SAP001 for Gout

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, SAP001, for individuals with gout, particularly those not finding relief with their current XOI therapy. Researchers seek to determine if SAP001 lowers uric acid levels and reduces tophi (lumps caused by gout). Participants will receive either a placebo or varying doses of SAP001 to identify the optimal dose for future studies. This trial may suit those who have experienced gout attacks at least three times in the last 18 months or have a visible gout lump and are not responding to or cannot take standard gout treatments. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that SAP-001 was well tolerated in earlier studies for treating gout and high uric acid levels. In these studies, patients took single doses up to 120 mg and daily doses up to 60 mg for 28 days without major safety concerns. This suggests that SAP-001 is generally safe for humans, at least in the short term. No serious side effects were reported, which is encouraging for those considering participation in a clinical trial with SAP-001. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for gout?

Researchers are excited about SAP001 for gout because it offers a potential new way to manage the condition. Unlike the standard treatments that typically focus on reducing uric acid levels, SAP001 targets the inflammatory response specifically associated with gout flares. This unique mechanism could provide faster relief from painful symptoms. Additionally, SAP001 is being tested in varying doses, which might help tailor treatment more precisely to patients' needs, potentially leading to better outcomes with fewer side effects.

What evidence suggests that this trial's treatments could be effective for gout?

Research has shown that SAP-001 holds promise for treating gout, particularly in patients unresponsive to standard treatments. In earlier studies, over half of the patients taking 60 mg of SAP-001 daily experienced a significant reduction in uric acid levels. After three months, nearly all patients on either 30 mg or 60 mg doses achieved uric acid levels below 6 mg/dL, a crucial target for managing gout. This trial will evaluate various doses of SAP-001, including low, middle, and high doses, alongside a placebo. These findings suggest that SAP-001 could effectively manage gout symptoms and lower uric acid levels in patients who have not found success with other treatments. ^{1 2 3 6 7}

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.

My kidney function is reduced, with specific test results.

I have never been diagnosed with gout before my screening visit.

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+

Citations

1. the-rheumatologist.org the-rheumatologist.org/article/sap-001-promising-for-refractory-gout/

SAP-001 Promising for Refractory Gout Most effects lasted through month 6, the end of the study. Of the patients who received 60 mg of SAP-001 daily, more than half achieved a serum ...

2. hcplive.com hcplive.com/view/sap-001-demonstrates-best-in-class-data-gout-hyperuricemia-refractory-soc-xoi-therapy

SAP-001 Demonstrates “Best in Class” Data for Gout With ... By 3 months, nearly all patients confirmed exposed to 30 or 60 mg SAP-001 reached serum uric acid levels below 6mg/dL.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04040816

NCT04040816 | Placebo Controlled, Multiple Dose Study ... Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients. ClinicalTrials.gov ...

4. biospace.com biospace.com/press-releases/shanton-reveals-topline-data-from-phase-2b-study-in-refractory-gout-patients

Shanton Reveals Topline Data from Phase 2b Study in ... The Primary objective is to assess the effectiveness of SAP-001 in lowering serum urate levels in gout patients that are refractory to ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003496725014281

LB0008 SAP-001, A FIRST –IN-CLASS COMPOUND ... Among patients exposed to study drug, SAP-001 demonstrated robust, sustained urate-lowering effect in refractory gout patients with or without palpable tophi. A ...

6. renalandurologynews.com renalandurologynews.com/news/novel-oral-therapy-for-uncontrolled-gout-gets-fast-track-designation/

Novel Oral Therapy for Uncontrolled Gout Gets Fast Track ... SAP-001 is an investigational oral agent designed to reduce serum uric acid levels by targeting a distinct renal urate reabsorption transporter.

7. ctv.veeva.com ctv.veeva.com/study/dose-finding-study-to-evaluate-safety-and-efficacy-of-3-dosages-of-sap001

Dose Finding Study to Evaluate Safety and Efficacy of 3 ... 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 ...