D-0120 + Allopurinol for Gout

Phase 2

Recruiting

Research Sponsored by InventisBio Co., Ltd

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new drug, D-0120, with an existing one (Allopurinol) to treat Gout in adults.

Who is the study for?

Adults with gout who've had at least 2 flares in the past year can join this trial. They need to have a BMI between 18 and 40, respond poorly to urate-lowering treatments, and pass certain lab tests. Participants must not be pregnant or breastfeeding, have serious other illnesses, recent cancer history, or any condition that could risk their safety or affect study results.

What is being tested?

The trial is testing D-0120 combined with Allopurinol for gout treatment. It's a Phase II study which means they're looking at how well it works and checking its safety in people who meet specific health criteria.

What are the potential side effects?

While the side effects of D-0120 are not detailed here, common side effects from similar medications may include stomach issues, rash, fatigue. Allopurinol can cause skin reactions, gastrointestinal discomfort and rarely more severe conditions.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Cohort BExperimental Treatment2 Interventions

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

Group II: Cohort AExperimental Treatment2 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

D-0120

2019

Completed Phase 2

~260

Allopurinol

1999