Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
ConditionSystemic Scleroderma
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-70
SponsorTongji Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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;
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
Firsekibart injection
DrugFirsekibart, 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.
Treatment groups
30 Participants
are divided into 1 treatment groupGroup A: Firsekibart injectionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in the modified Rodnan Skin Score (mRSS) from baseline
The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51.
Time frame
Week 12Secondary outcomes
1
Change in modified Rodnan skin score (mRSS) from baseline
The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51.
Time frame
Week 16, 242
Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline
CRISS is a weighted score and includes five core set measures: modified Rodnan skin score, FVC% predicted, health assessment questionnaire-disability index, and patient and clinician global assessments.
Time frame
Week 12, 16, 243
Change from baseline in pulmonary function (FVC)
Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled after the deepest possible breath.
Time frame
Week 12, 16, 244
Change from baseline in pulmonary function (DLCO)
Diffusing capacity of the lungs for carbon monoxide (DLCO)is a key measure of gas diffusion across the alveolar-capillary membrane, determined by the single-breath method.
Time frame
Week 12, 16, 24Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: