A Study of IN026 in Participants With Refractory Gout (NCT07587684) | Clinical Trial Compass
Not Yet RecruitingPhase 1
A Study of IN026 in Participants With Refractory Gout
16 participantsStarted 2026-05
Plain-language summary
The goal of this clinical study is to learn if IN026 Injection is safe and works to lower uric acid levels in adults with refractory gout (gout that does not respond well to standard treatments). The main questions it aims to answer are:
* What medical problems do participants have when taking IN026, such as changes in vital signs, blood tests, or heart rhythm?
* How does the body absorb, process, and respond to IN026, and does it trigger an immune reaction?
* Does IN026 lower uric acid levels in the blood and reduce tophi?
Investigator will start with lower doses of IN026 and slowly increase the dose to find the well-tolerated dose.
Participants will:
* Receive IN026 through an intravenous (IV) drip into a vein at a set dose.
* Complete a screening period of up to 4 weeks, followed by treatment and check-ups for up to 20 weeks.
* Have blood and urine samples taken at set times to check safety and how the body responds to IN026.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.
. Male or female, 18-75 years old (inclusive) at screening.
. Meet 2015 ACR/EULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.
. Serum uric acid ≥420 μmol/L (7 mg/dl) at screening.
. Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)
Exclusion criteria
. Gout secondary to radiotherapy/chemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening/baseline.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Timeframe: From first dose (Week 1 Day 1) through end of study (Week 21)
Trial details
NCT IDNCT07587684
SponsorUnion Hospital, Tongji Medical College, Huazhong University of Science and Technology
Sponsor typeOTHER
Study typeINTERVENTIONAL
Primary completion2027-08
Contact for this trial
QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
. Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis at screening/baseline.
. Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.
. Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.
. Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.
. Participants with a history of any of the following: serious cardiovascular diseases within 6 months prior to screening; or serious diseases of the digestive, respiratory, urinary, musculoskeletal, neuropsychiatric, hematological, or immune systems within 3 months prior to screening.
. Prolonged QTcF at screening.
. Uncontrolled or untreated hypertension at screening.