NCT05690204

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

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 87 (actual)
• Sponsor: Shanton Pharma Pte. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

A Phase 2B, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to assess the safety, PK, PD, and efficacy of 3 orally administered dosages of SAP-001 compared to placebo QD in adult subjects with gout, with or without tophi, and hyperuricemia refractory to standard-of-care (SoC) XOI therapy. In the completed Phase 1 and Phase 2 studies, SAP-001 was well tolerated at single doses up to 120 mg and at dosages up to 60 mg QD for 28-days in subjects with gout and hyperuricemia and demonstrated statistically significant reductions in sUA levels compared to placebo. The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001.

Conditions

• Gout

Interventions

Type	Name	Description
DRUG	SAP-001	Test the efficacy and safety of SAP-001 versus placebo

Timeline

• Start date: 2022-12-12
• Primary completion: 2025-01-01
• Completion: 2025-02-01
• First posted: 2023-01-19
• Last updated: 2024-11-14

Locations

16 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study