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

InventisBio

Status and phase: Enrolling; Phase 2

Conditions: Gout

Treatments: Drug: Allopurinol; Drug: D-0120

Study type: Interventional

Funder types: Industry

Identifiers

NCT05665699

D0120-205

Details and patient eligibility

About

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

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Cohort A

Experimental group

Description:

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

Treatment:

Drug: D-0120

Drug: Allopurinol

Cohort B

Experimental group

Description:

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

Treatment:

Drug: D-0120

Drug: Allopurinol