Trials / Not Yet Recruiting
Not Yet RecruitingNCT07502105
Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
- Status
- Not Yet Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- Sponsor
- Tongji Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
This study is a single-center, single-arm, open-label, exploratory clinical trial. A total of 30 patients with diffuse cutaneous systemic sclerosis (dcSSc) will be enrolled. A historical control cohort will be established to evaluate the efficacy and safety of Firsekibart by comparing with historical data.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Firsekibart injection | Firsekibart, independently developed by GeneScience, was officially approved for marketing by the NMPA in July 2025 as China's first domestically developed fully human monoclonal antibody targeting IL-1β. |
Timeline
- Start date
- 2026-03-02
- Primary completion
- 2027-04-01
- Completion
- 2028-12-01
- First posted
- 2026-03-30
- Last updated
- 2026-03-30
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT07502105. Inclusion in this directory is not an endorsement.