Systemic SclerodermaNCT07502105
Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
A study testing Firsekibart injection in people with Systemic Scleroderma, run by Tongji Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Scleroderma
- What is being tested?
- Firsekibart injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2026to 1 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Tongji Hospital, Tong ji Medical Colledge
Wuhan, Hubei, 430000
Lingli Dong, Professor, 0086-027-83665519, tjhdongll@163.com
About this study
Official title: 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.
- Conditions
- Systemic Scleroderma
- Being tested
- Firsekibart injection
- Keywords
- Systemic Scleroderma, SSc
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Firsekibart injectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Firsekibart injection | Experimental | Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8. Receives: Drug: Firsekibart injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Week 12
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Week 12, 16, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2026
- Study start1 May 2026 (estimated)
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerodermaStudies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lingli Dong, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07502105
- Sponsor's protocol ID
- TJ-IRB202601060
- Status last verified
- Mar 2026
- First submitted
- 4 Mar 2026
- Last updated
- 20 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT07502105
- Acronym / sponsor ID
- TJ-IRB202601060
- Conditions
- Systemic Scleroderma
- Keywords
- Systemic Scleroderma, SSc
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 May 2026 (estimated)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Dec 2028 (estimated)
- First posted
- 30 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Firsekibart injection | Experimental | Drug: Firsekibart injectionEligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Firsekibart injectionFirsekibart, 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. | Drug | Firsekibart injection |
Primary outcome
Change in the modified Rodnan Skin Score (mRSS) from baseline
Time frame: Week 12
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.
6 secondary outcomes
Change in modified Rodnan skin score (mRSS) from baseline
Time frame: Week 16, 24
Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline
Time frame: Week 12, 16, 24
Change from baseline in pulmonary function (FVC)
Time frame: Week 12, 16, 24
Change from baseline in pulmonary function (DLCO)
Time frame: Week 12, 16, 24
Change in serum IL-1β levels from baseline
Time frame: Week 12, 16, 24
Change in serum IL-6 levels from baseline
Time frame: Week 12, 16, 24
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Firsekibart injection in people with Systemic Scleroderma, run by Tongji Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 20 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lingli Dong, Professor (0086-027-83665519, tjhdongll@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the modified Rodnan Skin Score (mRSS) from baseline (time frame: Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2026.