Trials / Unknown
UnknownNCT06169891
A Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
A Phase 3, Multicenter, Randomized, Double-blind, Double-dummy, Active-controlled Trial to Evaluate the Efficacy and Safety of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
- Status
- Unknown
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- 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-IL-1β humanized monoclonal antibody injection in Chinese participants with acute gout.
Detailed description
Study SSGJ-613-AG-III-01 is a phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled, parallel-group study examining the effect of recombinant anti-IL-1β humanized monoclonal antibody injection versus compound betamethasone injection in Chinese adult patients with frequent flares of acute gouty arthritis who are contraindicated, intolerant, or lack efficacy to non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine. The entire treatment period is 48 weeks, consisting of a double-blind treatment period of 24 weeks and an open treatment period of 24 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg | one s.c. injection of SSGJ-613 once, on Day 1. |
| OTHER | Placebo | Participants will receive Placebo matching Compound Betamethasone Injection to maintain the blinding of the Investigational Medicinal Products. |
| DRUG | Compound Betamethasone Injection | 1 mL i.m. once on Day 1 |
| OTHER | Placebo | Participants will receive Placebo matching SSGJ-613 to maintain the blinding of the Investigational Medicinal Products. |
Timeline
- Start date
- 2023-12-01
- Primary completion
- 2024-12-01
- Completion
- 2025-11-01
- First posted
- 2023-12-14
- Last updated
- 2023-12-14
Source: ClinicalTrials.gov record NCT06169891. Inclusion in this directory is not an endorsement.