Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.

• ClinicalTrials.gov Identifier: NCT05690204
• Recruitment Status: Recruiting
• First Posted: January 19, 2023
• Last Update Posted: February 9, 2024
• Sponsor: Shanton Pharma Co., Ltd.
• Information provided by (Responsible Party): Shanton Pharma Co., Ltd.

Tracking Information

• First Submitted Date: December 12, 2022
• First Posted Date: January 19, 2023
• Last Update Posted Date: February 9, 2024
• Actual Study Start Date: December 12, 2022
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: January 9, 2023)

primary [ Time Frame: 24 weeks ]

assess the proportion of subjects who achieved sUA levels less than 6 mg/dl by laboratory results

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: January 9, 2023)

• AE [ Time Frame: 24 weeks ]
  Incidence of AEs including SAE and TEAEs by CTCAE criteria
• Change from Baseline on PE measure [ Time Frame: 24 weeks ]
  Changes from baseline in Physical Exam based on number of participants with abnormal findings
• Changes from Baseline on ECGs [ Time Frame: 24 weeks ]
  Changes from baseline in ECG parameters by QTc intervals

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
• Official Title: A Phase 2B Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of 3 Dosages of SAP-001 in Combination With Standard of Care in Adult Subjects With Gout
• Brief 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.

Detailed Description

A Phase 2B, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to assess the safety, PK, PD, and efficacy of 3 orally administered dosages of SAP-001 (10 mg QD, 30 mg QD, and 60 mg QD) compared to placebo QD in adult subjects with gout, with or without tophi, and hyperuricemia refractory to standard-of-care (SoC) XOI therapy. 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 in subjects with gout and hyperuricemia and demonstrated statistically significant reductions in sUA levels compared to placebo.

The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001

• Study Type: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Gout

Intervention

Drug: SAP001

Test the efficacy and safety of SAP 001 versus placebo

Other Names:

• Xanthine Oxidase Inhibitor
• Colchicine

Study Arms

• Experimental: Placebo versus SAP 001
  Placebo arm
  Intervention: Drug: SAP001
• Experimental: SAP001 10 mg
  SAP001 10 mg
  Intervention: Drug: SAP001
• Experimental: SAP001 30 mg
  SAP001 30mg
  Intervention: Drug: SAP001
• Experimental: SAP001 60 mg
  SAP001 60 mg
  Intervention: Drug: SAP001

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: January 9, 2023): 80
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: January 30, 2025
• Estimated Primary Completion Date: December 30, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Main Inclusion Criteria:

1. Male or female, ≥18 and ≤75 years of age, willing and able to provide informed consent and to adhere to the requirements and guidelines of the protocol.
2. Body mass index ≥19 and ≤40 kg/m2 at the Screening Visit (Visit 1).
3. Already have been diagnosed with gout according to the current American College of Rheumatology (ACR) scoring criteria for the classification of primary gout; or has symptoms of gout with at least 1 of the following: i. 3 gout flares in the previous 18 months prior to screening; or ii. Presence of at least 1 gout tophus; or iii. Current diagnosis of gouty arthritis; Subject must be refractory to SoC XOI therapy, or in whom XOI is contraindicated. Refractory to SOC XOI is defined by a medical history of failure to normalize sUA to <6 mg/dL (the ACR target for gout) with at least 3 months of SoC XOI treatment at the maximum medically appropriate dose. XOI contraindication can be self-reported medical contraindication to SoC XOI therapy or in whom SoC XOI therapy is not considered medically appropriate treatment for symptomatic gout. Subject can still participate in the clinical trial if SOC XOI therapy is considered medically not appropriate or contraindicated.
4. Subject must have been on SoC XOI therapy for gout and hyperuricemia for at least 4 weeks immediately before the Randomization Visit (Day 1, Visit 4) unless SoC XOI therapy is contraindicated or not medically appropriate. Subjects who stopped SoC XOI therapy within 4 weeks of the Screening Visit are eligible for the study but must be restarted on SoC XOI therapy and confirmed resistant to XOI therapy (sUA levels ≥7.0 mg/dL) after at least 4 weeks of treatment.
5. Subject must have 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).

Main Exclusion Criteria:

1. Subjects not previously diagnosed as having gout before the Screening Visit.
2. Female subject is pregnant, planning to get pregnant, lactating/breastfeeding, or has a positive urine pregnancy test at the Screening Visit or prior to randomization at the Randomization Visit (Day 1, Visit 4).
3. Subject has used any prescription drugs (eg, losartan, pegloticase, URAT1 inhibitors), OTC medications, herbal medications or products, vitamins, or minerals that are known to lower sUA levels (except SoC XOI therapies) within 14 days prior to the Randomization Visit (Day 1, Visit 4). Exceptions may be made on a case-by-case basis (such as chronic use of low dose aspirin) following discussion and agreement between the investigator and sponsor. Subjects who are already taking losartan for blood-pressure control are allowed to enroll in the study and continue taking losartan if they have been on a stable dose for at least 6 months.
4. Subject was not compliant with taking placebo during the Run-in Period (defined as taking <80% or >120% of planned placebo doses) or the investigator determines that the subject was not compliant with SoC XOI gout medications (unless SoC XOI therapy is contraindicated or not medically appropriate) during the Run-in Period as assessed prior to randomization at the Randomization Visit (Day 1, Visit 4).
5. Subject had an acute gout flare (exclusive of symptomology associated with chronic synovitis/arthritis) that did not resolve at least 14 days prior to the Randomization Visit (Day 1, Visit 4). If an acute gout flare occurs during the Screening or Run-in Periods, the subject may be rescreened after a period of at least 14 days has passed following resolution of the flare.
6. Serum creatinine level >1.5 mg/dL and/or eGFR ≤60 mL/min/1.73 m2 calculated using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation23 by central laboratory results at the Screening Visit (Visit 1) or prior to randomization at the Randomization Visit (Day 1, Visit 4).

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Carmen Arencibia; 9178067229; carmen.arencibia@shantonpharma.com

Contact: Shanshan Cui, PhD; 5138176839; shanshan.cui@shantonpharma.com

• Listed Location Countries: Puerto Rico, United States

Administrative Information

• NCT Number: NCT05690204
• Other Study ID Numbers: SAP001-202
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Shanton Pharma Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: Shanton Pharma Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Carmen Arencibia; Study Official

• PRS Account: Shanton Pharma Co., Ltd.
• Verification Date: August 2023