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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion 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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05665699
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

InventisBio Co., Ltd
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Kathryn Stazzone
Principal Investigator Affiliation InventisBio Co., Ltd
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Gout
Arms & Interventions

Arms

Experimental: Cohort A

week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol

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

Interventions

Drug: - D-0120

increasing dose of D-0120

Drug: - Allopurinol

standard dosing

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Study Center, Birmingham, Alabama

Status

Recruiting

Address

Study Center

Birmingham, Alabama, 35233

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Panorama City, California

Status

Recruiting

Address

Study Center

Panorama City, California, 91402

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Evergreen Park, Illinois

Status

Recruiting

Address

Study Center

Evergreen Park, Illinois, 60805

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Brownsburg, Indiana

Status

Recruiting

Address

Study Center

Brownsburg, Indiana, 46254

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Charlotte, North Carolina

Status

Recruiting

Address

Study Center

Charlotte, North Carolina, 28209

Site Contact

Kathryn Stazzone

[email protected]

302-519-5966

Study Center, Hickory, North Carolina

Status

Recruiting

Address

Study Center

Hickory, North Carolina, 28601

Site Contact

Kathryn Stazzone

[email protected]

302-519-5966

Study Center, Rocky Mount, North Carolina

Status

Recruiting

Address

Study Center

Rocky Mount, North Carolina, 27804

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Salisbury, North Carolina

Status

Recruiting

Address

Study Center

Salisbury, North Carolina, 28144

Site Contact

Kathryn Stazzone

[email protected]

302-519-5966

Study Center, Wilmington, North Carolina

Status

Recruiting

Address

Study Center

Wilmington, North Carolina, 28401

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Winston-Salem, North Carolina

Status

Recruiting

Address

Study Center

Winston-Salem, North Carolina, 27103

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Duncansville, Pennsylvania

Status

Recruiting

Address

Study Center

Duncansville, Pennsylvania, 16635

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Scottdale, Pennsylvania

Status

Recruiting

Address

Study Center

Scottdale, Pennsylvania, 15683

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Bristol, Tennessee

Status

Recruiting

Address

Study Center

Bristol, Tennessee, 37620

Site Contact

Kathryn Stazzone

[email protected]

302-519-5966

Study Center, Knoxville, Tennessee

Status

Recruiting

Address

Study Center

Knoxville, Tennessee, 37909

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, San Antonio, Texas

Status

Recruiting

Address

Study Center

San Antonio, Texas, 78215

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966

Study Center, Morgantown, West Virginia

Status

Recruiting

Address

Study Center

Morgantown, West Virginia, 26505

Site Contact

Kathryn M Stazzone

[email protected]

302-519-5966