A Study of Dotinurad Versus Allopurinol in Tophaceous Gout

Recruiting Phase 3 Interventional Study
Tophaceous Gout
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 – 75
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
250 (estimated)
Sponsor
Crystalys Therapeutics · Industry
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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.

Trial Locations
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Eligibility Criteria
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/w…
Contacts

Clinical Trial Lead

1-858-379-2316

ClinicalTrials@crystalystx.com

CONTACT