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

NCT06169891 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 500

Last updated 2023-12-14

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of recombinant anti-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.

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.

Sponsors & Collaborators

  • Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Hejian Zou, MD · Shanghai Huanshan Hospital Fudan University-Rheumatology

  • Qinghong Zhou, MD · Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-31
Primary Completion
2024-12-31
Completion
2025-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06169891 on ClinicalTrials.gov