Thinking of joining a study?

Register your interest

Become a volunteer?

NCT05665699 | RECRUITING | Gout

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

InventisBio Co., Ltd

Brief Summary:

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

Condition or disease

Gout

Intervention/treatment

D-0120

Allopurinol

Phase

PHASE2

Study Type : INTERVENTIONAL
Estimated Enrollment : 80 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : 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
Actual Study Start Date : 2023-04-17
Estimated Primary Completion Date : 2025-07-31
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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
Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout

Location Details

NCT05665699

Please Choose a site

How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Alabama

Study Center

Birmingham, Alabama, United States, 35233

RECRUITING

United States, California

Study Center

Panorama City, California, United States, 91402

RECRUITING

United States, Florida

Site Center

Plantation, Florida, United States, 33324

RECRUITING

United States, Illinois

Study Center

Evergreen Park, Illinois, United States, 60805

RECRUITING

United States, Indiana

Study Center

Brownsburg, Indiana, United States, 46254

NOT YET RECRUITING

United States, Kentucky

Site Center

Louisville, Kentucky, United States, 40205

RECRUITING

United States, North Carolina

Study Center

Hickory, North Carolina, United States, 28601

RECRUITING

United States, North Carolina

Study Center

Rocky Mount, North Carolina, United States, 27804

RECRUITING

United States, North Carolina

Study Center

Salisbury, North Carolina, United States, 28144

RECRUITING

United States, North Carolina

Study Center

Wilmington, North Carolina, United States, 28401

RECRUITING

United States, North Carolina

Study Center

Winston-Salem, North Carolina, United States, 27103

RECRUITING

United States, Pennsylvania

Study Center

Duncansville, Pennsylvania, United States, 16635

RECRUITING

United States, Pennsylvania

Study Center

Scottdale, Pennsylvania, United States, 15683

RECRUITING

United States, Tennessee

Study Center

Bristol, Tennessee, United States, 37620

NOT YET RECRUITING

United States, Tennessee

Site Center

Hendersonville, Tennessee, United States, 37075

RECRUITING

United States, Tennessee

Study Center

Knoxville, Tennessee, United States, 37909

RECRUITING

United States, Texas

Site Center

Fort Worth, Texas, United States, 76109

NOT YET RECRUITING

United States, Texas

Site Center

The Woodlands, Texas, United States, 77382

NOT YET RECRUITING

United States, Virginia

Site Center

Richmond, Virginia, United States, 23219

RECRUITING

United States, Washington

Site Center

Bellevue, Washington, United States, 98004

RECRUITING

United States, West Virginia

Study Center

Morgantown, West Virginia, United States, 26505