NCT05665699

Brief Summary

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

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2023

Geographic Reach
1 country

19 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 19, 2022

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 27, 2022

Completed
4 months until next milestone

Study Start

First participant enrolled

April 17, 2023

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2025

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2025

Completed
Last Updated

May 8, 2025

Status Verified

August 1, 2024

Enrollment Period

2.3 years

First QC Date

December 19, 2022

Last Update Submit

May 7, 2025

Conditions

Gout

Outcome Measures

Primary Outcomes (1)

  • • 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

Study Arms (2)

Cohort A

EXPERIMENTAL

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

Drug: D-0120Drug: Allopurinol

Cohort B

EXPERIMENTAL

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-0120Drug: Allopurinol

Interventions

D-0120DRUG

increasing dose of D-0120

Cohort ACohort B
AllopurinolDRUG

standard dosing

Cohort ACohort B

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (19)

Study Center

Birmingham, Alabama, 35233, United States

Location

Site Center

Plantation, Florida, 33324, United States

Location

Study Center

Evergreen Park, Illinois, 60805, United States

Location

Study Center

Brownsburg, Indiana, 46254, United States

Location

Site Center

Louisville, Kentucky, 40205, United States

Location

Study Center

Hickory, North Carolina, 28601, United States

Location

Study Center

Rocky Mount, North Carolina, 27804, United States

Location

Study Center

Salisbury, North Carolina, 28144, United States

Location

Study Center

Wilmington, North Carolina, 28401, United States

Location

Study Center

Winston-Salem, North Carolina, 27103, United States

Location

Study Center

Scottdale, Pennsylvania, 15683, United States

Location

Study Center

Bristol, Tennessee, 37620, United States

Location

Site Center

Hendersonville, Tennessee, 37075, United States

Location

Study Center

Knoxville, Tennessee, 37909, United States

Location

Site Center

Fort Worth, Texas, 76109, United States

Location

Site Center

The Woodlands, Texas, 77382, United States

Location

Site Center

Richmond, Virginia, 23219, United States

Location

Site Center

Bellevue, Washington, 98004, United States

Location

Study Center

Morgantown, West Virginia, 26505, United States

Location

MeSH Terms

Conditions

Gout

Interventions

Allopurinol

Condition Hierarchy (Ancestors)

ArthritisJoint DiseasesMusculoskeletal DiseasesCrystal ArthropathiesRheumatic DiseasesPurine-Pyrimidine Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

PurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Kathryn Stazzone

    InventisBio Co., Ltd

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Randomized , Open Label, Multiple Dose
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2022

First Posted

December 27, 2022

Study Start

April 17, 2023

Primary Completion

July 31, 2025

Study Completion

December 30, 2025

Last Updated

May 8, 2025

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(19)