A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants

Part of paid clinical trials in Granada Hills, California.

Sponsor
Crystalys Therapeutics
Study ID
NCT07535034
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Dotinurad — DRUG
    Over-encapsulated tablets containing active drug substance administered orally.
  • Placebo — OTHER
    Capsules containing microcrystalline cellulose administered orally.

Study Details

The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.

Key Dates

Start date
May 8, 2026
Status verified
Jun 2026
Primary completion
Jul 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Dotinurad
    The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take dotinurad (Treatment Period 1) followed by a 12-week period where participants will continue to take dotinurad (Treatment Period 2).
  • Experimental: Placebo + Placebo to Dotinuard
    The Treatment Period will consist of 2 consecutive parts: a 24-week period where participants will take placebo (Treatment Period 1) followed by a 12-week treatment period where participants will take dotinurad (Treatment Period 2).

Primary Outcome Measure

Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24 [ Time Frame: Week 24 ]

Central Contacts

Locations (17)

FacilityCityStateZIPSite coordinators
Amicis Research CenterGranada HillsCalifornia91344
Pascal Dabel, MD
Cohen Medical CenterThousand OaksCalifornia91360
Shariar Cohen-Gadol, MD
Omega Research GroupDeBaryFlorida32713
Kwabena Ayesu, MD
Clinical Research of Central FloridaLakelandFlorida33805
Michael Gimness, MD
Anchor Medical ResearchMiamiFlorida33176
Juvenal Martinez, MD
Panax Clinical ResearchMiamiFlorida33014
Robert Perry, MD
MD Medical ResearchOxon HillMaryland20745
Stephen Ong, MD
Clinical Research Institute of MichiganSaint Clair ShoresMichigan48081
Amar Majjhoo, MD
Revival Research InstituteSterling HeightsMichigan48313
Syed Husain, MD
Las Vegas Clinical TrialsLas VegasNevada89030
Alton Walters, MD
Ellipsis Research GroupBrooklynNew York11215
Jorge Serje, MD
Drug Trials AmericaHartsdaleNew York10530
Michael Gerdis, MD
Shelby Clinical ResearchShelbyNorth Carolina28150
Christian Martin, MD
Zenos Clinical ResearchDallasTexas75230
Bachar Elsaadi, MD
Epic Medical ResearchDeSotoTexas75115
Haresh Boghara, MD
Pioneer Research SolutionsHoustonTexas77479
Francisco Velazquez, MD
DM Clinical ResearchTomballTexas77375
Shaikh Ali, MD

Find similar trials in Granada Hills, CA

By research site
Amicis Research Center· Granada Hills, CACohen Medical Center· Thousand Oaks, CAOmega Research Group· DeBary, FLClinical Research of Central Florida· Lakeland, FLAnchor Medical Research· Miami, FLPanax Clinical Research· Miami, FL

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