NCT05800041

A Exploratory Trial of WTX221 in Refractory Gout Patients

A Exploratory Trial to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD), Immunogenicity, and Preliminary Efficacy of WTX221 Infusion in Patients With Refractory Gout

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 7 (estimated)
• Sponsor: RenJi Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Refractory gout is usually associated with persistently swollen and tender joints, chronic pain, reduced functional status, impaired quality of life, and joint destruction，most of the patients can't tolerate urate-lowering therapy(ULT)or receive adequate dose of ULT treatment recommended to control Serum uric acid (SUA) to target level. WTX221 is designed to induce antigen-specific immune tolerance. WTX221 is made of urate oxidase(UOX) molecules conjugated on the surface of Red blood cells(RBCs), which can induce antigen-specific immune tolerance to UOX in vivo by making use of it's natural biologic characteristics. WTX221 infusion combined with a single dose 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.

Conditions

• Gout Tophus

Interventions

Type	Name	Description
DRUG	WTX221	Drug: WTX221 WTX221 infusion once every 30 days for two doses in total Drug: CTX Co-administration of CTX and WTX221 at the initial infusion

Timeline

• Start date: 2023-04-10
• Primary completion: 2023-07-30
• Completion: 2024-02-01
• First posted: 2023-04-05
• Last updated: 2023-04-05