MedTrace Logo

A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.

NCT06270225 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 157

Last updated 2024-08-05

No results posted yet for this study

Summary

The purpose of this study is to determine the efficacy and safety of recombinant anti-interleukin-1β humanized monoclonal antibody injection in Chinese gout participants Initiating Urate-Lowering Treatment.

Conditions

  • Gout Arthritis

Interventions

DRUG

Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg

Subjects will receive one s.c. injection of SSGJ-613 on Day 1.

DRUG

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

Subjects will receive one s.c. injection of SSGJ-613 on Day 1.

DRUG

Colchicine 0.5 mg

Subjects will receive 0.5mg/d Colchicine for 12 weeks.

Sponsors & Collaborators

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

    lead INDUSTRY

Principal Investigators

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

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2024-03-30
Primary Completion
2024-10-31
Completion
2024-12-31

Countries

  • China

Study Locations

More Related Trials

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 NCT06270225 on ClinicalTrials.gov