Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Systemic Scleroderma
• Intervention / Treatment: Drug: Firsekibart injection

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lingli Dong, Professor; Phone Number: 0086-027-83665519; Email: tjhdongll@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China, 430000
      • Tongji Hospital, Tong ji Medical Colledge
      • Contact: Lingli Dong, Professor; Phone Number: 0086-027-83665519; Email: tjhdongll@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Firsekibart injection; Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time 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 Measure	Measure Description	Time 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

Collaborators and Investigators

• Sponsor: Tongji Hospital

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: March 4, 2026
• First Submitted That Met QC Criteria: March 24, 2026
• First Posted (Actual): March 30, 2026

Study Record Updates

• Last Update Posted (Actual): April 20, 2026
• Last Update Submitted That Met QC Criteria: April 15, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Systemic Scleroderma; SSc
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Scleroderma, Systemic
• Other Study ID Numbers: TJ-IRB202601060

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No