drugset / Trial / NCT05800041
A Exploratory Trial of WTX221 in Refractory Gout Patients
Non-randomizedSingle-groupOpen-labelTreatment
Summary
This trial is a single-center, open-label designed investigator-initiated clinical study (IIT) to investigate the safety, tolerability, PK, PD, immunogenicity, and preliminary efficacy of multiple doses of WTX221 infusion combined with a single dose of the immunosuppressive agent cyclophosphamide (CTX) to induce immune tolerance. The trial consisted of a Screening Period (14 days), a First Dose Period (30 days), a Second Dose Period (30 days), and a Safety Follow-up Period (150 days) for a total of 224 days.
Timeline
- Start
- 2023-04-10
- Primary completion
- 2023-07-30
- Completion
- 2024-02-01
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Background | Cyclophosphamide | Other / unclassified | — | Other |
| Background | Cyclophosphamide | Other / unclassified | — | — |