Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001. (NCT05690204)
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
🩺 Plain-English Summary (8th-Grade Level)
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.
Who can join: Review the eligibility criteria below.
Location: California Site — Sacramento, California
Age range: 18 Years to 75 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (16 Sites)
- California Site — Sacramento, California
- California Site — San Diego, California
- Denver Site — Denver, Colorado
- Florida Site — DeBary, Florida
- Florida Site — Miami, Florida
- Florida Site — Miami Lakes, Florida
- Florida Site — Miami Lakes, Florida
- Florida Site — Winter Park, Florida
- Idaho Site — Boise, Idaho
- Maryland Site — Oxon Hill, Maryland
- Mississippi Site — Jackson, Mississippi
- North Carolina Site — Raleigh, North Carolina
- Texas Site — Mesquite, Texas
- Texas Site — Plano, Texas
- Texas Site — The Woodlands, Texas
- Puerto Rico Site — San Juan,
💰 Cost, Insurance & Patient Rights
- 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
- Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
- Voluntary Participation: You may withdraw at any time without affecting your standard medical care.
More studies in Gout
- Assessing the Role of the NLRP3 Inflammasome in Intercritical Gout — Beverly Hills, California
- Gout in the ED and Improving Research Participation — Birmingham, Alabama
- Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients — Margate, Florida
- PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function — Tampa, Florida
- Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301) — Birmingham, Alabama
Explore by condition: All Gout clinical trials
💡 How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.