SAP001 second study drug group for Gout

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
GoutSAP001 - Drug
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 3 Secondary · Reporting Duration: 24 weeks

24 weeks
AE
Change from Baseline on PE measure
Changes from Baseline on ECGs
primary

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

Colchicine
1%Chest pain
1%Ischemic stroke
This histogram enumerates side effects from a completed 2021 Phase 4 trial (NCT01709981) in the Colchicine ARM group. Side effects include: Chest pain with 1%, Ischemic stroke with 1%.

Trial Design

4 Treatment Groups

SAP001 second study drug group
1 of 4
SAP001 third study drug group
1 of 4
Placebo versus SAP 001
1 of 4
SAP001 first study drug group
1 of 4

Experimental Treatment

80 Total Participants · 4 Treatment Groups

Primary Treatment: SAP001 second study drug group · No Placebo Group · Phase 2

SAP001 second study drug group
Drug
Experimental Group · 1 Intervention: SAP001 · Intervention Types: Drug
SAP001 third study drug group
Drug
Experimental Group · 1 Intervention: SAP001 · Intervention Types: Drug
Placebo versus SAP 001
Drug
Experimental Group · 1 Intervention: SAP001 · Intervention Types: Drug
SAP001 first study drug group
Drug
Experimental Group · 1 Intervention: SAP001 · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Shanton Pharma Co., Ltd.Lead Sponsor
2 Previous Clinical Trials
64 Total Patients Enrolled
2 Trials studying Gout
64 Patients Enrolled for Gout
Celina Cabale-SchollStudy DirectorShanton Pharma

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You must be a male or female aged between 18 and 65 years old, who is able to understand the requirements of the protocol and agree to them.
You have a body mass index between 19 and 40 kg/m2, you are diagnosed with symptomatic gout according to the American College of Rheumatology criteria or you've had at least three gout flares in the last 18 months, one tophus or gouty arthritis, your uric acid levels haven't normalized after treatment on XOI therapy for at least 3 months at maximum medically appropriate dose or there is a medical contraindication that prevents taking this medication, and SoC XOI therapy isn't considered an appropriate option.
You have been on SoC XOI therapy for gout and hyperuricemia for a minimum of 4 weeks prior to the Randomization Visit, unless contraindicated or not medically appropriate.
Your sUA levels must be at least 7.5 mg/dL when you are screened and randomized.