Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

A Randomized, Open-Label, Multiple-Dose Phase II Study to Evaluate Efficacy and Safety of D-0120 Administered in Combination With Allopurinol in Subjects With Gout

D-0120 is being tested in combination with Allopurinol in adult subjects with Gout.

Study Overview

• Status: Active, not recruiting
• Conditions: Gout
• Intervention / Treatment: Drug: D-0120; Drug: Allopurinol

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35233
      • Study Center
  • Florida
    • Plantation, Florida, United States, 33324
      • Site Center
  • Illinois
    • Evergreen Park, Illinois, United States, 60805
      • Study Center
  • Indiana
    • Brownsburg, Indiana, United States, 46254
      • Study Center
  • Kentucky
    • Louisville, Kentucky, United States, 40205
      • Site Center
  • North Carolina
    • Hickory, North Carolina, United States, 28601
      • Study Center
    • Rocky Mount, North Carolina, United States, 27804
      • Study Center
    • Salisbury, North Carolina, United States, 28144
      • Study Center
    • Wilmington, North Carolina, United States, 28401
      • Study Center
    • Winston-Salem, North Carolina, United States, 27103
      • Study Center
  • Pennsylvania
    • Scottdale, Pennsylvania, United States, 15683
      • Study Center
  • Tennessee
    • Bristol, Tennessee, United States, 37620
      • Study Center
    • Hendersonville, Tennessee, United States, 37075
      • Site Center
    • Knoxville, Tennessee, United States, 37909
      • Study Center
  • Texas
    • Fort Worth, Texas, United States, 76109
      • Site Center
    • The Woodlands, Texas, United States, 77382
      • Site Center
  • Virginia
    • Richmond, Virginia, United States, 23219
      • Site Center
  • Washington
    • Bellevue, Washington, United States, 98004
      • Site Center
  • West Virginia
    • Morgantown, West Virginia, United States, 26505
      • Study Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response
• Subject has had at least 2 gout flares in the previous 12 months.
• Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive).
• Male and Female Subjects must agree to abstain or use effective contraception methods from the time of signing ICF and for the duration of study participation through 30 days after the last dose of study drug.
• Subjects must have adequate clinical laboratory and ECG results as assessed by the Principal Investigator

Exclusion Criteria:

• Subjects with significant comorbidities, inadequate lab function, current (and within the past 5 years) diagnosis of cancer or any condition that, in the judgment of the investigator, would place him/her at undue risk, or potentially compromise the results or interpretation of the study.
• Women who are pregnant or breastfeeding

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cohort A; week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol	Drug: D-0120; increasing dose of D-0120; Drug: Allopurinol; standard dosing
Experimental: Cohort B; week 1: D-0120 low dose in combination with Allopurinol week 2: D-0120 increased dose in combination with Allopurinol week 3-12: D-0120 high dose in combination with Allopurinol	Drug: D-0120; increasing dose of D-0120; Drug: Allopurinol; standard dosing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
• To assess the efficacy of D-0120 in combination with allopurinol to reduce serum urate levels in treatment of patients with gout by week 12	12 weeks

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Study Director: Kathryn Stazzone, InventisBio Co., Ltd

Study record dates

Study Major Dates

• Study Start (Actual): April 17, 2023
• Primary Completion (Estimated): July 31, 2025
• Study Completion (Estimated): December 30, 2025

Study Registration Dates

• First Submitted: December 19, 2022
• First Submitted That Met QC Criteria: December 19, 2022
• First Posted (Actual): December 27, 2022

Study Record Updates

• Last Update Posted (Actual): May 8, 2025
• Last Update Submitted That Met QC Criteria: May 7, 2025
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Crystal Arthropathies; Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Metabolic Diseases; Gout; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Gout Suppressants; Antirheumatic Agents; Antimetabolites; Antioxidants; Protective Agents; Free Radical Scavengers; Allopurinol
• Other Study ID Numbers: D0120-205

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No