Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

NCT07502105 | Not Yet Recruiting

• 1 other identifier: TJ-IRB202601060
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Systemic Scleroderma

Keywords

Systemic Scleroderma; SSc

Outcome Measures

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.

  Week 12

Secondary Outcomes (6)

• Change in modified Rodnan skin score (mRSS) from baseline

  Week 16, 24

• Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline

  Week 12, 16, 24

• Change from baseline in pulmonary function (FVC)

  Week 12, 16, 24

• Change from baseline in pulmonary function (DLCO)

  Week 12, 16, 24

• Change in serum IL-1β levels from baseline

  Week 12, 16, 24

Study Arms (1)

Firsekibart injection

EXPERIMENTAL

Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8.

Drug: Firsekibart injection

Interventions

Firsekibart injection DRUG

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.

Firsekibart injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.
• Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.
• Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.

Sponsors & Collaborators

• Tongji Hospital: lead

Study Sites (1)

Tongji Hospital, Tong ji Medical Colledge

Wuhan, Hubei, 430000, China

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Central Study Contacts

Lingli Dong, Professor

CONTACT

0086-027-83665519; tjhdongll@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor; professor of medicine

Study Record Dates

• First Submitted: March 4, 2026
• First Posted: March 30, 2026
• Study Start: March 2, 2026
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 30, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)