80 Participants Needed

D-0120 + Allopurinol for Gout

Recruiting at 23 trial locations
KS
Overseen ByKathryn Stazzone
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: InventisBio Co., Ltd
Must be taking: Allopurinol
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since the trial involves testing a new drug with Allopurinol, it's best to discuss your current medications with the study team.

What data supports the effectiveness of the drug Allopurinol for treating gout?

Allopurinol is considered one of the most effective drugs for lowering uric acid levels in chronic gout, and it is frequently used for this purpose. It is a xanthine oxidase inhibitor, which helps prevent gout attacks by reducing uric acid production.12345

Is the combination of D-0120 and Allopurinol safe for humans?

Allopurinol is generally safe for most people, but some may experience serious allergic reactions, which are rare but can be severe. These reactions can include skin rashes, fever, and kidney problems, and certain genetic factors may increase the risk.46789

What makes the drug D-0120 + Allopurinol unique for treating gout?

The combination of D-0120 and Allopurinol for treating gout is unique because it potentially offers a novel approach by combining two agents, which may enhance the uric acid-lowering effects compared to Allopurinol alone. This could be particularly beneficial for patients who do not respond adequately to standard Allopurinol treatment.1241011

Research Team

KS

Kathryn Stazzone

Principal Investigator

InventisBio Co., Ltd

Eligibility Criteria

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.

Inclusion Criteria

I agree to use effective birth control during and for 30 days after the study.
I have gout and my current treatment isn't lowering my uric acid levels enough.
Body Mass Index (BMI) between 18.0 and 45.0 kg/m2 (inclusive)
See 2 more

Exclusion Criteria

I am not pregnant or breastfeeding.
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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive D-0120 in combination with Allopurinol. Cohort A: week 1 low dose, weeks 2-12 increased dose. Cohort B: week 1 low dose, week 2 increased dose, weeks 3-12 high dose.

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Allopurinol
  • D-0120
Trial Overview 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.
Participant Groups
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

Allopurinol is already approved in United States, European Union, Canada, Japan for the following indications:

🇺🇸
Approved in United States as Zyloprim for:
  • Gout
  • Kidney stones
  • High uric acid levels after chemotherapy
🇪🇺
Approved in European Union as Zyloric for:
  • Gout
  • Kidney stones
  • High uric acid levels after chemotherapy
🇨🇦
Approved in Canada as Allopurinol for:
  • Gout
  • Kidney stones
  • High uric acid levels after chemotherapy
🇯🇵
Approved in Japan as Allopurinol for:
  • Gout
  • Kidney stones
  • High uric acid levels after chemotherapy

Find a Clinic Near You

Who Is Running the Clinical Trial?

InventisBio Co., Ltd

Lead Sponsor

Trials
20
Recruited
1,800+

Findings from Research

For patients allergic to allopurinol, alternative treatments for hyperuricemia include uricosuric drugs like probenecid and sulfinpyrazone, but these are only suitable for those with normal kidney function and no history of kidney stones.
In cases where traditional treatments are ineffective or not tolerated, options like slow oral desensitization to allopurinol or the use of oxipurinol can be beneficial, especially for patients who have not responded to other therapies.
Difficult gout and new approaches for control of hyperuricemia in the allopurinol-allergic patient.Fam, AG.[2022]
The management of gout involves three key stages: treating acute attacks, lowering uric acid levels to prevent future flares, and providing prophylaxis against acute attacks, with NSAIDs being the preferred treatment for acute inflammation if started early.
For chronic gout management, xanthine oxidase inhibitors like allopurinol are recommended as first-line treatments, especially for patients with renal issues or those on diuretics, while uricosuric drugs are suitable for patients allergic to allopurinol.
Management of acute and chronic gouty arthritis: present state-of-the-art.Schlesinger, N.[2018]
A systematic review and meta-analysis of four studies found no significant association between allopurinol use and all-cause mortality in patients with gout, suggesting it is safe in this regard (adjusted HR 0.80).
While two studies indicated that allopurinol may have a protective effect against mortality, the overall evidence is limited, highlighting the need for further research to clarify its long-term effects.
Mortality in Patients With Gout Treated With Allopurinol: A Systematic Review and Meta-Analysis.Hay, CA., Prior, JA., Belcher, J., et al.[2022]

References

Difficult gout and new approaches for control of hyperuricemia in the allopurinol-allergic patient. [2022]
Management of acute and chronic gouty arthritis: present state-of-the-art. [2018]
Mortality in Patients With Gout Treated With Allopurinol: A Systematic Review and Meta-Analysis. [2022]
Lack of efficacy during the switch from brand to generic allopurinol. [2013]
Allopurinol for chronic gout. [2023]
Safety and efficacy of febuxostat treatment in subjects with gout and severe allopurinol adverse reactions. [2015]
Allopurinol hypersensitivity: a systematic review of all published cases, 1950-2012. [2022]
Allopurinol hypersensitivity: investigating the cause and minimizing the risk. [2022]
Allopurinol Use and Risk of Fatal Hypersensitivity Reactions: A Nationwide Population-Based Study in Taiwan. [2016]
10.United Statespubmed.ncbi.nlm.nih.gov
Pharmacokinetics and comparative bioavailability of allopurinol formulations in healthy subjects. [2018]
The effect of benzbromarone on allopurinol/oxypurinol kinetics in patients with gout. [2022]