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Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis 30 Open-Label

Not yet recruiting
Clinical Trial NCT07502105 is an interventional study for Systemic Scleroderma and is currently not yet recruiting. Enrollment is planned to begin on 2 March 2026 and continue until the study accrues 30 participants. Led by Tongji Hospital, this study is expected to complete by 1 December 2028. The latest data from ClinicalTrials.gov was last updated on 30 March 2026.
Brief 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.
Official Title

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

Conditions
Systemic Scleroderma
Other Study IDs
  • TJ-IRB202601060
NCT ID Number
NCT07502105
Start Date (Actual)
2026-03-02
Last Update Posted
2026-03-30
Completion Date (Estimated)
2028-12-01
Enrollment (Estimated)
30
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Systemic Scleroderma
SSc
Primary Purpose
Treatment
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
Participant Group/ArmIntervention/Treatment
ExperimentalFirsekibart injection
Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8.
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
Outcome MeasureMeasure DescriptionTime Frame
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.
Week 12
Secondary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
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.
Week 16, 24
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.
Week 12, 16, 24
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.
Week 12, 16, 24
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.
Week 12, 16, 24
Change in serum IL-1β levels from baseline
IL-1β plays an important role in inflammation and fibrosis, and its expression is aberrantly regulated in various autoimmune diseases. IL-1β is considered an effective target for diseases associated with fibrosis and tissue remodeling.
Week 12, 16, 24
Change in serum IL-6 levels from baseline
IL-1β acts as a potent upstream stimulus for IL-6 production. IL-6 activates fibroblasts, promoting their proliferation and driving the abundant synthesis of collagen and extracellular matrix components. In parallel, IL-6 induces endothelial-to-mesenchymal transition in endothelial cells, thereby exacerbating the vicious cycle between microvascular pathology and fibrosis.
Week 12, 16, 24
Participation Assistant
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  1. Age 18-70 years (inclusive), male or female.
  2. Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR diagnostic criteria.
  3. 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).
  4. Modified Rodnan skin score (mRSS) ≥10;
  5. Voluntarily signed informed consent form and ability to comply with the requirements of the study protocol.

  1. Allergy to the active ingredient of Firsekibart or any of its excipients, or a history of allergy to monoclonal antibodies.
  2. Presence of any rheumatic disease other than SSc.
  3. Moderate to severe lung disease with FVC < 60% or DLCO < 50% of predicted value.
  4. 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.
  5. Use of biological agents or stem cell therapy within 3 months prior to screening or within 5 half-lives of the known drug.
  6. Receipt of live or attenuated vaccines within two months prior to screening.
  7. Severe hepatic impairment, renal impairment, or hematologic abnormalities at screening.
  8. Acute or chronic infection (excluding infection complicated by finger ulceration), active infection, history of malignant tumor, or immunodeficiency disorder.
  9. Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.
  10. Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.
Tongji Hospital logoTongji Hospital
Study Responsible Party
Lingli Dong, Principal Investigator, professor; professor of medicine, Tongji Hospital
Study Central Contact
Contact: Lingli Dong, Professor, 0086-027-83665519, [email protected]
1 Study Locations in 1 Countries

Hubei

Tongji Hospital, Tong ji Medical Colledge, Wuhan, Hubei, 430000, China
Lingli Dong, Professor, Contact, 0086-027-83665519, [email protected]