A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

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

  • Tophaceous Gout

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 4049979, Alabama 4829764 35235
Contact:
Gregory Flippo, MD

Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert
Gilbert 5295903, Arizona 5551752 85297
Contact:
Daniel Kreutz, MD

Arizona Arthritis & Rheumatology Associates (AARA) - Glendale
Glendale 5295985, Arizona 5551752 85306
Contact:
Nehad Soloman, MD

Arizona Arthritis & Rheumatology Associates (AARA) - Mesa
Mesa 5304391, Arizona 5551752 85210
Contact:
Swati Bharadwaj, MD

Del Sol Research Management - Tucson East
Tucson 5318313, Arizona 5551752 85715
Contact:
Vicki Kalen, MD

Medvin Clinical Research - Covina
Covina 5340175, California 5332921 91722
Contact:
Samy Metyas, MD

West Coast Research
Dublin 5344157, California 5332921 94568
Contact:
Tim Davis
925-413-1451
tdavis@westcoastresearch.com

Infinity Clinical Research
Norco 5377199, California 5332921 92860
Contact:
Peter Mattar, MD

Amicis Research Center - Balboa
Northridge 5377985, California 5332921 91324
Contact:
Pascal Dabel, MD

Dream Team Clinical Research
Pomona 5384170, California 5332921 91767
Contact:
Quang Vo, MD

East Bay Rheumatology Medical Group
San Leandro 5392263, California 5332921 94578
Contact:
Suneet Grewal, MD

BTC Network - Encompass Clinical Research
Spring Valley 5398277, California 5332921 91978
Contact:
Hanid Audish, MD

Cohen Medical Centers
Thousand Oaks 5402405, California 5332921 91360-3967
Contact:
Shariar Cohen-Gadol, MD

Medvin Clinical Research - Tujunga
Tujunga 5403767, California 5332921 91042
Contact:
Dan La, MD

Denver Arthritis Clinic - Lowry
Denver 5419384, Colorado 5417618 80230
Contact:
Christopher Antolini, MD

Bradenton Research Center
Bradenton 4148708, Florida 4155751 34205
Contact:
Erick Folkens, MD

Herco Medical and Research Center, Inc
Coral Gables 4151871, Florida 4155751 33134

New Generation of Medical Research
Hialeah 4158476, Florida 4155751 32016
Contact:
Karelia Ruiz, MD

Best Quality Research
Hialeah 4158476, Florida 4155751 33016

Health Awareness Inc
Jupiter 4160610, Florida 4155751 33458
Contact:
Ronald Surowitz, MD

Clinical Research of Center Florida
Lakeland 4161438, Florida 4155751 33805
Contact:
Michael Gimness, MD

D&H Pompano Research Center
Margate 4163407, Florida 4155751 33063
Contact:
Mazyar Rouhani, MD

Anchor Medical Research, LLC
Miami 4164138, Florida 4155751 33176
Contact:
Juvental Martinez, MD

Panax Clinical Research
Miami Lakes 4164186, Florida 4155751 33014
Contact:
Robert G. Perry, MD

Omega Research DeBary
Orlando 4167147, Florida 4155751 32808
Contact:
Kwabena Ayesu, MD

Clinical Research Trials of Florida
Tampa 4174757, Florida 4155751 33607
Contact:
Viviana Fonseca
813-873-8102
viviana@crtfi.com

DelRicht Research - Atlanta
Atlanta 4180439, Georgia 4197000 30329

Chicago Clinical Research Institute, Inc. (CCRII)
Chicago 4887398, Illinois 4896861 60607
Contact:
Manognya Sama
312-791-3241
manognya@ccrii.us

Flourish Chicago - Ravenswood (Great Lakes Clinical Trials)
Chicago 4887398, Illinois 4896861 60640
Contact:
Manish Jain, MD

MediSphere Medical Research Center, LLC - East
Evansville 4257227, Indiana 4921868 47714
Contact:
Hubert Reyes, MD

Delricht Research - Better Life Direct Primary Care
Indianapolis 4259418, Indiana 4921868 46202

Delricht Research - Concierge And Direct Primary Care
Overland Park 4276873, Kansas 4273857 66223

DelRicht Research - Louisville (Derby City DPC)
Louisville 4299276, Kentucky 6254925 40205

Tandem Clinical Research - Metairie Clinic
Metairie 4333177, Louisiana 4331987 70006
Contact:
David L. Schneider, MD

DelRicht Research - LCMC Health Urgent Care - Lakeview
New Orleans 4335045, Louisiana 4331987 70124
Contact:
Emily Krambeck
504-336-2667
ekrambeck@delricht.com

DelRicht Research - Prairieville
Prairieville 4338012, Louisiana 4331987 70769
Contact:
Brittany Bolton
225-412-0316
bbolton@delricht.com

MD Medical Research - Oxon Hill
Oxon Hill 4364759, Maryland 4361885 20745
Contact:
Stephen Ong, MD

DelRicht Research - Maryland (Matthew L. Mintz, MD, FACP)
Rockville 4367175, Maryland 4361885 20852

MedVadis Research
Waltham 4954380, Massachusetts 6254926 02451
Contact:
David DiBenedetto, MD

A. Alfred Taubman Health Care Center
Ann Arbor 4984247, Michigan 5001836 48109
Contact:
Puja Khanna, 48109

DM Clinical Research - Detroit
Southfield 5010636, Michigan 5001836 48076
Contact:
Rebecca Rivard, MD

Oakland Medical Center
Troy 5012639, Michigan 5001836 48085
Contact:
Jay Sandberg, MD

Delricht Research - Command Family Medicine
Springfield 4409896, Missouri 4398678 65807

DelRicht Research - Town and Country
Town and Country 4411912, Missouri 4398678 63017

Las Vegas Clinical Trials
North Las Vegas 5509403, Nevada 5509151 89030
Contact:
Alton Walters, MD

Ellipsis Research Group
Brooklyn 5110302, New York 5128638 11215
Contact:
Jorge Serje, MD

New York University Langone Orthopedic Center
New York 5128581, New York 5128638 10016
Contact:
Michael Pillinger, MD

DelRicht Research - Charlotte (Direct Primary Care - DPC)
Charlotte 4460243, North Carolina 4482348 28205

Shelby Clinical Research, LLC - North Carolina
Shelby 4491180, North Carolina 4482348 28150

Hometown Urgent Care and Research - Dayton
Dayton 4509884, Ohio 5165418 45424
Contact:
Steve Choi, MD

Delricht Research - Concierge Medicine Of Cincinnati
Mason 4517698, Ohio 5165418 45040

DelRicht Research - Tulsa
Tulsa 4553433, Oklahoma 4544379 74133

Suburban Research Associates - West Chester Office
West Chester 4562144, Pennsylvania 6254927 19380
Contact:
Omer Abdullah, MD

Coastal Carolina Research Center - Main
North Charleston 4589387, South Carolina 4597040 29405
Contact:
Rica Santiago, MD

Health Concepts
Rapid City 5768233, South Dakota 5769223 57702
Contact:
Richard Beasley, MD

DelRicht Research - Hendersonville
Hendersonville 4628735, Tennessee 4662168 37075

Zenos Clinical Research
Dallas 4684888, Texas 4736286 75230

Lone Star Arthritis & Rheumatology Associates - Denton
Denton 4685907, Texas 4736286 76205
Contact:
Awilda (Michelle) Luciano, MD

Epic Medical Research - DeSoto
DeSoto 4685524, Texas 4736286 75115
Contact:
Haresh Boghara, MD

Prolato Clinical Research Center
Houston 4699066, Texas 4736286 77027
Contact:
Michelle Eisenberg, MD

Pioneeer Research Solutions
Houston 4699066, Texas 4736286 77099
Contact:
Mozaffari Shahin
713-333-9323
shahin@pioneerresearchsolutions.com

Alliance Clinical Lewisville (Epic Clinical Research)
Lewisville 4706057, Texas 4736286 75057

Southwest Rheumatology Research
Mesquite 4710826, Texas 4736286 75150
Contact:
Atul Singhal, MD

Discovery Clinical Trials
San Antonio 4726206, Texas 4736286 78229

ERG - Endeavor Clinical Trials
San Antonio 4726206, Texas 4736286 78240
Contact:
Nitendra Agarwal, MD

DM Clinical Research - Tomball - Multiple Specialties
Tomball 4737094, Texas 4736286 77375
Contact:
Shaikh Ali, MD

Charlottesville Medical Research
Charlottesville 4752031, Virginia 6254928 22911
Contact:
James Clark, MD

More Details

Status
Recruiting
Sponsor
Crystalys Therapeutics

Study Contact

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