Phase II Study to Evaluate Efficacy and Safety of D-0120 in Combination With Allopurinol in Subjects With Gout
NCT ID: NCT05665699
Last Updated: 2025-05-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
ACTIVE_NOT_RECRUITING
PHASE2
80 participants
INTERVENTIONAL
2023-04-17
2025-12-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Evaluation of PK and Safety of D-0120 and Allopurinol
NCT05360628
Evaluate the Efficacy and Safety of D-0120 in Primary Hyperuricemia Patients
NCT05504083
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
NCT03291782
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
NCT02498652
D-0120 Safety and PK/PD Study in China
NCT03923868
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cohort A
week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
D-0120
increasing dose of D-0120
Allopurinol
standard dosing
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
D-0120
increasing dose of D-0120
Allopurinol
standard dosing
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
D-0120
increasing dose of D-0120
Allopurinol
standard dosing
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Women who are pregnant or breastfeeding
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
InventisBio Co., Ltd
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Kathryn Stazzone
Role: STUDY_DIRECTOR
InventisBio Co., Ltd
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Study Center
Birmingham, Alabama, United States
Site Center
Plantation, Florida, United States
Study Center
Evergreen Park, Illinois, United States
Study Center
Brownsburg, Indiana, United States
Site Center
Louisville, Kentucky, United States
Study Center
Hickory, North Carolina, United States
Study Center
Rocky Mount, North Carolina, United States
Study Center
Salisbury, North Carolina, United States
Study Center
Wilmington, North Carolina, United States
Study Center
Winston-Salem, North Carolina, United States
Study Center
Scottdale, Pennsylvania, United States
Study Center
Bristol, Tennessee, United States
Site Center
Hendersonville, Tennessee, United States
Study Center
Knoxville, Tennessee, United States
Site Center
Fort Worth, Texas, United States
Site Center
The Woodlands, Texas, United States
Site Center
Richmond, Virginia, United States
Site Center
Bellevue, Washington, United States
Study Center
Morgantown, West Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
D0120-205
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.