What side effects are associated with this type of intervention?

Common treatments for gout that lower serum uric acid levels and reduce tophus burden include allopurinol, febuxostat, and topiroxostat. Allopurinol can cause side effects such as rash, gastrointestinal upset, and, rarely, severe hypersensitivity reactions. Febuxostat may lead to liver function abnormalities, nausea, and an increased risk of cardiovascular events. Topiroxostat is generally well-tolerated but can cause mild side effects like liver enzyme elevation and gastrointestinal discomfort. Patients should discuss these potential side effects with their healthcare provider to determine the most appropriate treatment.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of gout that lower serum uric acid levels and reduce tophus burden. Allopurinol, a xanthine oxidase inhibitor (XOI), is commonly used as a first-line therapy. Febuxostat, another XOI, is also approved and has shown efficacy in maintaining lower serum urate levels, although it has been associated with higher cardiovascular risks. Pegloticase, a polyethylene glycol-conjugated uricase enzyme, is approved for chronic gout refractory to conventional therapy and has demonstrated significant reductions in serum uric acid and tophi. These treatments align with the goals of SAP-001 in managing hyperuricemia and tophaceous gout.

What other types of research exist?

Promising novel alternatives to SAP-001 for gout patients include topiroxostat and febuxostat. Topiroxostat has shown effective SUA reduction and potential renoprotective effects in hyperuricemic patients with chronic kidney disease (CKD). Febuxostat has also demonstrated efficacy in improving renal function in a subgroup of CKD patients with hyperuricemia. Both medications may offer benefits in managing gout and associated conditions.

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Unknown

SAP001 for Gout

Phase 2

Waitlist Available

Research Sponsored by Shanton Pharma Pte. Ltd.

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 24 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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).

What is being tested?

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.

What are the potential side effects?

While the specific side effects of SAP001 are not listed here, similar medications often cause digestive problems, skin reactions, liver issues, and may affect kidney function. Participants will be monitored for any adverse reactions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 24 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~24 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 24 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

primary

Secondary study objectives

Change from Baseline on PE measure

Changes from Baseline on ECGs

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAP-001

2023

Completed Phase 2

~140

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for gout, such as allopurinol and febuxostat, primarily work by inhibiting xanthine oxidase, an enzyme involved in the production of uric acid. By reducing the synthesis of uric acid, these medications lower serum uric acid levels, which helps prevent the formation of urate crystals and reduces the size of tophi, the painful deposits of uric acid in joints and tissues. This is crucial for gout patients as it alleviates pain, reduces the frequency of gout flares, and prevents long-term joint damage. Other treatments may enhance uric acid excretion through the kidneys, further aiding in the management of hyperuricemia and its complications.

Prevention of kidney function decline using uric acid-lowering therapy in chronic kidney disease patients: a systematic review and network meta-analysis.Recent approaches to gout drug discovery: an update.Lack of effect of tart cherry concentrate dose on serum urate in people with gout.