A.29X0
Drug-induced chronic gout, multiple sites, without tophus (tophi)
ICD-10M1A.29X1
Drug-induced chronic gout, multiple sites, with tophus (tophi)
ICD-10M1A.30X0
Chronic gout due to renal impairment, unspecified site, without tophus (tophi)
ICD-10M1A.3110
Chronic gout due to renal impairment, right shoulder, without tophus (tophi)
ICD-10M1A.3111
Chronic gout due to renal impairment, right shoulder, with tophus (tophi)
ICD-10M1A.3120
Chronic gout due to renal impairment, left shoulder, without tophus (tophi)
ICD-10M1A.3121
Chronic gout due to renal impairment, left shoulder, with tophus (tophi)
ICD-10M1A.3190
Chronic gout due to renal impairment, unspecified shoulder, without tophus (tophi)
ICD-10M1A.3191
Chronic gout due to renal impairment, unspecified shoulder, with tophus (tophi)
ICD-10M1A.3210
Chronic gout due to renal impairment, right elbow, without tophus (tophi)
ICD-10M1A.3211
Chronic gout due to renal impairment, right elbow, with tophus (tophi)
ICD-10M1A.3220
Chronic gout due to renal impairment, left elbow, without tophus (tophi)
ICD-10M1A.3221
Chronic gout due to renal impairment, left elbow, with tophus (tophi)
ICD-10M1A.3290
Chronic gout due to renal impairment, unspecified elbow, without tophus (tophi)
ICD-10M1A.3291
Chronic gout due to renal impairment, unspecified elbow, with tophus (tophi)
ICD-10M1A.3310
Chronic gout due to renal impairment, right wrist, without tophus (tophi)
ICD-10M1A.3311
Chronic gout due to renal impairment, right wrist, with tophus (tophi)
ICD-10M1A.3320
Chronic gout due to renal impairment, left wrist, without tophus (tophi)
ICD-10M1A.3321
Chronic gout due to renal impairment, left wrist, with tophus (tophi)
ICD-10M1A.3390
Chronic gout due to renal impairment, unspecified wrist, without tophus (tophi)
ICD-10M1A.3391
Chronic gout due to renal impairment, unspecified wrist, with tophus (tophi)
ICD-10M1A.3410
Chronic gout due to renal impairment, right hand, without tophus (tophi)
ICD-10M1A.3411
Chronic gout due to renal impairment, right hand, with tophus (tophi)
ICD-10M1A.3420
Chronic gout due to renal impairment, left hand, without tophus (tophi)
ICD-10M1A.3421
Chronic gout due to renal impairment, left hand, with tophus (tophi)
ICD-10M1A.3490
Chronic gout due to renal impairment, unspecified hand, without tophus (tophi)
ICD-10M1A.3491
Chronic gout due to renal impairment, unspecified hand, with tophus (tophi)
ICD-10M1A.3510
Chronic gout due to renal impairment, right hip, without tophus (tophi)
ICD-10M1A.3511
Chronic gout due to renal impairment, right hip, with tophus (tophi)
ICD-10M1A.3520
Chronic gout due to renal impairment, left hip, without tophus (tophi)
ICD-10M1A.3521
Chronic gout due to renal impairment, left hip, with tophus (tophi)
ICD-10M1A.3590
Chronic gout due to renal impairment, unspecified hip, without tophus (tophi)
ICD-10M1A.3591
Chronic gout due to renal impairment, unspecified hip, with tophus (tophi)
ICD-10M1A.3610
Chronic gout due to renal impairment, right knee, without tophus (tophi)
ICD-10M1A.3611
Chronic gout due to renal impairment, right knee, with tophus (tophi)
ICD-10M1A.3620
Chronic gout due to renal impairment, left knee, without tophus (tophi)
ICD-10M1A.3621
Chronic gout due to renal impairment, left knee, with tophus (tophi)
ICD-10M1A.3690
Chronic gout due to renal impairment, unspecified knee, without tophus (tophi)
ICD-10M1A.3691
Chronic gout due to renal impairment, unspecified knee, with tophus (tophi)
ICD-10M1A.3710
Chronic gout due to renal impairment, right ankle and foot, without tophus (tophi)
ICD-10M1A.3711
Chronic gout due to renal impairment, right ankle and foot, with tophus (tophi)
ICD-10M1A.3720
Chronic gout due to renal impairment, left ankle and foot, without tophus (tophi)
ICD-10M1A.3721
Chronic gout due to renal impairment, left ankle and foot, with tophus (tophi)
ICD-10M1A.3790
Chronic gout due to renal impairment, unspecified ankle and foot, without tophus (tophi)
ICD-10M1A.3791
Chronic gout due to renal impairment, unspecified ankle and foot, with tophus (tophi)
ICD-10M1A.38X0
Chronic gout due to renal impairment, vertebrae, without tophus (tophi)
ICD-10M1A.38X1
Chronic gout due to renal impairment, vertebrae, with tophus (tophi)
ICD-10M1A.39X0
Chronic gout due to renal impairment, multiple sites, without tophus (tophi)
ICD-10M1A.39X1
Chronic gout due to renal impairment, multiple sites, with tophus (tophi)
ICD-10M1A.40X0
Other secondary chronic gout, unspecified site, without tophus (tophi)
ICD-10M1A.4110
Other secondary chronic gout, right shoulder, without tophus (tophi)
ICD-10M1A.4111
Other secondary chronic gout, right shoulder, with tophus (tophi)
ICD-10M1A.4120
Other secondary chronic gout, left shoulder, without tophus (tophi)
ICD-10M1A.4121
Other secondary chronic gout, left shoulder, with tophus (tophi)
ICD-10M1A.4190
Other secondary chronic gout, unspecified shoulder, without tophus (tophi)
ICD-10M1A.4191
Other secondary chronic gout, unspecified shoulder, with tophus (tophi)
ICD-10M1A.4210
Other secondary chronic gout, right elbow, without tophus (tophi)
ICD-10M1A.4211
Other secondary chronic gout, right elbow, with tophus (tophi)
ICD-10M1A.4220
Other secondary chronic gout, left elbow, without tophus (tophi)
ICD-10M1A.4221
Other secondary chronic gout, left elbow, with tophus (tophi)
ICD-10M1A.4290
Other secondary chronic gout, unspecified elbow, without tophus (tophi)
ICD-10M1A.4291
Other secondary chronic gout, unspecified elbow, with tophus (tophi)
ICD-10M1A.4310
Other secondary chronic gout, right wrist, without tophus (tophi)
ICD-10M1A.4311
Other secondary chronic gout, right wrist, with tophus (tophi)
ICD-10M1A.4320
Other secondary chronic gout, left wrist, without tophus (tophi)
ICD-10M1A.4321
Other secondary chronic gout, left wrist, with tophus (tophi)
ICD-10M1A.4390
Other secondary chronic gout, unspecified wrist, without tophus (tophi)
ICD-10M1A.4391
Other secondary chronic gout, unspecified wrist, with tophus (tophi)
ICD-10M1A.4410
Other secondary chronic gout, right hand, without tophus (tophi)
ICD-10M1A.4411
Other secondary chronic gout, right hand, with tophus (tophi)
ICD-10M1A.4420
Other secondary chronic gout, left hand, without tophus (tophi)
ICD-10M1A.4421
Other secondary chronic gout, left hand, with tophus (tophi)
ICD-10M1A.4490
Other secondary chronic gout, unspecified hand, without tophus (tophi)
ICD-10M1A.4491
Other secondary chronic gout, unspecified hand, with tophus (tophi)
ICD-10M1A.4510
Other secondary chronic gout, right hip, without tophus (tophi)
ICD-10M1A.4511
Other secondary chronic gout, right hip, with tophus (tophi)
ICD-10M1A.4520
Other secondary chronic gout, left hip, without tophus (tophi)
ICD-10M1A.4521
Other secondary chronic gout, left hip, with tophus (tophi)
ICD-10M1A.4590
Other secondary chronic gout, unspecified hip, without tophus (tophi)
ICD-10M1A.4591
Other secondary chronic gout, unspecified hip, with tophus (tophi)
ICD-10M1A.4610
Other secondary chronic gout, right knee, without tophus (tophi)
ICD-10M1A.4611
Other secondary chronic gout, right knee, with tophus (tophi)
ICD-10M1A.4620
Other secondary chronic gout, left knee, without tophus (tophi)
ICD-10M1A.4621
Other secondary chronic gout, left knee, with tophus (tophi)
ICD-10M1A.4690
Other secondary chronic gout, unspecified knee, without tophus (tophi)
ICD-10M1A.4691
Other secondary chronic gout, unspecified knee, with tophus (tophi)
ICD-10M1A.4710
Other secondary chronic gout, right ankle and foot, without tophus (tophi)
ICD-10M1A.4711
Other secondary chronic gout, right ankle and foot, with tophus (tophi)
ICD-10M1A.4720
Other secondary chronic gout, left ankle and foot, without tophus (tophi)
ICD-10M1A.4721
Other secondary chronic gout, left ankle and foot, with tophus (tophi)
ICD-10M1A.4790
Other secondary chronic gout, unspecified ankle and foot, without tophus (tophi)
ICD-10M1A.4791
Other secondary chronic gout, unspecified ankle and foot, with tophus (tophi)
ICD-10M1A.48X0
Other secondary chronic gout, vertebrae, without tophus (tophi)
ICD-10M1A.48X1
Other secondary chronic gout, vertebrae, with tophus (tophi)
ICD-10M1A.49X0
Other secondary chronic gout, multiple sites, without tophus (tophi)
ICD-10M1A.49X1
Other secondary chronic gout, multiple sites, with tophus (tophi)
ICD-10M1A.9XX0
Chronic gout, unspecified, without tophus (tophi)
ICD-10M1A.9XX1
Chronic gout, unspecified, with tophus (tophi)
ICD-9274.0
Gouty arthropathy
A Multicenter, Randomized, Double-blind, Controlled, Phase 2b/3 Study to Assess the Efficacy and Safety of ABP-671 in Participants With Gout
-
Trial Applicant
Syneos Health
-
Sponsor
Taiwan Syneos Health Company Limited
-
Trial scale
Multi-Regional Multi-Center
-
Update
2026/03/01
Investigators and Locations
Co-Principal Investigator
- 陳英州 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Recruiting
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 徐翊庭 Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Yao-Fan Fang Division of Rheumatology
- Chen-I Hsieh Division of Rheumatology
- 蕭朝陽 Division of Rheumatology
- 陳彥輔 Division of Rheumatology
- 張哲慈 Division of Rheumatology
The Actual Total Number of Participants Enrolled
0 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
Inclution Criteria
• Male and female participants aged ≥19 and <70 years of age at the time of informed consent.
• A body mass index (BMI) of ≥18 kg/m2 to ≤40 kg/m2.
• Diagnosis of gout per American College of Rheumatology/European Alliance of Associations for Rheumatology 2015 Gout Classification Criteria and must meet the criteria as follows:
o At Screening, participants with gout on ULT (including allopurinol) must be willing to discontinue ULT.
o At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L).
• At the confirmatory sUA visit, all participants must have an sUA ≥7.0 mg/dL (≥0.420 mmol/L).
• Women of childbearing potential (WOCBP) must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or willing to use acceptable and highly effective double contraception from Screening until at least 30 days after the last dose of the study drug. Double contraception is defined as a condom AND one other form of the following:
o Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones);
o A vaginal ring or an intrauterine device OR
o Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is the sole partner). The absence of records will not exclude screening the participant; if medical records cannot be obtained, serum pregnancy testing will be conducted to confirm the participant is not pregnant.
Note: Women not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through follicle stimulating hormone (FSH) concentration testing.
-Men must be surgically sterile (>30 days since vasectomy), abstinent, or if engaged in sexual relations with a female partner of childbearing potential, the participant must use an acceptable form of contraception from Screening until at least 30 days after the last dose of the study drug. Acceptable methods of contraception include the use of condoms in addition to the use of an effective contraceptive for the female partner that includes approved oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device. Participants who practice abstinence (abstinence from penile-vaginal intercourse) are eligible when this is in line with their preferred and usual lifestyle. In addition, men must not donate sperm for at least 30 days after the last dose of the study drug.
Exclusion Criteria
• Male and female participants aged ≥19 and <70 years of age at the time of informed consent.
• A body mass index (BMI) of ≥18 kg/m2 to ≤40 kg/m2.
• Diagnosis of gout per American College of Rheumatology/European Alliance of Associations for Rheumatology 2015 Gout Classification Criteria and must meet the criteria as follows:
o At Screening, participants with gout on ULT (including allopurinol) must be willing to discontinue ULT.
o At Screening, participants with gout who are not currently treated with any UA lowering therapy must have an sUA ≥7.5 mg/dL (≥0.450 mmol/L).
• At the confirmatory sUA visit, all participants must have an sUA ≥7.0 mg/dL (≥0.420 mmol/L).
• Women of childbearing potential (WOCBP) must be surgically sterile (eg, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or willing to use acceptable and highly effective double contraception from Screening until at least 30 days after the last dose of the study drug. Double contraception is defined as a condom AND one other form of the following:
o Established hormonal contraception (with approved oral contraceptive pills, long-acting implantable hormones, injectable hormones);
o A vaginal ring or an intrauterine device OR
o Documented evidence of surgical sterilization at least 6 months prior to Screening (eg, tubal occlusion, hysterectomy, bilateral salpingectomy, or bilateral oophorectomy for women or vasectomy for men [with appropriate post-vasectomy documentation of the absence of sperm in semen] provided the male partner is the sole partner). The absence of records will not exclude screening the participant; if medical records cannot be obtained, serum pregnancy testing will be conducted to confirm the participant is not pregnant.
Note: Women not of childbearing potential must be postmenopausal for ≥12 months. Postmenopausal status will be confirmed through follicle stimulating hormone (FSH) concentration testing.
-Men must be surgically sterile (>30 days since vasectomy), abstinent, or if engaged in sexual relations with a female partner of childbearing potential, the participant must use an acceptable form of contraception from Screening until at least 30 days after the last dose of the study drug. Acceptable methods of contraception include the use of condoms in addition to the use of an effective contraceptive for the female partner that includes approved oral contraceptive pills, long-acting implantable hormones, injectable hormones, a vaginal ring, or an intrauterine device. Participants who practice abstinence (abstinence from penile-vaginal intercourse) are eligible when this is in line with their preferred and usual lifestyle. In addition, men must not donate sperm for at least 30 days after the last dose of the study drug.
The Estimated Number of Participants
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Taiwan
60 participants
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Global
580 participants
