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

Sunshine Guojian Pharmaceutical

Status and phase: Active, not recruiting; Phase 2

Conditions: Gout Arthritis

Treatments: Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg; Drug: Colchicine 0.5 mg; Drug: Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT06270225

SSGJ-613-PGF-II-01

Details and patient eligibility

About

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.

Enrollment: 157 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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157 participants in 3 patient groups

SSGJ-613 100 mg

Experimental group

Description:

Subjects will receive 100mg SSGJ-613 on Day 1.

Treatment:

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

SSGJ-613 200 mg

Experimental group

Description:

Subjects will receive 200mg SSGJ-613 on Day 1.

Treatment:

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

Colchicine 0.5mg

Active Comparator group

Description:

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

Treatment:

Drug: Colchicine 0.5 mg