Phase 2Active, not recruiting
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
A Phase 2B Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of 3 Dosages of SAP-001 in Combination With Standard of Care in Adult Subjects With Gout
- Sponsor
- Shanton Pharma Pte. Ltd. (Industry)
- Enrolment
- 87 enrolled
- Conditions
- Gout
- Interventions
- SAP-001
- Ages
- adults, older adults
- Registry
- NCT05690204
Full record on ClinicalTrials.gov
From the registry
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001, evaluate its efficacy in lowering sUA and tophus burden, and identify the appropriate dose regimen for future studies in adult subjects with gout, with or without tophi, and hyperuricemia refractory to SoC XOI therapy.
Primary outcomes
- primary
History
Study completion
Primary completion
Last registry update
Registered
Started