Recruiting NCT07089888
A Study of Dotinurad Versus Allopurinol in Tophaceous Gout
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Allopurinol, Dotinurad.
- Who it may be relevant to
- Registry conditions: Tophaceous Gout. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Phase 3, Randomized, Double-Blind, Multicenter Study to Evaluate the Efficacy and Safety of Dotinurad Compared With Allopurinol in Adult Participants With Tophaceous Gout
Overview
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.
Interventions
- Drug Allopurinol
Over-encapsulated tablets containing active drug substance administered orally (PO). - Drug Dotinurad
Over-encapsulated tablets containing active drug substance administered PO.
Primary outcome measures
- Percentage of Participants with an sUA Level <5.0 mg/dL at Week 24 [Time frame: Week 24]
Secondary outcome measures (12)
- Percentage of Participants who Experience Complete Response (CR) or Partial Response (PR) of ≥1 Target Tophus at Week 76 [Time frame: Week 76]
- Percentage of Participants who Experience CR of ≥1 Target Tophus at Week 76 [Time frame: Week 76]
- Percentage of Participants with an sUA Level <4.0 mg/dL at Week 24 [Time frame: Week 24]
- Mean Rate of Gout Flares Requiring Treatment from Week 36 Through Week 76 [Time frame: 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 [Time frame: Week 24 and Week 36 through Week 76]
- Mean Change from Baseline in sUA at Week 24 [Time frame: Baseline and Week 24]
- Mean Percent Change from Baseline in the Sum of the Areas for all Target Tophi at Each Visit [Time frame: Baseline to Week 80]
- Percentage of Participants who Do Not have a Gout Flare Requiring Treatment from Week 36 through Week 76 [Time frame: Week 36 through Week 76]
- Percentage of Participants with an sUA Level <5.0 mg/dL at Each Visit [Time frame: Up to Week 80]
- Percentage of Participants with an sUA Level <4.0 mg/dL at Each Visit [Time frame: Up to Week 80]
- Percentage of Participants with an sUA Level <3.0 mg/dL at Each Visit [Time frame: Up to Week 80]
- Absolute Change from Baseline in sUA Levels at Each Visit [Time frame: Baseline to Week 80]
Eligibility 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-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.
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 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 89 centers
- The Kirklin Clinic of University of Alabama Birmingham Hospital — Birmingham
- Alabama Clinical Therapeutics — Birmingham
- G & L Research — Foley
- Arizona Arthritis & Rheumatology Associates (AARA) - Gilbert — Gilbert
- Arizona Arthritis & Rheumatology Associates (AARA) - Glendale — Glendale
- Arizona Arthritis & Rheumatology Associates (AARA) - Mesa — Mesa
- Del Sol Research Management - Tucson East — Tucson
- Medvin Clinical Research - Covina — Covina
- … and 81 more centers
Identifiers
NCT: NCT07089888 · FYU-981-CRYS-302 · 2024-520207-84-00