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New drug combo aims to tame stubborn gout flares

NCT ID NCT05665699

Disease control Sponsor: InventisBio Co., Ltd Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 09, 2026 · Last updated Jul 10, 2026 · Updated 1 time

Summary

This study tests whether adding an investigational drug called D-0120 to the standard gout medication allopurinol can lower uric acid levels more effectively than allopurinol alone. The trial enrolls adults with gout who have had at least two flares in the past year and whose uric acid is not well controlled with current treatment. Participants receive D-0120 plus allopurinol for 12 weeks, and researchers measure changes in uric acid levels and safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
D-0120 (an investigational drug) combined with allopurinol
What this could lead to
If successful, this combination could offer a more effective way to lower uric acid and reduce painful gout flares for people who don't respond well to standard therapy.
What could go wrong
This is an early-phase (phase II) trial with only 80 participants, so results may not apply to everyone. The drug combination may cause side effects or fail to show meaningful benefit over existing treatments.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

80 people

The number who actually took part.

Started

Apr 2023

Finished

Dec 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

gout

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Gout

Contacts and locations

Locations

  • Site Center

    Plantation, Florida, 33324, United States

  • Site Center

    Louisville, Kentucky, 40205, United States

  • Site Center

    Hendersonville, Tennessee, 37075, United States

  • Site Center

    Fort Worth, Texas, 76109, United States

  • Site Center

    The Woodlands, Texas, 77382, United States

  • Site Center

    Richmond, Virginia, 23219, United States

  • Site Center

    Bellevue, Washington, 98004, United States

  • Study Center

    Birmingham, Alabama, 35233, United States

  • Study Center

    Evergreen Park, Illinois, 60805, United States

  • Study Center

    Brownsburg, Indiana, 46254, United States

  • Study Center

    Hickory, North Carolina, 28601, United States

  • Study Center

    Rocky Mount, North Carolina, 27804, United States

  • Study Center

    Salisbury, North Carolina, 28144, United States

  • Study Center

    Wilmington, North Carolina, 28401, United States

  • Study Center

    Winston-Salem, North Carolina, 27103, United States

  • Study Center

    Scottdale, Pennsylvania, 15683, United States

  • Study Center

    Bristol, Tennessee, 37620, United States

  • Study Center

    Knoxville, Tennessee, 37909, United States

  • Study Center

    Morgantown, West Virginia, 26505, United States

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