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

Phase 2

Active, not recruiting

• Conditions: Gout Arthritis
• Interventions: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg; Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg; Drug: Colchicine 0.5 mg

• Registration Number: NCT06270225
• Lead Sponsor: Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-02
• Study First Submitted: 2024-02-05
• Study First Submitted QC: 2024-02-19
• Study First Posted: 2024-02-21
• Study Start: 2024-03-30
• Last Update Submitted: 2024-08-01
• Last Update Posted: 2024-08-05
• Primary Completion: 2024-10
• Study Completion: 2024-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 157

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SSGJ-613 100 mg	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg	Subjects will receive 100mg SSGJ-613 on Day 1.
SSGJ-613 200 mg	Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg	Subjects will receive 200mg SSGJ-613 on Day 1.
Colchicine 0.5mg	Colchicine 0.5 mg	Subjects will receive 0.5mg/d Colchicine for 12 weeks.

Primary Outcome Measures

Name	Time	Method
Numbers of acute gout flares	12 weeks

Secondary Outcome Measures

Name	Time	Method
Numbers of acute gout flares	24 weeks
Duration of acute gout flares.	24 weeks
Subject's overall assessment of response to treatment	24 weeks	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.
Proportions of subjects with at least 1 acute gout flare	24 weeks
Investigator's overall assessment of response to treatment	24 weeks	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.
Adverse events (AE)	24 weeks
Time from randomization to first acute flare.	24 weeks
36-item Short Form Survey (SF-36)	24 weeks	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.

Trial Locations

Locations (1)

Shanghai Huashan Hospital Fudan University-Rheumatology; 🇨🇳 Shanghai, Shanghai, China