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NCT05665699 Clinical Trial

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

Gout Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05665699
Other study ID # D0120-205
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 17, 2023
Est. completion date December 30, 2024

Study information
Verified date February 2024
Source InventisBio Co., Ltd
Contact Kathryn Stazzone
Phone 3025195966
Email kathryn.stazzone@inventisbio.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 80
Est. completion date December 30, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• D-0120
increasing dose of D-0120
• Allopurinol
standard dosing

Locations
Country Name City State
United States Study Center Birmingham Alabama
United States Study Center Bristol Tennessee
United States Study Center Brownsburg Indiana
United States Study Center Charlotte North Carolina
United States Study Center Duncansville Pennsylvania
United States Study Center Evergreen Park Illinois
United States Study Center Hickory North Carolina
United States Study Center Knoxville Tennessee
United States Study Center Morgantown West Virginia
United States Study Center Panorama City California
United States Study Center Rocky Mount North Carolina
United States Study Center Salisbury North Carolina
United States Study Center San Antonio Texas
United States Study Center Scottdale Pennsylvania
United States Study Center Wilmington North Carolina
United States Study Center Winston-Salem North Carolina

Sponsors (1)
Lead Sponsor Collaborator
InventisBio Co., Ltd

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary • 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
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