A Study of Dotinurad Versus Allopurinol in Participants With Gout

September 1, 2026 updated by: Crystalys Therapeutics

A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Hyperuricemia Associated With Gout

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 60-529
        • Recruiting
        • Centrum Medyczne Solumed
        • Contact:
          • Kamilla Klama, MD
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-501
        • Recruiting
        • FutureMeds - Krakow
        • Contact:
          • Weronika Kleczynska-Szpakiewicz, MD
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-673
        • Recruiting
        • FutureMeds - Wroclaw
        • Contact:
          • Ewa Krecipro-Nizińska, MD
    • Masovian Voivodeship
      • Plońsk, Masovian Voivodeship, Poland, 09-100
        • Recruiting
        • Innova Clinic
        • Contact:
          • Tomasz Wysocki, MD
      • Sochaczew, Masovian Voivodeship, Poland, 96-500
        • Recruiting
        • Prolato Clinical Research Center
        • Contact:
          • Monika Wronisz, MD
      • Warsaw, Masovian Voivodeship, Poland, 03-291
        • Recruiting
        • FutureMeds - Targowek
        • Contact:
          • Agnieszka Jurek-Urbanowska, MD
      • Warsaw, Masovian Voivodeship, Poland, 00-872
        • Recruiting
        • Medicover Integrated Clinical Services- MICS Centrum Medyczne Warszawa Chlodna
        • Contact:
          • Magdalena Szuflińska-Sidorowicz, MD
    • Podlaskie Voivodeship
      • Bialystok, Podlaskie Voivodeship, Poland, 15-077
        • Recruiting
        • Inter Clinic
        • Contact:
          • Piotr Klimiuk, MD
      • Bialystok, Podlaskie Voivodeship, Poland, 15-879
        • Recruiting
        • ClinicMed Daniluk Nowak Spółka Komandytowa
        • Contact:
          • Stefan Daniluk, MD
    • Pomeranian Voivodeship
      • Gdynia, Pomeranian Voivodeship, Poland, 81-537
        • Recruiting
        • FutureMeds Gdynia
        • Contact:
          • Barbara Grabowicz-Waśko, MD
      • Wejherowo, Pomeranian Voivodeship, Poland, 84-200
        • Recruiting
        • Med-Progress Ośrodek Nowoczesnego Leczenia
        • Contact:
          • Maciej Osińsk, MD
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-122
        • Recruiting
        • Pro Familia - Katowice
        • Contact:
          • Danuta Wronska, MD
      • Katowice, Silesian Voivodeship, Poland, 40-282
        • Recruiting
        • Silmedic Sp. z o.o.
        • Contact:
          • Karina Sitek-Ziolkowska, MD
  • Spain
      • Barcelona, Spain, 08041
        • Recruiting
        • Hospital de La Santa Creu i Sant Pau
        • Contact:
          • Cesar Diaz-Torne, MD
    • La Coruña
      • A Coruña, La Coruña, Spain, 15006
        • Recruiting
        • Complejo Hospitalario Universitario A Coruña
        • Contact:
          • Francisco Javier Blanco Garcia, MD
      • Santiago de Compostela, La Coruña, Spain, 15706
        • Recruiting
        • Clinica Gaias Santiago
        • Contact:
          • Juan José Amarelo Ramos, MD
    • Madrid
      • Alcobendas, Madrid, Spain, 28100
        • Recruiting
        • Accellacare - Alcobendas
        • Contact:
          • Gualberto Diaz Saez, MD
      • Madrid, Madrid, Spain, 28032
        • Recruiting
        • Hospital Universitario Infanta Leonor
        • Contact:
          • Enrique Calvo Aranda, MD
    • Sevilla
      • Seville, Sevilla, Spain, 41010
        • Recruiting
        • Hospital Quironsalud Infanta Luisa
        • Contact:
          • Lola Fernández de la Fuente Bursón, MD
      • Seville, Sevilla, Spain, 46010
        • Recruiting
        • Clínica NTDE - Nuevas Tecnologías en Diabetes y Endocrinología
        • Contact:
          • Alberto Aliaga Verdugo, MD
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35233
        • Recruiting
        • University of Alabama at Birmingham
        • Contact:
          • Kenneth Saag, MD
      • Birmingham, Alabama, United States, 35235
        • Withdrawn
        • Alabama Clinical Therapeutics
      • Foley, Alabama, United States, 36535
        • Recruiting
        • G&L Research
        • Contact:
          • Nidal Morrar, MD
    • Arizona
      • Gilbert, Arizona, United States, 85297
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
        • Contact:
          • Daniel Kreutz, MD
      • Glendale, Arizona, United States, 85306
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
        • Contact:
          • Nehad Soloman, MD
      • Mesa, Arizona, United States, 85110
        • Recruiting
        • Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
        • Contact:
          • Swati Bharadwaj, MD
      • Tucson, Arizona, United States, 85715
        • Recruiting
        • Del Sol Research Management - Tucson East
        • Contact:
          • Vicki Kalen, MD
    • California
      • Covina, California, United States, 91722
        • Recruiting
        • Medvin Clinical Research - Covina
        • Contact:
          • Samy Metyas, MD
      • Dublin, California, United States, 94568
        • Recruiting
        • West Coast Research
        • Contact:
        • Principal Investigator:
          • Alfred Tan, MD
      • Menifee, California, United States, 92586
        • Recruiting
        • Southland Arthritis and Osteoporosis Medical Center, Inc
        • Contact:
          • Amal Mehta, MD
      • Norco, California, United States, 92860
        • Recruiting
        • Infinity Clinical Research
        • Contact:
          • Peter Mattar, MD
      • Northridge, California, United States, 91324
        • Recruiting
        • Amicis Research Center - Balboa
        • Contact:
          • Pascal Dabel, MD
      • Pomona, California, United States, 91767
        • Withdrawn
        • Dream Team Clinical Research
      • San Bernardino, California, United States, 92408
        • Recruiting
        • Velocity Clinical Research - San Bernardino
        • Contact:
          • Judith Albay, MD
      • San Diego, California, United States, 92120
        • Recruiting
        • Acclaim Clinical Research, Inc.
        • Contact:
          • Julie Vu, MD
      • San Leandro, California, United States, 94578
        • Recruiting
        • East Bay Rheumatology Medical Group
        • Contact:
          • Suneet Grewal, MD
      • Spring Valley, California, United States, 91978
        • Recruiting
        • BTC Network - Encompass Clinical Research
        • Contact:
          • Hanid Audish, MD
      • Thousand Oaks, California, United States, 91360-3967
        • Recruiting
        • Cohen Medical Centers
        • Contact:
          • Shariar Cohen-Gadol, MD
      • Tujunga, California, United States, 91042
        • Recruiting
        • Medvin Clinical Research - Tujunga
        • Contact:
          • Dan La, MD
    • Colorado
      • Denver, Colorado, United States, 80230
        • Recruiting
        • Denver Arthritis Clinic - Lowry
        • Contact:
          • Christopher Antolini, MD
    • Florida
      • Bradenton, Florida, United States, 34205
        • Recruiting
        • Bradenton Research Center
        • Contact:
          • Eric Folkens, MD
      • Coral Gables, Florida, United States, 33134
        • Recruiting
        • Herco Medical and Research Center, Inc
        • Contact:
          • Eddy Capote, MD
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Best Quality Research
        • Contact:
          • Gustavo Ledo-Sanchez, MD
      • Hialeah, Florida, United States, 32016
        • Recruiting
        • New Generation Of Medical Research
        • Contact:
          • Karelia Ruiz, MD
      • Jupiter, Florida, United States, 33458
        • Recruiting
        • Health Awareness INC
        • Contact:
          • Ronald Surowitz, MD
      • Lakeland, Florida, United States, 33805
        • Recruiting
        • Clinical Research of Center Florida
        • Contact:
          • Michael Gimness, MD
      • Miami, Florida, United States, 33176
        • Recruiting
        • Anchor Medical Research, LLC
        • Contact:
          • Juvenal Martinez, MD
      • Miami Lakes, Florida, United States, 33014
        • Recruiting
        • Panax Clinical Research
        • Contact:
          • Robert G. Perry, MD
      • Orlando, Florida, United States, 32808
        • Recruiting
        • Omega Research DeBary
        • Contact:
          • Kwabena Ayesu, MD
      • Pompano Beach, Florida, United States, 33064
        • Recruiting
        • D&H Pompano Research Center
        • Contact:
          • Mazyar Rouhani, MD
      • Tampa, Florida, United States, 33607
        • Recruiting
        • Clinical Research Trials of Florida
        • Contact:
        • Principal Investigator:
          • Sady Alpizar, MD
      • Winter Park, Florida, United States, 32789
        • Recruiting
        • Conquest Research - Winter Park
        • Contact:
          • Anand Patel, MD
    • Georgia
      • Atlanta, Georgia, United States, 30329
        • Withdrawn
        • DelRicht Research - Atlanta
      • Decatur, Georgia, United States, 30034
        • Recruiting
        • SKYCRNG - Rophe Adult and Pediatric Medicine
        • Contact:
          • Dwight Blake, MD
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Recruiting
        • Chicago Clinical Research Institute, Inc. (CCRII)
        • Principal Investigator:
          • Dennis Levinson, MD
        • Contact:
          • Manognya Sama
      • Chicago, Illinois, United States, 60640
        • Recruiting
        • Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
        • Contact:
          • Manish Jain, MD
      • Flossmoor, Illinois, United States, 60402
        • Recruiting
        • Healthcare Research Network - Tinley Park
        • Contact:
          • Ronald Stumbris, MD
      • O'Fallon, Illinois, United States, 62269
        • Recruiting
        • Gateway Clinical Trials
        • Contact:
          • Christopher Anderson, MD
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Recruiting
        • Investigators Research Group
        • Contact:
          • Kenneth Maynard, MD
      • Evansville, Indiana, United States, 47714
        • Recruiting
        • MediSphere Medical Research Center, LLC
        • Contact:
          • Hubert Reyes, MD
      • Indianapolis, Indiana, United States, 46202
        • Withdrawn
        • Delricht Research - Better Life Direct Primary Care
    • Kansas
      • Overland Park, Kansas, United States, 66223
        • Recruiting
        • Delricht Research - Concierge And Direct Primary Care
        • Contact:
          • Jonathan T. Jacobs, MD
    • Kentucky
      • Louisville, Kentucky, United States, 40205
        • Recruiting
        • DelRicht Research - Louisville (Derby City DPC)
        • Contact:
          • Michael Lovelace, MD
    • Louisiana
      • Metairie, Louisiana, United States, 70006
        • Active, not recruiting
        • Tandem Clinical Research - Metairie Clinic
      • New Orleans, Louisiana, United States, 70124
        • Recruiting
        • DelRicht Research - LCMC Health Urgent Care - Lakeview
        • Principal Investigator:
          • Patrick Dennis, MD
        • Contact:
      • Prairieville, Louisiana, United States, 70769
        • Recruiting
        • DelRicht Research - Prairieville
        • Principal Investigator:
          • Taylor Sanders, MD
        • Contact:
    • Maryland
      • Oxon Hill, Maryland, United States, 20745
        • Recruiting
        • MD Medical Research - Oxon Hill
        • Contact:
          • Stephen Ong, MD
      • Rockville, Maryland, United States, 20852
        • Withdrawn
        • DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
    • Massachusetts
      • Waltham, Massachusetts, United States, 02451
        • Recruiting
        • MedVadis Research
        • Contact:
          • David DiBenedetto, MD
    • Michigan
      • Ann Arbor, Michigan, United States, 48109-5000
        • Recruiting
        • Michigan Medicine - University of Michigan
        • Contact:
          • Puja Khanna, MD
      • Saint Clair Shores, Michigan, United States, 48081
        • Recruiting
        • Clinical Research Institute of Michigan - St. Clair Shores
        • Contact:
          • Amar Majjhoo, MD
      • Southfield, Michigan, United States, 48076
        • Withdrawn
        • DM Clinical Research - Detroit
      • Sterling Heights, Michigan, United States, 48313
        • Recruiting
        • Revive Research Institute - Sterling Heights
        • Contact:
          • Syed Ali Muttaqi Husain, MD
      • Troy, Michigan, United States, 48085
        • Recruiting
        • Oakland Medical Center
        • Contact:
          • Jay Sandberg, MD
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Withdrawn
        • Healthcare Research Network
      • Springfield, Missouri, United States, 65807
        • Withdrawn
        • Delricht Research - Command Family Medicine
      • Town and Country, Missouri, United States, 63017
        • Recruiting
        • DelRicht Research - Town and Country
        • Contact:
          • Amy E. Roberts, MD
    • Montana
      • Great Falls, Montana, United States, 59405
        • Recruiting
        • Boeson Research - Great Falls
        • Contact:
          • Richard Horng-Chy Lai, MD
    • Nevada
      • North Las Vegas, Nevada, United States, 89030
        • Recruiting
        • Las Vegas Clinical Trials
        • Contact:
          • Alton Walters, MD
    • New Jersey
      • Oradell, New Jersey, United States, 07649
        • Recruiting
        • Curalta Clinical Trials
        • Contact:
          • Vincent Giacalone, MD
      • Sparta, New Jersey, United States, 07871
        • Recruiting
        • Premier Health Research
        • Contact:
          • Haroon Sarwar, MD
    • New York
      • Brooklyn, New York, United States, 11215
        • Recruiting
        • Ellipsis Research Group
        • Contact:
          • Jorge Serje, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • Michael Pillinger, MD
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Recruiting
        • DelRicht Research
        • Contact:
          • Olabisi Badmus, MD
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Carteret Medical Group LLC
        • Contact:
          • Mary Lawrence, MD
      • Shelby, North Carolina, United States, 28150
        • Recruiting
        • Shelby Clinical Research, LLC - North Carolina
        • Contact:
          • Christian Martin, MD
    • Ohio
      • Dayton, Ohio, United States, 45424
        • Recruiting
        • Hometown Urgent Care and Research - Dayton
        • Contact:
          • Steve Choi, MD
      • Mason, Ohio, United States, 45040
        • Withdrawn
        • Delricht Research - Concierge Medicine Of Cincinnati
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74133
        • Withdrawn
        • DelRicht Research - Tulsa
    • Pennsylvania
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research
        • Contact:
          • Alan Kivitz, MD
      • West Chester, Pennsylvania, United States, 19380
        • Withdrawn
        • Suburban Research Associates - West Chester Office
    • South Carolina
      • North Charleston, South Carolina, United States, 29405
        • Recruiting
        • Coastal Carolina Research Center - Main
        • Contact:
          • Rica Santiago, MD
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Recruiting
        • Health Concepts
        • Contact:
          • Richard Beasley, MD
    • Tennessee
      • Hendersonville, Tennessee, United States, 37075
        • Withdrawn
        • DelRicht Research - Hendersonville
    • Texas
      • Dallas, Texas, United States, 75230
        • Recruiting
        • Zenos Clinical Research
        • Contact:
          • Durga Tanneru, MD
      • DeSoto, Texas, United States, 75115
        • Recruiting
        • Epic Medical Research - DeSoto
        • Contact:
          • Haresh Boghara, MD
      • Denton, Texas, United States, 76205
        • Recruiting
        • Lone Star Arthritis & Rheumatology Associates - Denton
        • Contact:
          • Awilda (Michelle) Luciano, MD
      • Houston, Texas, United States, 77099
        • Recruiting
        • Pioneer Research Solutions
        • Principal Investigator:
          • Francisco Velazquez, MD
        • Contact:
      • Houston, Texas, United States, 77027
        • Recruiting
        • Prolato Clinical Research Center
        • Contact:
          • Michelle Eisenberg, MD
      • Katy, Texas, United States, 77449
        • Recruiting
        • R & H Clinical Research - Westborough Drive
        • Contact:
          • Maryam Khawari, MD
      • Lewisville, Texas, United States, 75057
        • Recruiting
        • Alliance Clinical Lewisville (Epic Clinical Research)
        • Contact:
          • Manjoo Sharma, MD
      • Mesquite, Texas, United States, 75150
        • Recruiting
        • SouthWest Rheumatology Research
        • Contact:
          • Atul Singhal, MD
      • San Antonio, Texas, United States, 78229
        • Recruiting
        • Discovery Clinical Trials
        • Contact:
          • Abha Gyani, MD
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • ERG - Endeavor Clinical Trials
        • Contact:
          • Nitendra Agarwal, MD
      • Sugar Land, Texas, United States, 77479
        • Recruiting
        • Siena Research Network
        • Contact:
          • Mehjabin Parkar, MD
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research - Tomball - Multiple Specialties
        • Contact:
          • Shaikh Ali, MD
      • Wichita Falls, Texas, United States, 76301
        • Recruiting
        • Digestive Health Research of North Texas
        • Contact:
          • Vanya Wagler, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22911
        • Recruiting
        • Charlottesville Medical Research
        • Contact:
          • James Clark, MD
      • Virginia Beach, Virginia, United States, 23454
        • Recruiting
        • Gershon Pain Specialists
        • Contact:
          • Steven Gershon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Between 18 and 75 years of age (inclusive) at the time of signing informed consent.
  2. Diagnosis of gout based on 2015 American College of Rheumatology (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year.
  3. 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).
  4. 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.
  5. sUA level ≥6.5 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit).
  6. 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.
  7. 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:

  1. History of or presence of kidney stones within 1 year prior to Screening.
  2. History of or presence of malignancy in the last 5 years other than treated cutaneous basal or squamous cell carcinoma.
  3. Hypersensitivity or intolerance to dotinurad or to both colchicine and nonsteroidal anti-inflammatory drugs.
  4. Known or suspected history of drug abuse, a positive drug test at Screening Visit 1, or a recent history of alcohol abuse.
  5. Known history of or positive results for human immunodeficiency virus, Hepatitis B Surface Antigen, or Hepatitis C antibodies during Screening.
  6. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Allopurinol
Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 64.
Drug: Allopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO).
Experimental: Dotinurad 2 mg Maintenance
Participants will discontinue their allopurinol and start dotinurad 1 mg QD for first 4 weeks (Weeks 1-4) and then dotinurad 2 mg QD through Week 64.
Drug: Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Experimental: Dotinurad 4 mg Maintenance
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 through Week 64.
Drug: Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Percentage of Participants With an sUA Level <6.0 mg/dL at Week 24
Time Frame: Week 24
Week 24

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of Participants With an sUA Level <6.0 mg/dL at Weeks 16, 20 and 24 Inclusive
Time Frame: Weeks 16, 20 and 24
Weeks 16, 20 and 24
Mean Rate of Gout Flares Requiring Treatment From Week 36 Through Week 64
Time Frame: Week 36 through Week 64
Week 36 through Week 64
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 64
Time Frame: Week 24 and Week 36 through Week 64
Week 24 and Week 36 through Week 64
Mean Change From Baseline in sUA at Week 24
Time Frame: Baseline and Week 24
Baseline and Week 24
Percentage of Participants who do not Have a Gout Flare Requiring Treatment From Week 24 Through Week 64
Time Frame: Week 24 through Week 64
Week 24 through Week 64
Percentage of Participants With an sUA Level <6.0 mg/dL at Each Visit
Time Frame: Up to Week 68
Up to Week 68
Percentage of Participants With an sUA Level <5.0 mg/dL at Each Visit
Time Frame: Up to Week 68
Up to Week 68
Percentage of Participants With an sUA Level <4.0 mg/dL at Each Visit
Time Frame: Up to Week 68
Up to Week 68
Absolute Change from Baseline in sUA Levels at Each Visit
Time Frame: Baseline to Week 68
Baseline to Week 68
Percent Change from Baseline in sUA Levels at Each Visit
Time Frame: Baseline to Week 68
Baseline to Week 68
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Percentage of Participants With Serious Adverse Events (SAEs)
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Percentage of Participants With a Gout Flare Requiring Treatment at Each Visit Between Week 24 and the end of Study
Time Frame: Week 24 to Week 68
Week 24 to Week 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Crystalys Therapeutics

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 29, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 29, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FYU-981-CRYS-301
  • 2024-520206-19-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant data that underlie the results reported for publication, after deidentification.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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