A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
Key facts
- Where
- Amarillo, Atlanta, Birmingham, Brooklyn, Charlotte, Chicago, Dallas, Dayton, DeBary, Denver, DeSoto, Flagami, Granada Hills, Hartsdale, Hialeah, Houston, Jupiter, Katy, Lakeland, Las Vegas, Lexington, Margate, Mesquite, Miami, Norfolk, Oxon Hill, Phoenix, Rockville, Saint Clair Shores, San Antonio, Shelby, Sparta, Sterling Heights, Thousand Oaks, Tomball, Troy, Tucson, Tustin, Waco, and Wichita Falls, United StatesSee the 41 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07535034, who can take part
Where in United States
- Amarillo Premier ResearchAmarillo, United StatesContact: Susan Neese, MDTaking people
- Southwest Atlanta Internal MedicineAtlanta, United StatesContact: Tamara Brown, MDTaking people
- The Kirklin Clinic of UAB HospitalBirmingham, United StatesContact: Kenneth Saag, MDTaking people
- Ellipsis Research GroupBrooklyn, United StatesContact: Jorge Serje, MDTaking people
- DJL Clinical ResearchCharlotte, United StatesContact: Emily Jane Herron Box, MDTaking people
- Great Lakes Clinical TrialsChicago, United StatesContact: Manish Jain, MDTaking people
- Zenos Clinical ResearchDallas, United StatesContact: Bachar Elsaadi, MDTaking people
- Hometown Urgent Care and ResearchDayton, United StatesContact: Carol Bland, MDTaking people
- Omega Research GroupDeBary, United StatesContact: Kwabena Ayesu, MDTaking people
- Denver Arthritis Clinic - LowryDenver, United StatesContact: Christopher Antolini, MDTaking people
- Epic Medical ResearchDeSoto, United StatesContact: Haresh Boghara, MDTaking people
- Herco Medical and Research Center, IncFlagami, United StatesContact: Eddy Capote, MDTaking people
- Amicis Research CenterGranada Hills, United StatesContact: Pascal Dabel, MDTaking people
- Drug Trials AmericaHartsdale, United StatesContact: Michael Gerdis, MDTaking people
- New Generation of Medical ResearchHialeah, United StatesContact: Karelia Ruiz, MDTaking people
- Pioneer Research SolutionsHouston, United StatesContact: Francisco Velazquez, MDTaking people
- Health Awareness, IncJupiter, United StatesContact: Ronald Surowitz, MDTaking people
- R&H Clinical Research - Westborough DriveKaty, United StatesContact: Maryam Khawari, MDTaking people
- Clinical Research of Central FloridaLakeland, United StatesContact: Michael Gimness, MDTaking people
- Las Vegas Clinical TrialsLas Vegas, United StatesContact: Alton Walters, MDTaking people
- Research Group of Lexington, LLCLexington, United StatesContact: Justin Arambasick, MDTaking people
- D&H Pompano Research Center, LLCMargate, United StatesContact: Mazyar Rouhani, MDTaking people
- Southwest Rheumatology ResearchMesquite, United StatesContact: Atul Singhal, MDTaking people
- Anchor Medical ResearchMiami, United StatesContact: Juvenal Martinez, MDTaking people
- Panax Clinical ResearchMiami, United StatesContact: Robert Perry, MDTaking people
- Velocity Clinical ResearchNorfolk, United StatesContact: Charles Harper, MDTaking people
- MD Medical ResearchOxon Hill, United StatesContact: Stephen Ong, MDTaking people
- Arizona Arthritis & Rheumatology Research, PLLCPhoenix, United StatesContact: Nita Kumar, MDTaking people
- AARA Clinical Research-Arthritis and Rheumatism AssociatesRockville, United StatesContact: Evan Siegel, MDTaking people
- Clinical Research Institute of MichiganSaint Clair Shores, United StatesContact: Amar Majjhoo, MDTaking people
- Discovery Clinical Trials LLCSan Antonio, United StatesContact: Abha Gyani, MDTaking people
- Shelby Clinical ResearchShelby, United StatesContact: Christian Martin, MDTaking people
- Premier Health ResearchSparta, United StatesContact: Haroon Sarwar, MDTaking people
- Revival Research InstituteSterling Heights, United StatesContact: Syed Husain, MDTaking people
- Cohen Medical CenterThousand Oaks, United StatesContact: Shariar Cohen-Gadol, MDTaking people
- DM Clinical ResearchTomball, United StatesContact: Shaikh Ali, MDTaking people
- Oakland Medical Research CenterTroy, United StatesContact: Jay Sandberg, MDTaking people
- AARA Clinical Research-SE TucsonTucson, United StatesContact: Romy Cabacungan, MDTaking people
- Solace Clinical ResearchTustin, United StatesContact: Roger Kornu, MDTaking people
- Velocity Clinical Research (Impact Research Institute)Waco, United StatesContact: Hing-Sheung Fung, MDTaking people
- Digestive Health Research of North TexasWichita Falls, United StatesContact: Vanya Wagler, MDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Crystalys Therapeutics
- Trial code
- NCT07535034
- Record updated
- 28 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 2, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad in Adult Participants With Gout Who Are Intolerant to Xanthine Oxidase Inhibitors or Failed Uricase Treatment
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.
Inclusion: Between 18 and 75 years of age (inclusive) at the time of signing informed consent; Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:; History (either by medical record or participant interview) of intolerance or a contraindication to either allopurinol or febuxostat; Failed uricase treatment (eg, an sUA level >6.0 mg/dL at least 2 weeks after last infusion; intolerant or contraindicated to uricase treatment); sUA level >6.0 and <10.5 mg/dL at both Screening Visit 1 (Day -28 Visit) and Screening Visit 2 (Day -7 Visit); Female participants of childbearing potential must have a negative serum pregnancy test at Screening Visit 1 (Day -28 Visit), a negative urine pregnancy test on Day 1, and must not be breastfeeding; Fertile male participants and female participants of childbearing potential must be willing to completely abstain from heterosexual sex or agree to use acceptable contraception from the time of signing informed consent through 30 days after the last dose of trial drug.
Exclusion: History of or presence of kidney stones within 1 year prior to Screening; History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma; Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse; Known history of or positive results for human immunodeficiency virus (HIV), Hepatitis B surface antigen (HBsAg), or Hepatitis C virus (HCV) during Screening; Current or historical evidence of any clinically significant disease or condition that, in the opinion of the Investigator, may compromise participant safety or trial compliance or may confound interpretation of trial results.