Trials / Unknown
UnknownNCT06270225
A Study of SSGJ-613 in Gout Subjects Initiating Urate-Lowering Treatment.
A Randomized, Open-label, Active-Controlled Phase II Trial to Evaluate the Efficacy and Safety of SSGJ-613 for Prophylaxis Against Acute Gouty Arthritis Flares in Subjects Initiating Urate-Lowering Treatment.
- Status
- Unknown
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 157 (actual)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2024-03-30
- Primary completion
- 2024-10-01
- Completion
- 2024-12-01
- First posted
- 2024-02-21
- Last updated
- 2024-08-05
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06270225. Inclusion in this directory is not an endorsement.