A Phase 2 Trial of Dotinurad in Xanthine Oxidase Inhibitor (XOI) Intolerant/Uricase Failure Gout Participants
Recruiting
Phase 2
Interventional Study
Gout
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Any
- Trial phase
- Phase 2
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 90 (estimated)
- Sponsor
- Crystalys Therapeutics · Industry
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About This Trial
The primary objective of this trial is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 in participants with gout who are XOI intolerant or have failed uricase treatment.
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 (ACR)-European Union League Against Rheumatism (EULAR) criteria for at least 1 year and has at least 1 of the following:
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Contacts