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Anti-gout agent
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
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
Completed Phase 4
~6150
Find a Location
Who is running the clinical trial?
InventisBio Co., LtdLead Sponsor
19 Previous Clinical Trials
1,758 Total Patients Enrolled
1 Trials studying Gout
39 Patients Enrolled for Gout
Kathryn StazzoneStudy DirectorInventisBio Co., Ltd
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I agree to use effective birth control during and for 30 days after the study.I am not pregnant or breastfeeding.I have gout and my current treatment isn't lowering my uric acid levels enough.I have experienced at least 2 gout attacks in the last year.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort B
- Group 2: Cohort A
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.