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A Study of IN026 in Participants With Refractory Gout

A Clinical Study on the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics and Preliminary Efficacy of IN026 in the Treatment of Refractory Gout

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.

Studie Overzicht

Toestand

Werving

Interventie / Behandeling

Studietype

Ingrijpend

Inschrijving (Geschat)

16

Fase

  • Fase 1

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studiecontact

  • Naam: QiuBai Li Union Hospital, Tongji Medical College, Huazhong University of
  • Telefoonnummer: +86-27-85726338
  • E-mail: qiubaili@hust.edu.cn

Studie Locaties

      • Wuhan, China
        • Werving
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
          • Huazhong University of Science and Technology Union Hospital, Tongji Medical College,
          • Telefoonnummer: 027-85726685
          • E-mail: whuniongcp01@126.com

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

  • Volwassen
  • Oudere volwassene

Accepteert gezonde vrijwilligers

Nee

Beschrijving

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.

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: Niet-gerandomiseerd
  • Interventioneel model: Sequentiële toewijzing
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Experimenteel: IN026 at Dose-Level A
Participants receive intravenous IN026 Injection at dose-level A on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Experimenteel: IN026 at Dose-Level B
Participants receive intravenous IN026 Injection at dose-level B on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Experimenteel: IN026 at Dose-Level C
Participants receive intravenous IN026 Injection at dose-level C on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Experimenteel: IN026 at Dose-Level D
Participants receive intravenous IN026 Injection at dose-level D on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Experimenteel: IN026 at Dose-Level E
Participants receive intravenous IN026 Injection at dose-level E on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion
Experimenteel: IN026 at Dose-Level F
Participants receive intravenous IN026 Injection at dose-level F on Week 1 Day 1 (W1D1). Following safety/tolerability assessment, participants may receive extra doses (up to 5 in total) at predefined frequency.
IN026 Injection is a lipid nanoparticle (LNP)-formulated mRNA therapeutic administered as an intravenous (IV) infusion

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Incidence of Adverse Events (AEs), Treatment-Emergent Adverse Events (TEAEs), and Serious Adverse Events (SAEs)
Tijdsspanne: From first dose (Week 1 Day 1) through end of study (Week 21)
From first dose (Week 1 Day 1) through end of study (Week 21)

Secundaire uitkomstmaten

Uitkomstmaat
Tijdsspanne
Change from Baseline in Serum Uric Acid Concentration
Tijdsspanne: From baseline (Week 1 Day 1) through Week 21
From baseline (Week 1 Day 1) through Week 21
Change in Tophi from Baseline
Tijdsspanne: From baseline (Week 1 Day 1) through Week 21
From baseline (Week 1 Day 1) through Week 21
Plasma Concentration of IN026 mRNA Over Time
Tijdsspanne: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Plasma Concentration of Ionizable Lipid SX-66 Over Time
Tijdsspanne: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uricase Level Over Time
Tijdsspanne: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Uric Acid Level Over Time
Tijdsspanne: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Serum Allantoin Level Over Time
Tijdsspanne: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
Titer of Anti-Drug Antibodies (ADAs) Over Time
Tijdsspanne: At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21
At pre-specified timepoints from first dose (Week 1 Day 1) through Week 21

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Onderzoekers

  • Hoofdonderzoeker: QiuBai Li, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

12 juni 2026

Primaire voltooiing (Geschat)

1 augustus 2027

Studie voltooiing (Geschat)

1 mei 2028

Studieregistratiedata

Eerst ingediend

24 april 2026

Eerst ingediend dat voldeed aan de QC-criteria

7 mei 2026

Eerst geplaatst (Werkelijk)

14 mei 2026

Updates van studierecords

Laatste update geplaatst (Werkelijk)

31 juli 2026

Laatste update ingediend die voldeed aan QC-criteria

30 juli 2026

Laatst geverifieerd

1 juli 2026

Meer informatie

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

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