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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

157 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-30

Study Completion Date

2024-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Gout Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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SSGJ-613 100 mg

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

SSGJ-613 200 mg

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

Group Type EXPERIMENTAL

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

Intervention Type DRUG

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

Colchicine 0.5mg

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

Group Type ACTIVE_COMPARATOR

Colchicine 0.5 mg

Intervention Type DRUG

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

Interventions

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

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

Intervention Type DRUG

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

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

Intervention Type DRUG

Colchicine 0.5 mg

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

Intervention Type DRUG

Other Intervention Names

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SSGJ-613 100mg SSGJ-613 200mg

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No