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NCT05690204 · ClinicalTrials.gov registry record · Phase 2
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
A Phase 2 study of Gout, sponsored by Shanton Pharma Pte..
- Active
- Registry status
- Phase 2
- Development phase
- 87
- Enrollment target
- 16
- Study locations
NCT05690204: Active Phase 2 study of Gout, sponsored by Shanton Pharma Pte..
NCT05690204 is a Phase 2 study of Gout that is active but no longer recruiting, run by Shanton Pharma Pte.. The registered enrollment target is 87 participants, below the 8,886-participant average among 34 other Gout trials with a reported enrollment target (99% lower). The trial reports 16 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05690204, a Phase 2 study of Gout, is active but no longer recruiting, sponsored by Shanton Pharma Pte..
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 87 participants
- Enrollment target
- 16
- Study locations
Study Summary
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 Outcome
assess the proportion of subjects who achieved sUA levels less than 6 mg/dl by laboratory results
Conditions Studied
Interventions
- DRUG SAP-001
Study Locations (16)
Florida
- Florida Site - DeBary
- Florida Site - Miami
- Florida Site - Miami Lakes
- Florida Site - Miami Lakes
- Florida Site - Winter Park
Texas
- Texas Site - Mesquite
- Texas Site - Plano
- Texas Site - The Woodlands
California
- California Site - Sacramento
- California Site - San Diego
Colorado
- Denver Site - Denver
Idaho
- Idaho Site - Boise
Maryland
- Maryland Site - Oxon Hill
Mississippi
- Mississippi Site - Jackson
North Carolina
- North Carolina Site - Raleigh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2022-12-12 |
| Est. Completion | 2025-02 |
| Phase | Phase 2 |
What the registry record for NCT05690204 still lists
NCT05690204 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 8,886-participant average among 34 other Gout trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Gout appearing as the primary indexed condition, and to 1 intervention - of which SAP-001 is the first listed.
NCT05690204 lists 16 locations in 9 states (Florida, Texas, California).
Frequently Asked Questions
What is clinical trial NCT05690204 about?
NCT05690204 is a clinical study titled "Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.". 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...
What is the current status of trial NCT05690204?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 87 participants. The study started on 2022-12-12. Estimated completion is 2025-02.
What conditions does trial NCT05690204 study?
This clinical trial studies the following conditions: Gout.
What interventions are being tested in trial NCT05690204?
The interventions under investigation include: SAP-001 (DRUG).
Who is sponsoring clinical trial NCT05690204?
This trial is sponsored by Shanton Pharma Pte., which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05690204 being conducted?
This trial has 16 study locations across California, Colorado, Florida, Idaho, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Gout
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05690204's enrollment target sits among peer trials
87 18th of 34 higher than 17 of 34 other Gout trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Gout trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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