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Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

NCT07502105 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2026-04-20

No results posted yet for this study

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

  • Systemic Scleroderma

Interventions

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.

Sponsors & Collaborators

  • Tongji Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-05-01
Primary Completion
2027-04-01
Completion
2028-12-01

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07502105 on ClinicalTrials.gov