IN026 for adults with refractory gout

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1, IV-dose–escalation study will evaluate the safety, pharmacokinetics, and preliminary efficacy of IN026 in adults with refractory gout. Participants receive IN026 via IV infusion across increasing dose levels, with up to 20 weeks of follow-up after a screening period. Researchers will monitor vital signs, lab tests, immune responses, and uric acid levels to see if the treatment lowers uric acid and tophi while identifying any dose-related safety issues. The trial aims to find a well-tolerated dose and gather initial signals about efficacy and tolerability.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Can voluntarily sign the informed consent form (ICF) and comply with ICF and study protocol requirements.
2. Male or female, 18-75 years old (inclusive) at screening.
3. Meet 2015 ACR/EULAR gout classification criteria, in the intercritical phase of gout or acute flare resolved ≥2 weeks at screening.
4. Serum uric acid ≥420 μmol/L (7 mg/dl) at screening.
5. Meet the definition of refractory gout (poor uric acid control accompanied by severe gout symptoms)

Exclusion Criteria:

1. Gout secondary to radiotherapy/chemotherapy, lead poisoning, organ transplantation, tumor, etc. at screening/baseline.
2. Rheumatoid arthritis, infectious/septic arthritis, or other acute inflammatory arthritis at screening/baseline.
3. Glucose-6-phosphate dehydrogenase (G6PD) deficiency history, or G6PD level below normal lower limit.
4. Positive HBsAg; HCV antibody positive is excluded except those with sustained HCV-RNA negativity after standard treatment; HIV antibody positive; active syphilis.
5. Presence of chronic liver diseases including active hepatitis, cirrhosis and alcoholic liver disease.
6. 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.
7. Prolonged QTcF at screening.
8. Uncontrolled or untreated hypertension at screening.
9. Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.
10. History of severe allergy, or known allergy to IN026 or its components.
11. Participation in other clinical trials within 30 days prior to screening.
12. Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.

Where it's running

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
  Wuhan, China Recruiting

Study contacts

• Principal investigator: QiuBai Li — Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
• Study coordinator: QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
• Email: qiubaili@hust.edu.cn
• Phone: +86-27-85726338

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.