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

• Sponsor: InventisBio Co., Ltd (Industry)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05665699
• Collaborator: (none)
• Enrollment: 80
• Arms: 2
• Anticipated Duration (Months): 14.1

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Gout	Drug: D-0120; Drug: Allopurinol	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Randomized , Open Label, Multiple DoseRandomized , Open Label, Multiple Dose
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Anticipated Study Start Date: Feb 27, 2023
• Anticipated Primary Completion Date: Jan 23, 2024
• Anticipated Study Completion Date: Apr 30, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cohort A week 1: D-0120 low dose in combination with Allopurinol week 2-12: D-0120 increased dose in combination with Allopurinol	Drug: D-0120; increasing dose of D-0120; Drug: Allopurinol; standard dosing
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	Drug: D-0120; increasing dose of D-0120; Drug: Allopurinol; standard dosing

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Gout subjects meeting 2015 ACR/EULAR Gout Classification Criteria with inadequate urate-lowering response

• Subject has reported at least 2 gout flares in the previous 12 months.

• Body Mass Index (BMI) between 18.0 and 40.0 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• InventisBio Co., Ltd

Investigators

• Study Director: Kathryn Stazzone, InventisBio Co., Ltd

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: InventisBio Co., Ltd
• ClinicalTrials.gov Identifier: NCT05665699
• Other Study ID Numbers: D0120-205
• First Posted: Dec 27, 2022
• Last Update Posted: Jan 9, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Gout; Allopurinol

Study Results

No Results Posted as of Jan 9, 2023