Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis (NCT07502105) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
China30 participantsStarted 2026-05-01
Plain-language 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.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in the modified Rodnan Skin Score (mRSS) from baseline
. 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.