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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05690204
Recruitment Status : Recruiting
First Posted : January 19, 2023
Last Update Posted : February 9, 2024
Sponsor:
Information provided by (Responsible Party):
Shanton Pharma Co., Ltd.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Gout Drug: SAP001 Phase 2

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : December 12, 2022
Estimated Primary Completion Date : December 30, 2024
Estimated Study Completion Date : January 30, 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Gout
MedlinePlus related topics: Gout

Arms and Interventions
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Arm Intervention/treatment
Experimental: Placebo versus SAP 001
Placebo arm
 Drug: SAP001
Test the efficacy and safety of SAP 001 versus placebo
Other Names:
  • Xanthine Oxidase Inhibitor
  • Colchicine
Experimental: SAP001 10 mg
SAP001 10 mg
 Drug: SAP001
Test the efficacy and safety of SAP 001 versus placebo
Other Names:
  • Xanthine Oxidase Inhibitor
  • Colchicine
Experimental: SAP001 30 mg
SAP001 30mg
 Drug: SAP001
Test the efficacy and safety of SAP 001 versus placebo
Other Names:
  • Xanthine Oxidase Inhibitor
  • Colchicine
Experimental: SAP001 60 mg
SAP001 60 mg
 Drug: SAP001
Test the efficacy and safety of SAP 001 versus placebo
Other Names:
  • Xanthine Oxidase Inhibitor
  • Colchicine


Outcome Measures
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Primary Outcome Measures :
  1. primary [ Time Frame: 24 weeks ]
    assess the proportion of subjects who achieved sUA levels less than 6 mg/dl by laboratory results


Secondary Outcome Measures :
  1. AE [ Time Frame: 24 weeks ]
    Incidence of AEs including SAE and TEAEs by CTCAE criteria

  2. Change from Baseline on PE measure [ Time Frame: 24 weeks ]
    Changes from baseline in Physical Exam based on number of participants with abnormal findings

  3. Changes from Baseline on ECGs [ Time Frame: 24 weeks ]
    Changes from baseline in ECG parameters by QTc intervals


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05690204


Contacts
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Contact: Carmen Arencibia 9178067229 carmen.arencibia@shantonpharma.com
Contact: Shanshan Cui, PhD 5138176839 shanshan.cui@shantonpharma.com

Locations
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United States, California
California Site Recruiting
Sacramento, California, United States, 95821
Contact: Leesa Koskela       leesa@ctrsites.com   
Principal Investigator: Jeffrey Wayne, MD         
California Site Recruiting
San Diego, California, United States, 92119
Contact: Timea Mathe       tmathe@triwestresearch.com   
Principal Investigator: Martin Kabongo, MD         
United States, Colorado
Denver Site Recruiting
Denver, Colorado, United States, 80230
Contact: Terri Herrud       therrud@dacdenver.com   
Principal Investigator: Christopher Antolini, MD         
United States, Florida
Florida Site Recruiting
DeBary, Florida, United States, 32713
Contact: Bridget Thompson       bthompson@omegarcllc.com   
Principal Investigator: Kwabena Ayesu, MD         
Florida Site Recruiting
Miami Lakes, Florida, United States, 33014
Contact: Yasnay Arias       yarias@pharmamedinnovations.com   
Principal Investigator: Alejandro Pla, MD         
Florida Site Recruiting
Miami Lakes, Florida, United States, 33173
Contact: Francis Santana       fsantana@panaxcr.com   
Principal Investigator: Robert Perry, MD         
Florida Site Recruiting
Miami, Florida, United States, 33173
Contact: Marice Obregon       mobregon@wpharma.com   
Principal Investigator: Eddie Armas, MD         
Florida Site Recruiting
Winter Park, Florida, United States, 32789
Contact: April Davis       April.Davis@conquestresearch.com;   
Principal Investigator: Anand Patel, MD         
United States, Idaho
Idaho Site Recruiting
Boise, Idaho, United States, 83713
Contact: Serena Strange       serena@familycareresearch.com   
Principal Investigator: Richard Randonovich, MD         
United States, Maryland
Maryland Site Recruiting
Oxon Hill, Maryland, United States, 20745
Contact: Spencer Ong       spencer.ong@mdmedicalresearch.com   
Principal Investigator: Stephen Ong, MD         
United States, Mississippi
Mississippi Site Recruiting
Jackson, Mississippi, United States, 39202
Contact: Candy Thomas       candycumberland@Hotmail.com   
Principal Investigator: Edwin Dodd, MD         
United States, North Carolina
North Carolina Site Recruiting
Raleigh, North Carolina, United States, 27612
Contact: Christian Newton       cnewton@wakeresearch.com   
Principal Investigator: Lisa Cohen, MD         
United States, Texas
Texas Site Recruiting
Mesquite, Texas, United States, 75150
Contact: Chudi Nwoye       cnwoye@swrr.net   
Principal Investigator: Atul Singal, MD         
Texas Site Recruiting
Plano, Texas, United States, 75093
Contact: Dat Tran       dat.tran@aimtrials.com   
Principal Investigator: Saumil Mehta, MD         
Texas Site Recruiting
The Woodlands, Texas, United States, 77832
Contact: David Ekunno       davide@advancedrheum.com   
Principal Investigator: Tamar Brionez, MD         
Puerto Rico
Puerto Rico Site Recruiting
San Juan, Puerto Rico, 00907
Contact: Edward Morales       moralese@brcrglobal.com   
Principal Investigator: Jose Rodriguez, MD         
Sponsors and Collaborators
Shanton Pharma Co., Ltd.
Investigators
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Study Director: Carmen Arencibia Study Official
More Information
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Responsible Party: Shanton Pharma Co., Ltd.
ClinicalTrials.gov Identifier: NCT05690204    
Other Study ID Numbers: SAP001-202
First Posted: January 19, 2023    Key Record Dates
Last Update Posted: February 9, 2024
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Shanton Pharma Co., Ltd.:
Hyperuricemia
Serum Uric Acid
Gout Flare
Additional relevant MeSH terms:
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Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
 Metabolic Diseases
Colchicine
Gout Suppressants
Antirheumatic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents