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

Phase 2

Active, not recruiting

• Conditions: Gout
• Interventions: Drug: D-0120; Drug: Allopurinol

• Registration Number: NCT05665699
• Lead Sponsor: InventisBio Co., Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-12-19
• Study First Submitted QC: 2022-12-19
• Study First Posted: 2022-12-27
• Study Start: 2023-04-17
• Status Verified: 2024-08
• Last Update Submitted: 2025-05-07
• Last Update Posted: 2025-05-08
• Primary Completion: 2025-07-31
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cohort A	D-0120	week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
Cohort A	Allopurinol	week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol
Cohort B	D-0120	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
Cohort B	Allopurinol	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

Primary Outcome Measures

Name	Time	Method
• 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

Trial Locations

Locations (2)

Study Center; 🇺🇸 Morgantown, West Virginia, United States

Site Center; 🇺🇸 Bellevue, Washington, United States