87 Participants Needed

SAP001 for Gout

Recruiting at 23 trial locations
CC
CA
SC
CA
SC
Overseen ByShanshan Cui, PhD
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: Shanton Pharma Pte. Ltd.
Must be taking: XOI therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

This trial is testing SAP-001, a new oral medication, in adults with gout who haven't responded to standard treatments. The goal is to see if it can safely lower uric acid levels and reduce painful lumps caused by gout.

Will I have to stop taking my current medications?

The trial requires that you stop taking any medications known to lower uric acid levels, except for standard XOI therapies, at least 14 days before starting the trial. However, if you are taking losartan for blood pressure and have been on a stable dose for at least 6 months, you can continue using it.

Research Team

CA

Carmen Arencibia

Principal Investigator

Study Official

Eligibility Criteria

Adults aged 18-65 with gout, BMI between 19 and 40, who have high uric acid levels despite taking standard gout medication (unless not suitable), can join this trial. They mustn't have chronic liver issues or recent use of certain uric acid-lowering drugs (except stable losartan users).

Inclusion Criteria

Subject must have serum uric acid (sUA) levels ≥7.0 mg/dL by central laboratory results at the Screening Visit (Visit 1) and prior to randomization at the Randomization Visit (Day 1, Visit 4)
I have been on standard gout treatment for at least 4 weeks unless it was not suitable for me.
I am between 18 and 75 years old and agree to follow the study rules.
See 2 more

Exclusion Criteria

My gout flare-up hasn't improved in the last 14 days.
I have never been diagnosed with gout before my screening visit.
My kidney function is reduced, with specific test results.
See 3 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive one of three dosages of SAP-001 or placebo daily for 24 weeks

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • SAP001
Trial OverviewThe study is testing three different doses of a new drug called SAP001 to see how safe it is and how well it works in lowering uric acid and reducing gout-related lumps compared to the usual treatment for people whose gout isn't controlled by standard meds.
Participant Groups
4Treatment groups
Experimental Treatment
Group I: SAP-001 middle doseExperimental Treatment1 Intervention
SAP-001 middle dose
Group II: SAP-001 low doseExperimental Treatment1 Intervention
SAP-001 low dose
Group III: SAP-001 high doseExperimental Treatment1 Intervention
SAP-001 high dose
Group IV: Placebo versus SAP-001Experimental Treatment1 Intervention
Placebo arm

Find a Clinic Near You

Who Is Running the Clinical Trial?

Shanton Pharma Pte. Ltd.

Lead Sponsor

Trials
2
Recruited
120+

Shanton Pharma Co., Ltd.

Lead Sponsor

Trials
4
Recruited
220+