Health TrialsbyHealthPanel

A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

ConditionTophaceous Gout
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-75
SponsorCrystalys Therapeutics

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Allopurinol

    Drug

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

  • Dotinurad

    Drug

    Over-encapsulated tablets containing active drug substance administered PO.

Treatment groups

250 Participants
are divided into 2 treatment groups
Group A: AllopurinolActive comparator 1 intervention
Group B: DotinuradExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

Time frame
Week 24

Secondary outcomes

1

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

Time frame
Week 76
2

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

Time frame
Week 76
3

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

Time frame
Week 24
4

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

Time frame
Week 36 through Week 76

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Crystalys Therapeutics

Lead sponsor

Source ClinicalTrials.gov
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