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RecruitingPhase 3

A Study of Dotinurad Versus Allopurinol in Participants With Gout

Crystalys Therapeutics · NCT07089875

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–75 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
500
US sites recruiting
82
Study start
August 1, 2025
Record last updated
September 28, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.

Being studied: Allopurinol; Dotinurad

Conditions: Gout

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • 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.
  • Had at least 2 gout flares in the 12 months prior to Screening (reported by the participant or documented in the participant's medical records).
  • Participant must be on a stable background allopurinol dose of ≥300 mg/day (200 mg/day for those with moderate renal impairment as documented in the participant's medical history) up to 600 mg/day for at least 3 months prior to Screening and remain on their dosing regimen until Day 1.
  • sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 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 -35 Visit) and Screening Visit 2 (Day -7 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 study drug.

Exclusion Criteria

  • 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.
  • Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.
  • 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, Hepatitis B Surface Antigen, or Hepatitis C antibodies 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 study compliance or may confound interpretation of study results.

Recruiting US locations

  • University of Alabama at Birmingham

    Birmingham, AL 35233

    Site contact: Kenneth Saag, MD

  • G&L Research

    Foley, AL 36535

    Site contact: Nidal Morrar, MD

  • Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

    Gilbert, AZ 85297

    Site contact: Daniel Kreutz, MD

  • Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

    Glendale, AZ 85306

    Site contact: Nehad Soloman, MD

  • Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

    Mesa, AZ 85110

    Site contact: Swati Bharadwaj, MD

  • Del Sol Research Management - Tucson East

    Tucson, AZ 85715

    Site contact: Vicki Kalen, MD

  • Medvin Clinical Research - Covina

    Covina, CA 91722

    Site contact: Samy Metyas, MD

  • West Coast Research

    Dublin, CA 94568

    Site contact: Tim Davis

  • Southland Arthritis and Osteoporosis Medical Center, Inc

    Menifee, CA 92586

    Site contact: Amal Mehta, MD

  • Infinity Clinical Research

    Norco, CA 92860

    Site contact: Peter Mattar, MD

  • Amicis Research Center - Balboa

    Northridge, CA 91324

    Site contact: Pascal Dabel, MD

  • Velocity Clinical Research - San Bernardino

    San Bernardino, CA 92408

    Site contact: Judith Albay, MD

  • Acclaim Clinical Research, Inc.

    San Diego, CA 92120

    Site contact: Julie Vu, MD

  • East Bay Rheumatology Medical Group

    San Leandro, CA 94578

    Site contact: Suneet Grewal, MD

  • BTC Network - Encompass Clinical Research

    Spring Valley, CA 91978

    Site contact: Hanid Audish, MD

  • Cohen Medical Centers

    Thousand Oaks, CA 91360-3967

    Site contact: Shariar Cohen-Gadol, MD

  • Medvin Clinical Research - Tujunga

    Tujunga, CA 91042

    Site contact: Dan La, MD

  • Denver Arthritis Clinic - Lowry

    Denver, CO 80230

    Site contact: Christopher Antolini, MD

  • Bradenton Research Center

    Bradenton, FL 34205

    Site contact: Eric Folkens, MD

  • Herco Medical and Research Center, Inc

    Coral Gables, FL 33134

    Site contact: Eddy Capote, MD

  • New Generation of Medical Research

    Hialeah, FL 32016

    Site contact: Karelia Ruiz, MD

  • Best Quality Research

    Hialeah, FL 33016

    Site contact: Gustavo Ledo-Sanchez, MD

  • Health Awareness Inc

    Jupiter, FL 33458

    Site contact: Ronald Surowitz, MD

  • Clinical Research of Center Florida

    Lakeland, FL 33805

    Site contact: Michael Gimness, MD

  • Anchor Medical Research, LLC

    Miami, FL 33176

    Site contact: Juvenal Martinez, MD

  • Panax Clinical Research

    Miami Lakes, FL 33014

    Site contact: Robert G. Perry, MD

  • Omega Research DeBary

    Orlando, FL 32808

    Site contact: Kwabena Ayesu, MD

  • D&H Pompano Research Center

    Pompano Beach, FL 33064

    Site contact: Mazyar Rouhani, MD

  • Clinical Research Trials of Florida

    Tampa, FL 33607

    Site contact: Viviana Fonseca

  • Conquest Research - Winter Park

    Winter Park, FL 32789

    Site contact: Anand Patel, MD

  • Pediatrics & Adult Medicine/SKYCRNG

    Decatur, GA 30034

    Site contact: Michele Sewell, MD

  • SKYCRNG - Rophe Adult and Pediatric Medicine

    Decatur, GA 30034

    Site contact: Dwight Blake, MD

  • Chicago Clinical Research Institute, Inc. (CCRII)

    Chicago, IL 60607

    Site contact: Manognya Sama

  • Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

    Chicago, IL 60640

    Site contact: Manish Jain, MD

  • Healthcare Research Network - Tinley Park

    Flossmoor, IL 60402

    Site contact: Ronald Stumbris, MD

  • Gateway Clinical Trials

    O'Fallon, IL 62269

    Site contact: Christopher Anderson, MD

  • Investigators Research Group

    Brownsburg, IN 46112

    Site contact: Kenneth Maynard, MD

  • MediSphere Medical Research Center, LLC

    Evansville, IN 47714

    Site contact: Hubert Reyes, MD

  • Delricht Research - Concierge And Direct Primary Care

    Overland Park, KS 66223

    Site contact: Jonathan T. Jacobs, MD

  • DelRicht Research - Louisville (Derby City DPC)

    Louisville, KY 40205

    Site contact: Michael Lovelace, MD

  • DelRicht Research - LCMC Health Urgent Care - Lakeview

    New Orleans, LA 70124

    Site contact: Emily Krambeck

  • DelRicht Research - Prairieville

    Prairieville, LA 70769

    Site contact: Brittany Bolton

  • MD Medical Research - Oxon Hill

    Oxon Hill, MD 20745

    Site contact: Stephen Ong, MD

  • MedVadis Research

    Waltham, MA 02451

    Site contact: David DiBenedetto, MD

  • Michigan Medicine - University of Michigan

    Ann Arbor, MI 48109-5000

    Site contact: Puja Khanna, MD

  • Clinical Research Institute of Michigan - St. Clair Shores

    Saint Clair Shores, MI 48081

    Site contact: Amar Majjhoo, MD

  • Revive Research Institute - Sterling Heights

    Sterling Heights, MI 48313

    Site contact: Syed Ali Muttaqi Husain, MD

  • Oakland Medical Center

    Troy, MI 48085

    Site contact: Jay Sandberg, MD

  • DelRicht Research - Town and Country

    Town and Country, MO 63017

    Site contact: Amy E. Roberts, MD

  • Boeson Research - Great Falls

    Great Falls, MT 59405

    Site contact: Richard Horng-Chy Lai, MD

  • Las Vegas Clinical Trials

    North Las Vegas, NV 89030

    Site contact: Alton Walters, MD

  • Curalta Clinical Trials

    Oradell, NJ 07649

    Site contact: Vincent Giacalone, MD

  • Premier Health Research

    Sparta, NJ 07871

    Site contact: Haroon Sarwar, MD

  • Sahni Rheumatology & Therapy

    West Long Branch, NJ 07764

    Site contact: Kiren Sahni, MD

  • Ellipsis Research Group

    Brooklyn, NY 11215

    Site contact: Jorge Serje, MD

  • NYU Langone Health

    New York, NY 10016

    Site contact: Michael Pillinger, MD

  • DelRicht Research

    Charlotte, NC 28210

    Site contact: Olabisi Badmus, MD

  • Carteret Medical Group LLC

    Morehead City, NC 28557

    Site contact: Mary Lawrence, MD

  • Shelby Clinical Research, LLC - North Carolina

    Shelby, NC 28150

    Site contact: Christian Martin, MD

  • Hometown Urgent Care and Research - Dayton

    Dayton, OH 45424

    Site contact: Steve Choi, MD

+ 22 more on the official record.

Study contacts (from the official record)

  • Clinical Trial Lead · 1-858-379-2316 · ClinicalTrials@crystalystx.com
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A Study of Dotinurad Versus Allopurinol in Participants With Gout (NCT07089875) | Bored Studies