Actively Recruiting
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adults With Tophaceous Gout
Led by Crystalys Therapeutics · Updated on 2026-05-20
250
Participants Needed
86
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of dotinurad compared to allopurinol in lowering serum uric acid levels in adults with tophaceous gout. This Phase 3 study focuses on patients who have had gout for at least one year and have measurable tophi. The primary goal is to see how well dotinurad lowers uric acid by Week 24 compared with allopurinol. Participants will stop taking their current allopurinol and begin study-supplied allopurinol once daily through Week 76 or start dotinurad with a dose escalation from 1 mg daily in the first 4 weeks, to 2 mg daily for the next 8 weeks, and then 4 mg daily through Week 76. The study is randomized and double-blind, comparing these two treatments over this period. During the study, participants will have their serum uric acid levels measured at various points, including Week 24 and up to Week 80. Researchers will also monitor tophi response, gout flare rates, and safety outcomes such as adverse events. The total participation could last up to 80 weeks, with ongoing assessments to track treatment effects and tolerability.
CONDITIONS
Brief Title
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
- Diagnosis of gout based on 2015 ACR-EULAR criteria for at least 1 year.
- Has one or more measurable tophi on hands, wrists, feet, or ankles between Screening and Day 1, defined as 5 mm to 30 mm in longest diameter.
- Serum uric acid level of 5.0 mg/dL or higher at Screening Visits.
- Female participants of childbearing potential must have negative pregnancy tests at screening and Day 1, and must not be breastfeeding.
- Fertile male participants and females of childbearing potential must agree to abstain from heterosexual sex or use contraception from consent through 30 days after last study dose.
You will not qualify if you...
- History or presence of kidney stones within 1 year prior to Screening.
- History or presence of malignancy in the last 5 years, except treated basal or squamous cell carcinoma.
- Hypersensitivity or intolerance to dotinurad, colchicine, or NSAIDs.
- Known or suspected drug abuse, positive drug test at Screening, or recent alcohol abuse.
- History of or positive test for HIV, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 76 weeks
Participants receive study medication, either allopurinol or dotinurad, to manage tophaceous gout.
Trial Site Locations
Total: 86 locations
1
The Kirklin Clinic of University of Alabama Birmingham Hospital
Birmingham, Alabama, United States, 35233
Actively Recruiting
2
Alabama Clinical Therapeutics
Birmingham, Alabama, United States, 35235
Withdrawn
3
G & L Research
Foley, Alabama, United States, 36535
Actively Recruiting
4
Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona, United States, 85297
Actively Recruiting
5
Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona, United States, 85306
Actively Recruiting
6
Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona, United States, 85210
Actively Recruiting
7
Del Sol Research Management - Tucson East
Tucson, Arizona, United States, 85715
Actively Recruiting
8
Medvin Clinical Research - Covina
Covina, California, United States, 91722
Actively Recruiting
9
West Coast Research
Dublin, California, United States, 94568
Actively Recruiting
10
Infinity Clinical Research
Norco, California, United States, 92860
Actively Recruiting
11
Amicis Research Center - Balboa
Northridge, California, United States, 91324
Actively Recruiting
12
Cure Clinical Research, LLC
Orange, California, United States, 92866
Actively Recruiting
13
Dream Team Clinical Research
Pomona, California, United States, 91767
Withdrawn
14
Velocity Clinical Research - San Bernardino
San Bernardino, California, United States, 92408
Actively Recruiting
15
Acclaim Clinical Research, Inc.
San Diego, California, United States, 92120
Actively Recruiting
16
East Bay Rheumatology Medical Group
San Leandro, California, United States, 94578
Actively Recruiting
17
BTC Network - Encompass Clinical Research
Spring Valley, California, United States, 91978
Actively Recruiting
18
Cohen Medical Centers
Thousand Oaks, California, United States, 91360-3967
Actively Recruiting
19
Medvin Clinical Research - Tujunga
Tujunga, California, United States, 91042
Actively Recruiting
20
Denver Arthritis Clinic - Lowry
Denver, Colorado, United States, 80230
Actively Recruiting
21
Bradenton Research Center
Bradenton, Florida, United States, 34205
Actively Recruiting
22
Herco Medical and Research Center, Inc
Coral Gables, Florida, United States, 33134
Actively Recruiting
23
New Generation of Medical Research
Hialeah, Florida, United States, 32016
Actively Recruiting
24
Best Quality Research
Hialeah, Florida, United States, 33016
Actively Recruiting
25
Health Awareness Inc
Jupiter, Florida, United States, 33458
Actively Recruiting
26
Clinical Research of Center Florida
Lakeland, Florida, United States, 33805
Actively Recruiting
27
D&H Pompano Research Center
Margate, Florida, United States, 33063
Actively Recruiting
28
Well Pharma Medical Research
Miami, Florida, United States, 33173
Actively Recruiting
29
Anchor Medical Research, LLC
Miami, Florida, United States, 33176
Actively Recruiting
30
Panax Clinical Research
Miami Lakes, Florida, United States, 33014
Actively Recruiting
31
Omega Research DeBary
Orlando, Florida, United States, 32808
Actively Recruiting
32
Clinical Research Trials of Florida
Tampa, Florida, United States, 33607
Actively Recruiting
33
Conquest Research - Winter Park
Winter Park, Florida, United States, 32789
Actively Recruiting
34
DelRicht Research - Atlanta
Atlanta, Georgia, United States, 30329
Withdrawn
35
Chicago Clinical Research Institute, Inc. (CCRII)
Chicago, Illinois, United States, 60607
Actively Recruiting
36
Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago, Illinois, United States, 60640
Actively Recruiting
37
MediSphere Medical Research Center, LLC - East
Evansville, Indiana, United States, 47714
Actively Recruiting
38
Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana, United States, 46202
Withdrawn
39
Delricht Research - Concierge And Direct Primary Care
Overland Park, Kansas, United States, 66223
Actively Recruiting
40
DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky, United States, 40205
Actively Recruiting
41
Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana, United States, 70006
Actively Recruiting
42
DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana, United States, 70124
Actively Recruiting
43
DelRicht Research - Prairieville
Prairieville, Louisiana, United States, 70769
Actively Recruiting
44
MD Medical Research - Oxon Hill
Oxon Hill, Maryland, United States, 20745
Actively Recruiting
45
DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville, Maryland, United States, 20852
Withdrawn
46
MedVadis Research
Waltham, Massachusetts, United States, 02451
Actively Recruiting
47
A. Alfred Taubman Health Care Center
Ann Arbor, Michigan, United States, 48109
Actively Recruiting
48
Clinical Research Institute of Michigan - St. Clair Shores
Saint Clair Shores, Michigan, United States, 48081
Actively Recruiting
49
DM Clinical Research - Detroit
Southfield, Michigan, United States, 48076
Withdrawn
50
Revival Research Institute - Sterling Heights
Sterling Heights, Michigan, United States, 48313
Actively Recruiting
51
Oakland Medical Center
Troy, Michigan, United States, 48085
Actively Recruiting
52
Delricht Research - Command Family Medicine
Springfield, Missouri, United States, 65807
Withdrawn
53
DelRicht Research - Town and Country
Town and Country, Missouri, United States, 63017
Actively Recruiting
54
Las Vegas Clinical Trials
North Las Vegas, Nevada, United States, 89030
Actively Recruiting
55
Sahni Rheumatology & Therapy
West Long Branch, New Jersey, United States, 07764
Actively Recruiting
56
Ellipsis Research Group
Brooklyn, New York, United States, 11215
Actively Recruiting
57
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
58
DelRicht Research
Charlotte, North Carolina, United States, 28210
Actively Recruiting
59
Triad Clinical Trials
Greensboro, North Carolina, United States, 27410
Actively Recruiting
60
Shelby Clinical Research, LLC - North Carolina
Shelby, North Carolina, United States, 28150
Actively Recruiting
61
Hometown Urgent Care and Research - Dayton
Dayton, Ohio, United States, 45424
Actively Recruiting
62
Delricht Research - Concierge Medicine Of Cincinnati
Mason, Ohio, United States, 45040
Withdrawn
63
DelRicht Research - Tulsa
Tulsa, Oklahoma, United States, 74133
Withdrawn
64
Suburban Research Associates - West Chester Office
West Chester, Pennsylvania, United States, 19380
Withdrawn
65
Coastal Carolina Research Center - Main
North Charleston, South Carolina, United States, 29405
Actively Recruiting
66
Health Concepts
Rapid City, South Dakota, United States, 57702
Actively Recruiting
67
DelRicht Research - Hendersonville
Hendersonville, Tennessee, United States, 37075
Withdrawn
68
Arthritis & Osteoporosis Center of Coastal Bend
Corpus Christi, Texas, United States, 78415
Actively Recruiting
69
Zenos Clinical Research
Dallas, Texas, United States, 75230
Actively Recruiting
70
Lone Star Arthritis & Rheumatology Associates - Denton
Denton, Texas, United States, 76205
Actively Recruiting
71
Epic Medical Research - DeSoto
DeSoto, Texas, United States, 75115
Actively Recruiting
72
Prolato Clinical Research Center
Houston, Texas, United States, 77027
Actively Recruiting
73
Pioneeer Research Solutions
Houston, Texas, United States, 77099
Actively Recruiting
74
Epic Medical Research - Hurst
Hurst, Texas, United States, 76054
Actively Recruiting
75
R & H Clinical Research - South Fry Road
Katy, Texas, United States, 77450
Actively Recruiting
76
Premise Clinical Research Center
Lancaster, Texas, United States, 75146
Actively Recruiting
77
Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas, United States, 75057
Actively Recruiting
78
Southwest Rheumatology Research
Mesquite, Texas, United States, 75150
Actively Recruiting
79
Discovery Clinical Trials
San Antonio, Texas, United States, 78229
Actively Recruiting
80
ERG - Endeavor Clinical Trials
San Antonio, Texas, United States, 78240
Actively Recruiting
81
Epic Medical Research - San Marcos
San Marcos, Texas, United States, 78666
Actively Recruiting
82
Siena Research Network
Sugar Land, Texas, United States, 77479
Actively Recruiting
83
DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas, United States, 77375
Actively Recruiting
84
Rio Clinical Trials - Corporate Office
Ogden, Utah, United States, 84404
Actively Recruiting
85
Charlottesville Medical Research
Charlottesville, Virginia, United States, 22911
Actively Recruiting
86
Gershon Pain Specialists
Virginia Beach, Virginia, United States, 23454
Actively Recruiting
Research Team
C
Clinical Trial Lead
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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