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

Last updated: May 7, 2025
Sponsor: InventisBio Co., Ltd
Overall Status: Active - Not Recruiting

Phase

2

Condition

Musculoskeletal Diseases

Arthritis And Arthritic Pain (Pediatric)

Bone Diseases

Treatment

D-0120

Allopurinol

Clinical Study ID

NCT05665699
D0120-205
  • Ages 18-75
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequateurate-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 contraceptionmethods from the time of signing ICF and for the duration of study participationthrough 30 days after the last dose of study drug.

  • Subjects must have adequate clinical laboratory and ECG results as assessed by thePrincipal Investigator

Exclusion

Exclusion Criteria:

  • Subjects with significant comorbidities, inadequate lab function, current (andwithin the past 5 years) diagnosis of cancer or any condition that, in the judgmentof the investigator, would place him/her at undue risk, or potentially compromisethe results or interpretation of the study.

  • Women who are pregnant or breastfeeding

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: D-0120
Phase: 2
Study Start date:
April 17, 2023
Estimated Completion Date:
December 30, 2025

Connect with a study center

  • Study Center

    Birmingham, Alabama 35233
    United States

    Site Not Available

  • Study Center

    Panorama City, California 91402
    United States

    Site Not Available

  • Site Center

    Plantation, Florida 33324
    United States

    Site Not Available

  • Study Center

    Evergreen Park, Illinois 60805
    United States

    Site Not Available

  • Study Center

    Brownsburg, Indiana 46254
    United States

    Site Not Available

  • Site Center

    Louisville, Kentucky 40205
    United States

    Site Not Available

  • Study Center

    Charlotte, North Carolina 28209
    United States

    Site Not Available

  • Study Center

    Hickory, North Carolina 28601
    United States

    Site Not Available

  • Study Center

    Rocky Mount, North Carolina 27804
    United States

    Site Not Available

  • Study Center

    Salisbury, North Carolina 28144
    United States

    Site Not Available

  • Study Center

    Wilmington, North Carolina 28401
    United States

    Site Not Available

  • Study Center

    Winston-Salem, North Carolina 27103
    United States

    Site Not Available

  • Study Center

    Duncansville, Pennsylvania 16635
    United States

    Site Not Available

  • Study Center

    Scottdale, Pennsylvania 15683
    United States

    Site Not Available

  • Study Center

    Bristol, Tennessee 37620
    United States

    Site Not Available

  • Site Center

    Hendersonville, Tennessee 37075
    United States

    Site Not Available

  • Study Center

    Knoxville, Tennessee 37909
    United States

    Site Not Available

  • Dallas

    Dallas, Texas 75154
    United States

    Site Not Available

  • Site Center

    Fort Worth, Texas 76109
    United States

    Site Not Available

  • Study Center

    San Antonio, Texas 78215
    United States

    Site Not Available

  • Site Center

    The Woodlands, Texas 77382
    United States

    Site Not Available

  • Site Center

    Richmond, Virginia 23219
    United States

    Site Not Available

  • Site Center

    Bellevue, Washington 98004
    United States

    Site Not Available

  • Study Center

    Morgantown, West Virginia 26505
    United States

    Site Not Available

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