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
Qualifiers
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
Treatments tested in this trial
- Firsekibart injection
Treatment groups
30 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov