SAP001 for Gout

Recruiting at 23 trial locations

Overseen By Shanshan Cui, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Shanton Pharma Pte. Ltd.

Must be taking: XOI therapy

Must not be taking: Losartan, Pegloticase, URAT1 inhibitors

Disqualifiers: Pregnancy, Non-gout diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

87 Participants Needed

What You Need to Know Before You Apply

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.

Who Is on the Research Team?

Carmen Arencibia

Principal Investigator

Study Official

Are You a Good Fit for This Trial?

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.

Body mass index ≥19 and ≤40 kg/m2 at the Screening Visit (Visit 1)

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.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• SAP001

Trial Overview The 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.

How Is the Trial Designed?

Group I: SAP-001 middle dose Experimental Treatment 1 Intervention

SAP-001 middle dose

Group II: SAP-001 low dose Experimental Treatment 1 Intervention

SAP-001 low dose

Group III: SAP-001 high dose Experimental Treatment 1 Intervention

SAP-001 high dose

Group IV: Placebo versus SAP-001 Experimental Treatment 1 Intervention

Placebo arm

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+