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Purpose

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.

Condition

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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-European Union League Against Rheumatism (ACR-EULAR) criteria for at least 1 year. 3. 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. 4. sUA level ≥5.0 mg/dL at Screening Visit 1 (Day -35 Visit) and Screening Visit 2 (Day -7 Visit). 5. 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. 6. 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 colchicine and nonsteroidal anti-inflammatory drugs (NSAIDs). 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 (HIV), Hepatitis B Surface Antigen (HBsAg), or Hepatitis C antibodies (HCV) during Screening.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Allopurinol 		Participants will discontinue their allopurinol and start on study-supplied allopurinol at the same dose once a day (QD) through Week 76.
  • Drug: Allopurinol
    Over-encapsulated tablets containing active drug substance administered orally (PO).
Experimental
Dotinurad 		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
    Over-encapsulated tablets containing active drug substance administered PO.

Recruiting Locations

Alabama Clinical Therapeutics
Birmingham, Alabama 35235
Contact:
Gregory Flippo, MD

G & L Research
Foley, Alabama 36535
Contact:
Nidal Morrar, MD

Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert, Arizona 85297
Contact:
Daniel Kreutz, MD

Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale, Arizona 85306
Contact:
Nehad Soloman, MD

Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa, Arizona 85210
Contact:
Swati Bharadwaj, MD

Del Sol Research Management - Tucson East
Tucson, Arizona 85715
Contact:
Vicki Kalen, MD

Medvin Clinical Research - Covina
Covina, California 91722
Contact:
Samy Metyas, MD

West Coast Research
Dublin, California 94568
Contact:
Tim Davis
925-413-1451
tdavis@westcoastresearch.com

Infinity Clinical Research
Norco, California 92860
Contact:
Peter Mattar, MD

Amicis Research Center - Balboa
Northridge, California 91324
Contact:
Pascal Dabel, MD

Dream Team Clinical Research
Pomona, California 91767
Contact:
Quang Vo, MD

East Bay Rheumatology Medical Group
San Leandro, California 94578
Contact:
Suneet Grewal, MD

BTC Network - Encompass Clinical Research
Spring Valley, California 91978
Contact:
Hanid Audish, MD

Cohen Medical Centers
Thousand Oaks, California 91360-3967
Contact:
Shariar Cohen-Gadol, MD

Medvin Clinical Research - Tujunga
Tujunga, California 91042
Contact:
Dan La, MD

Denver Arthritis Clinic - Lowry
Denver, Colorado 80230
Contact:
Christopher Antolini, MD

Bradenton Research Center
Bradenton, Florida 34205
Contact:
Erick Folkens, MD

Herco Medical and Research Center, Inc
Coral Gables, Florida 33134

New Generation of Medical Research
Hialeah, Florida 32016
Contact:
Karelia Ruiz, MD

Best Quality Research
Hialeah, Florida 33016

Health Awareness Inc
Jupiter, Florida 33458
Contact:
Ronald Surowitz, MD

Clinical Research of Center Florida
Lakeland, Florida 33805
Contact:
Michael Gimness, MD

D&H Pompano Research Center
Margate, Florida 33063
Contact:
Mazyar Rouhani, MD

Anchor Medical Research, LLC
Miami, Florida 33176
Contact:
Juvental Martinez, MD

Panax Clinical Research
Miami Lakes, Florida 33014
Contact:
Robert G. Perry, MD

Omega Research DeBary
Orlando, Florida 32808
Contact:
Kwabena Ayesu, MD

Clinical Research Trials of Florida
Tampa, Florida 33607
Contact:
Viviana Fonseca
813-873-8102
viviana@crtfi.com

Conquest Research - Winter Park
Winter Park, Florida 32789
Contact:
Anand Patel, 32789

Chicago Clinical Research Institute, Inc. (CCRII)
Chicago, Illinois 60607
Contact:
Manognya Sama
312-791-3241
manognya@ccrii.us

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago, Illinois 60640
Contact:
Manish Jain, MD

MediSphere Medical Research Center, LLC - East
Evansville, Indiana 47714
Contact:
Hubert Reyes, MD

Delricht Research - Better Life Direct Primary Care
Indianapolis, Indiana 46202

Delricht Research - Concierge And Direct Primary Care
Overland Park, Kansas 66223

DelRicht Research - Louisville (Derby City DPC)
Louisville, Kentucky 40205

Tandem Clinical Research - Metairie Clinic
Metairie, Louisiana 70006
Contact:
David L. Schneider, MD

DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans, Louisiana 70124
Contact:
Emily Krambeck
504-336-2667
ekrambeck@delricht.com

DelRicht Research - Prairieville
Prairieville, Louisiana 70769
Contact:
Brittany Bolton
225-412-0316
bbolton@delricht.com

MD Medical Research - Oxon Hill
Oxon Hill, Maryland 20745
Contact:
Stephen Ong, MD

MedVadis Research
Waltham, Massachusetts 02451
Contact:
David DiBenedetto, MD

A. Alfred Taubman Health Care Center
Ann Arbor, Michigan 48109
Contact:
Puja Khanna, 48109

DM Clinical Research - Detroit
Southfield, Michigan 48076
Contact:
Rebecca Rivard, MD

Revival Research Institute - Sterling Heights
Sterling Heights, Michigan 48313
Contact:
Syed Husain, MD

Oakland Medical Center
Troy, Michigan 48085
Contact:
Jay Sandberg, MD

Delricht Research - Command Family Medicine
Springfield, Missouri 65807

DelRicht Research - Town and Country
Town and Country, Missouri 63017

Las Vegas Clinical Trials
North Las Vegas, Nevada 89030
Contact:
Alton Walters, MD

Ellipsis Research Group
Brooklyn, New York 11215
Contact:
Jorge Serje, MD

New York University Langone Orthopedic Center
New York, New York 10016
Contact:
Michael Pillinger, MD

DelRicht Research - Charlotte (Direct Primary Care - DPC)
Charlotte, North Carolina 28205

Shelby Clinical Research, LLC - North Carolina
Shelby, North Carolina 28150

Hometown Urgent Care and Research - Dayton
Dayton, Ohio 45424
Contact:
Steve Choi, MD

Delricht Research - Concierge Medicine Of Cincinnati
Mason, Ohio 45040

Suburban Research Associates - West Chester Office
West Chester, Pennsylvania 19380
Contact:
Omer Abdullah, MD

Coastal Carolina Research Center - Main
North Charleston, South Carolina 29405
Contact:
Rica Santiago, MD

Health Concepts
Rapid City, South Dakota 57702
Contact:
Richard Beasley, MD

DelRicht Research - Hendersonville
Hendersonville, Tennessee 37075

Arthritis & Osteoporosis Center of Coastal Bend
Corpus Christi, Texas 78415
Contact:
Eric Chiang, MD

Zenos Clinical Research
Dallas, Texas 75230

Lone Star Arthritis & Rheumatology Associates - Denton
Denton, Texas 76205
Contact:
Awilda (Michelle) Luciano, MD

Epic Medical Research - DeSoto
DeSoto, Texas 75115
Contact:
Haresh Boghara, MD

Prolato Clinical Research Center
Houston, Texas 77027
Contact:
Michelle Eisenberg, MD

Pioneeer Research Solutions
Houston, Texas 77099
Contact:
Mozaffari Shahin
713-333-9323
shahin@pioneerresearchsolutions.com

R & H Clinical Research - South Fry Road
Katy, Texas 77450
Contact:
Maryam Khawari, MD

Premise Clinical Research Center
Lancaster, Texas 75146
Contact:
Josier Nisnisan, MD

Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville, Texas 75057

Southwest Rheumatology Research
Mesquite, Texas 75150
Contact:
Atul Singhal, MD

Discovery Clinical Trials
San Antonio, Texas 78229

ERG - Endeavor Clinical Trials
San Antonio, Texas 78240
Contact:
Nitendra Agarwal, MD

Siena Research Network
Sugar Land, Texas 77479
Contact:
Mehjabin Parkar, MD

DM Clinical Research - Tomball - Multiple Specialties
Tomball, Texas 77375
Contact:
Shaikh Ali, MD

Rio Clinical Trials - Corporate Office
Ogden, Utah 84404
Contact:
Stephen Bruce, MD

Charlottesville Medical Research
Charlottesville, Virginia 22911
Contact:
James Clark, MD

Gershon Pain Specialists
Virginia Beach, Virginia 23454
Contact:
Stephen Gershon, MD

More Details

Status
Recruiting
Sponsor
Crystalys Therapeutics

Study Contact

Clinical Trial Lead
(858) 356-4740
ClinicalTrials@crystalystx.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.