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Not yet recruiting NCT07502105

Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

No phase Interventional Systemic Scleroderma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Firsekibart injection.
Who it may be relevant to
Registry conditions: Systemic Scleroderma. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

Overview

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.

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.

Primary outcome measures

  • Change in the modified Rodnan Skin Score (mRSS) from baseline [Time frame: Week 12]
Secondary outcome measures (6)
  • Change in modified Rodnan skin score (mRSS) from baseline [Time frame: Week 16, 24]
  • Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline [Time frame: Week 12, 16, 24]
  • Change from baseline in pulmonary function (FVC) [Time frame: Week 12, 16, 24]
  • Change from baseline in pulmonary function (DLCO) [Time frame: Week 12, 16, 24]
  • Change in serum IL-1β levels from baseline [Time frame: Week 12, 16, 24]
  • Change in serum IL-6 levels from baseline [Time frame: Week 12, 16, 24]

Eligibility criteria

Inclusion criteria

  • Age 18-70 years (inclusive), male or female.
  • Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR diagnostic criteria.
  • Disease duration of diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy \& Medsger (2001), of ≤ 5 years (from the time of first onset of non-Raynaud's phenomenon).
  • Modified Rodnan skin score (mRSS) ≥10;
  • Voluntarily signed informed consent form and ability to comply with the requirements of the study protocol.

Exclusion criteria

  • Allergy to the active ingredient of Firsekibart or any of its excipients, or a history of allergy to monoclonal antibodies.
  • Presence of any rheumatic disease other than SSc.
  • Moderate to severe lung disease with FVC < 60% or DLCO < 50% of predicted value.
  • Use of medications that may interfere with the evaluation of the efficacy and safety of Firsekibart, except for stable use of permitted concomitant therapies that have been maintained for at least 4 weeks prior to screening and are kept at a stable dose throughout the study period.
  • Use of biological agents or stem cell therapy within 3 months prior to screening or within 5 half-lives of the known drug.
  • Receipt of live or attenuated vaccines within two months prior to screening.
  • Severe hepatic impairment, renal impairment, or hematologic abnormalities at screening.
  • Acute or chronic infection (excluding infection complicated by finger ulceration), active infection, history of malignant tumor, or immunodeficiency disorder.
  • Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.
  • Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

China · 1 center
  • Tongji Hospital, Tong ji Medical Colledge — Wuhan

Identifiers

NCT: NCT07502105 · TJ-IRB202601060

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗