NCT06169891View on ClinicalTrials.gov

A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout

PHASE3Not yet recruitingINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

December 31, 2023

Primary Completion Date

December 31, 2024

Study Completion Date

November 30, 2025

Conditions
Acute Gout
Interventions
DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg

one s.c. injection of SSGJ-613 once, on Day 1.

OTHER

Placebo

Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products.

DRUG

Compound Betamethasone Injection

1 mL i.m. once on Day 1

OTHER

Placebo

Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products.

All Listed Sponsors
lead

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

INDUSTRY