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

NCT05690204 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: SAP-001-202
• Study Type: interventional
• Target: 87
• Locations: 2 countries
• Sites: 16

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.

Conditions

Gout

Keywords

Hyperuricemia; Serum Uric Acid; Gout Flare

Outcome Measures

Primary Outcomes (1)

• primary

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

  24 weeks

Secondary Outcomes (3)

• AE

  24 weeks

• Change from Baseline on PE measure

  24 weeks

• Changes from Baseline on ECGs

  24 weeks

Study Arms (4)

Placebo versus SAP-001

EXPERIMENTAL

Placebo arm

Drug: SAP-001

SAP-001 low dose

EXPERIMENTAL

SAP-001 low dose

Drug: SAP-001

SAP-001 middle dose

EXPERIMENTAL

SAP-001 middle dose

Drug: SAP-001

SAP-001 high dose

EXPERIMENTAL

SAP-001 high dose

Drug: SAP-001

Interventions

SAP-001 DRUG

Test the efficacy and safety of SAP-001 versus placebo

Also known as: Xanthine Oxidase Inhibitor, Colchicine

Placebo versus SAP-001; SAP-001 high dose; SAP-001 low dose; SAP-001 middle dose

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subjects not previously diagnosed as having gout before the Screening Visit.
• 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).
• 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.
• 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).
• 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.
• 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).

Sponsors & Collaborators

• Shanton Pharma Pte. Ltd.: lead

Study Sites (16)

California Site

Sacramento, California, 95821, United States

Location

California Site

San Diego, California, 92119, United States

Location

Denver Site

Denver, Colorado, 80230, United States

Location

Florida Site

DeBary, Florida, 32713, United States

Location

Florida Site

Miami, Florida, 33173, United States

Location

Florida Site

Miami Lakes, Florida, 33014, United States

Location

Florida Site

Miami Lakes, Florida, 33173, United States

Location

Florida Site

Winter Park, Florida, 32789, United States

Location

Idaho Site

Boise, Idaho, 83713, United States

Location

Maryland Site

Oxon Hill, Maryland, 20745, United States

Location

Mississippi Site

Jackson, Mississippi, 39202, United States

Location

North Carolina Site

Raleigh, North Carolina, 27612, United States

Location

Texas Site

Mesquite, Texas, 75150, United States

Location

Texas Site

Plano, Texas, 75093, United States

Location

Texas Site

The Woodlands, Texas, 77832, United States

Location

Puerto Rico Site

San Juan, 00907, Puerto Rico

Location

MeSH Terms

Conditions

Gout; Hyperuricemia

Interventions

Colchicine

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alkaloids; Heterocyclic Compounds

Study Officials

• Carmen Arencibia

  Study Official

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 12, 2022
• First Posted: January 19, 2023
• Study Start: December 12, 2022
• Primary Completion: January 1, 2025
• Study Completion: February 1, 2025
• Last Updated: November 14, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

PR (1); US (15)