New antibody drug firsekibart tested for scleroderma skin thickening
NCT ID NCT07502105
First seen Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-stage trial will test a new drug called firsekibart in 30 people with systemic sclerosis (scleroderma), a disease that causes skin thickening and organ damage. Firsekibart is an antibody that blocks a protein involved in inflammation. The study will measure changes in skin thickness over time and compare results to past patient data to see if the drug is safe and effective.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- firsekibart (a lab-made antibody that blocks IL-1β, a protein involved in inflammation)
- What this could lead to
- If it works, this could point toward a new treatment option for systemic sclerosis, potentially reducing skin thickening and improving quality of life.
- What could go wrong
- This is a very early, small, exploratory trial with only 30 participants and no placebo group. Results may not be generalizable, and the drug's safety and effectiveness are not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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May 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Tongji Hospital, Tong ji Medical Colledge
Wuhan, Hubei, 430000, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can a One-Time cell therapy reset the immune system in autoimmune disease?
- Can a new pill ease the hardening skin of systemic sclerosis?
- New antibody drug aims to halt Scleroderma's grip
- Could blocking TL1A stop skin scarring in scleroderma? early lab study hints at possibility
- CAR-T therapy takes on lupus and scleroderma in early trial
- Tiny particles may hold clues to autoimmune diseases