Trials / Completed
CompletedNCT05983445
Safety & Efffficacy of Genakumab in Patients With Frequent Flares
Safety & Efficacy of Genakumab in Patients With Frequent Flares
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 313 (actual)
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of Genakumab Injection in patients with Gouty Arthritis (GA).
Detailed description
A multicenter, randomized, double-blind, double-dummy, active-controlled study was to demonstrate the efficacy of Genakumab versus compound betamethasone injection in adult patients with frequent gouty arthritis attacks in whom non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine are contraindicated, are not tolerated, or do not provide an adequate response.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | genakumab | 200mg s.c. |
| DRUG | placebo for Diprospan | i.m. |
| DRUG | placebo for genakumab | s.c. |
| DRUG | Diprospan | 7mg i.m. |
Timeline
- Start date
- 2023-01-11
- Primary completion
- 2024-04-03
- Completion
- 2024-04-03
- First posted
- 2023-08-09
- Last updated
- 2024-12-18
Locations
1 site across 1 country: China
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05983445. Inclusion in this directory is not an endorsement.