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

Phase 2Active Not RecruitingNCT06270225

Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.157 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

157

Conditions

Gout Arthritis

Interventions

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

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

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

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

Colchicine 0.5 mgDRUG

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Must be 18 Years to 75 Years, both male and female. * BMI ≤40 kg/m2. * Meeting the American College of Rheumatology (ACR) 2015 criteria for the classification of gouty arthritis. * ≥2 acute gout flares within 1 year prior to screening. * Willingness to initiate urate-lowering treatment or to initiate urate-lowering treatment within 7 days prior to administration. Exclusion Criteria: * Gout caused by radiotherapy/chemotherapy, organ transplantation, tumors, etc. * Evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis. * Presence of severe renal function impairment. * Intolerance of subcutaneous injection. * Known presence or suspicion of active or recurrent bacterial, fungal, or viral infection at the time of enrollment. * Live vaccinations within 8 weeks prior to the start of the study. * Use of forbidden therapy

Locations (1)

Shanghai Huashan Hospital Fudan University-Rheumatology

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

Numbers of acute gout flares

Time frame: 12 weeks

Secondary Outcomes

Numbers of acute gout flares

Time frame: 24 weeks

Proportions of subjects with at least 1 acute gout flare

Time frame: 12 weeks

Proportions of subjects with at least 1 acute gout flare

Time frame: 24 weeks

Time from randomization to first acute flare.

Time frame: 24 weeks

Duration of acute gout flares.

Time frame: 12 weeks

Duration of acute gout flares.

Time frame: 24 weeks

Subject's overall assessment of response to treatment

Response to treatment will be assessed by the subjects using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor.

Time frame: 24 weeks

Investigator's overall assessment of response to treatment

Response to treatment will be assessed by the Investigators using a five-point Likert scale: 1-very good, 2-good, 3-fair, 4-poor, and 5-very poor.

Time frame: 24 weeks

36-item Short Form Survey (SF-36)

36-Item Short Form Survey (SF-36) will be used to assess the health and functional changes of the subjects. It comprises 36 items that measure perceived health on eight scales (i.e., physical functioning, physical role, bodily pain, general health, vitality, social functioning, emotional role, and mental health) with higher scores (range 0-100) reflecting better perceived health.

Data from ClinicalTrials.gov

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