A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

NCT07089888 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: FYU-981-CRYS-3022024-520207-84-00
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 78

Brief Summary

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 tophaceous gout.

Conditions

Tophaceous Gout

Keywords

Tophaceous Gout; Dotinurad; Allopurinol; Hyperuricemia

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24

  Week 24

Secondary Outcomes (16)

• Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76

  Week 76

• Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76

  Week 76

• Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24

  Week 24

• Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76

  Week 36 through Week 76

• Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 and No Gout Flares Requiring Treatment from Week 36 Through Week 76

  Week 24 and Week 36 through Week 76

Study Arms (2)

Allopurinol

ACTIVE COMPARATOR

Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76.

Drug: Allopurinol

Dotinurad

EXPERIMENTAL

Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4), dotinurad 2 mg QD for the next 8 weeks (Weeks 5-12), and dotinurad 4 mg QD thereafter up through Week 76.

Drug: Dotinurad

Interventions

Allopurinol DRUG

Over-encapsulated tablets containing active drug substance administered orally (PO).

Allopurinol

Dotinurad DRUG

Over-encapsulated tablets containing active drug substance administered PO.

Dotinurad

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year.
• Has ≥1 measurable tophus on the hands/wrists and/or feet/ankles between Screening and Day 1. A measurable tophus is defined as ≥5 mm and ≤30 mm in the longest diameter.
• sUA level ≥5.0 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.

You may not qualify if:

• 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 colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs).
• 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 antibodies (HCV) during Screening.

Sponsors & Collaborators

• Crystalys Therapeutics: lead

Study Sites (78)

Alabama Clinical Therapeutics

Birmingham, Alabama, 35235, United States

WITHDRAWN

G & L Research

Foley, Alabama, 36535, United States

RECRUITING

Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert

Gilbert, Arizona, 85297, United States

RECRUITING

Arizona Arthritis & Rheumatology Associates (AARA) - Glendale

Glendale, Arizona, 85306, United States

RECRUITING

Arizona Arthritis & Rheumatology Associates (AARA) - Mesa

Mesa, Arizona, 85210, United States

RECRUITING

Del Sol Research Management - Tucson East

Tucson, Arizona, 85715, United States

RECRUITING

Medvin Clinical Research - Covina

Covina, California, 91722, United States

RECRUITING

West Coast Research

Dublin, California, 94568, United States

RECRUITING

Infinity Clinical Research

Norco, California, 92860, United States

RECRUITING

Amicis Research Center - Balboa

Northridge, California, 91324, United States

RECRUITING

Dream Team Clinical Research

Pomona, California, 91767, United States

WITHDRAWN

Acclaim Clinical Research, Inc.

San Diego, California, 92120, United States

RECRUITING

East Bay Rheumatology Medical Group

San Leandro, California, 94578, United States

RECRUITING

BTC Network - Encompass Clinical Research

Spring Valley, California, 91978, United States

RECRUITING

Cohen Medical Centers

Thousand Oaks, California, 91360-3967, United States

RECRUITING

Medvin Clinical Research - Tujunga

Tujunga, California, 91042, United States

RECRUITING

Denver Arthritis Clinic - Lowry

Denver, Colorado, 80230, United States

RECRUITING

Bradenton Research Center

Bradenton, Florida, 34205, United States

RECRUITING

Herco Medical and Research Center, Inc

Coral Gables, Florida, 33134, United States

RECRUITING

New Generation of Medical Research

Hialeah, Florida, 32016, United States

RECRUITING

Best Quality Research

Hialeah, Florida, 33016, United States

RECRUITING

Health Awareness Inc

Jupiter, Florida, 33458, United States

RECRUITING

Clinical Research of Center Florida

Lakeland, Florida, 33805, United States

RECRUITING

D&H Pompano Research Center

Margate, Florida, 33063, United States

RECRUITING

Anchor Medical Research, LLC

Miami, Florida, 33176, United States

RECRUITING

Panax Clinical Research

Miami Lakes, Florida, 33014, United States

RECRUITING

Omega Research DeBary

Orlando, Florida, 32808, United States

RECRUITING

Clinical Research Trials of Florida

Tampa, Florida, 33607, United States

RECRUITING

Conquest Research - Winter Park

Winter Park, Florida, 32789, United States

RECRUITING

DelRicht Research - Atlanta

Atlanta, Georgia, 30329, United States

WITHDRAWN

Chicago Clinical Research Institute, Inc. (CCRII)

Chicago, Illinois, 60607, United States

RECRUITING

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)

Chicago, Illinois, 60640, United States

RECRUITING

MediSphere Medical Research Center, LLC - East

Evansville, Indiana, 47714, United States

RECRUITING

Delricht Research - Better Life Direct Primary Care

Indianapolis, Indiana, 46202, United States

WITHDRAWN

Delricht Research - Concierge And Direct Primary Care

Overland Park, Kansas, 66223, United States

RECRUITING

DelRicht Research - Louisville (Derby City DPC)

Louisville, Kentucky, 40205, United States

RECRUITING

Tandem Clinical Research - Metairie Clinic

Metairie, Louisiana, 70006, United States

RECRUITING

DelRicht Research - LCMC Health Urgent Care - Lakeview

New Orleans, Louisiana, 70124, United States

RECRUITING

DelRicht Research - Prairieville

Prairieville, Louisiana, 70769, United States

RECRUITING

MD Medical Research - Oxon Hill

Oxon Hill, Maryland, 20745, United States

RECRUITING

DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)

Rockville, Maryland, 20852, United States

WITHDRAWN

MedVadis Research

Waltham, Massachusetts, 02451, United States

RECRUITING

A. Alfred Taubman Health Care Center

Ann Arbor, Michigan, 48109, United States

RECRUITING

DM Clinical Research - Detroit

Southfield, Michigan, 48076, United States

WITHDRAWN

Revival Research Institute - Sterling Heights

Sterling Heights, Michigan, 48313, United States

RECRUITING

Oakland Medical Center

Troy, Michigan, 48085, United States

RECRUITING

Delricht Research - Command Family Medicine

Springfield, Missouri, 65807, United States

WITHDRAWN

DelRicht Research - Town and Country

Town and Country, Missouri, 63017, United States

RECRUITING

Las Vegas Clinical Trials

North Las Vegas, Nevada, 89030, United States

RECRUITING

Sahni Rheumatology & Therapy

West Long Branch, New Jersey, 07764, United States

RECRUITING

Ellipsis Research Group

Brooklyn, New York, 11215, United States

RECRUITING

NYU Langone Health

New York, New York, 10016, United States

RECRUITING

DelRicht Research - Charlotte (Direct Primary Care - DPC)

Charlotte, North Carolina, 28205, United States

RECRUITING

Shelby Clinical Research, LLC - North Carolina

Shelby, North Carolina, 28150, United States

RECRUITING

Hometown Urgent Care and Research - Dayton

Dayton, Ohio, 45424, United States

RECRUITING

Delricht Research - Concierge Medicine Of Cincinnati

Mason, Ohio, 45040, United States

WITHDRAWN

DelRicht Research - Tulsa

Tulsa, Oklahoma, 74133, United States

WITHDRAWN

Suburban Research Associates - West Chester Office

West Chester, Pennsylvania, 19380, United States

WITHDRAWN

Coastal Carolina Research Center - Main

North Charleston, South Carolina, 29405, United States

RECRUITING

Health Concepts

Rapid City, South Dakota, 57702, United States

RECRUITING

DelRicht Research - Hendersonville

Hendersonville, Tennessee, 37075, United States

WITHDRAWN

Arthritis & Osteoporosis Center of Coastal Bend

Corpus Christi, Texas, 78415, United States

RECRUITING

Zenos Clinical Research

Dallas, Texas, 75230, United States

RECRUITING

Lone Star Arthritis & Rheumatology Associates - Denton

Denton, Texas, 76205, United States

RECRUITING

Epic Medical Research - DeSoto

DeSoto, Texas, 75115, United States

RECRUITING

Prolato Clinical Research Center

Houston, Texas, 77027, United States

RECRUITING

Pioneeer Research Solutions

Houston, Texas, 77099, United States

RECRUITING

R & H Clinical Research - South Fry Road

Katy, Texas, 77450, United States

RECRUITING

Premise Clinical Research Center

Lancaster, Texas, 75146, United States

RECRUITING

Alliance Clinical Lewisville (Epic Clinical Research)

Lewisville, Texas, 75057, United States

RECRUITING

Southwest Rheumatology Research

Mesquite, Texas, 75150, United States

RECRUITING

Discovery Clinical Trials

San Antonio, Texas, 78229, United States

RECRUITING

ERG - Endeavor Clinical Trials

San Antonio, Texas, 78240, United States

RECRUITING

Siena Research Network

Sugar Land, Texas, 77479, United States

RECRUITING

DM Clinical Research - Tomball - Multiple Specialties

Tomball, Texas, 77375, United States

RECRUITING

Rio Clinical Trials - Corporate Office

Ogden, Utah, 84404, United States

RECRUITING

Charlottesville Medical Research

Charlottesville, Virginia, 22911, United States

RECRUITING

Gershon Pain Specialists

Virginia Beach, Virginia, 23454, United States

RECRUITING

Related Links

• Related Info
• Related Info

MeSH Terms

Conditions

Hyperuricemia

Interventions

Allopurinol; dotinurad

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Clinical Trial Lead

CONTACT

(858) 356-4740; ClinicalTrials@crystalystx.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: July 28, 2025
• Study Start: August 4, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

US (78)