A Study of IN026 in Participants With Refractory Gout
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: IN026 Injection.
- Who it may be relevant to
- Registry conditions: Refractory Gout. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout
Overview
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.
Interventions
- Drug IN026 Injection
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Primary outcome measures
- Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs) [Time frame: From first dose (Week 1 Day 1) through end of study (Week 21)]
Secondary outcome measures (8)
- Change from Baseline in Serum Uric Acid Concentration [Time frame: From baseline (Week 1 Day 1) through Week 21]
- Change in Tophi from Baseline [Time frame: From baseline (Week 1 Day 1) through Week 21]
- Plasma Concentration of IN026 mRNA Over Time [Time frame: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21]
- Plasma Concentration of Ionizable Lipid SX-66 Over Time [Time frame: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21]
- Serum Uricase Level Over Time [Time frame: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21]
- Serum Uric Acid Level Over Time [Time frame: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21]
- Serum Allantoin Level Over Time [Time frame: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21]
- Titer of Anti-Drug Antibodies (ADAs) Over Time [Time frame: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21]
Eligibility criteria
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.
- 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.
- Participants who have received medications that may affect endpoint assessment, such as other urate-lowering therapies, mRNA-LNP vaccine, PEGylated drugs and uricase agents.
- History of severe allergy, or known allergy to IN026 or its components.
- Participation in other clinical trials within 30 days prior to screening.
- Participants with poor compliance, or those deemed otherwise unsuitable for this study by the investigator.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology — Wuhan
Identifiers
NCT: NCT07587684 · IN026-001