Can a new pill ease the hardening skin of systemic sclerosis?
NCT ID NCT07745725
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This phase II trial is testing an experimental tablet called TollB-001 in adults with systemic sclerosis, a rare autoimmune disease that causes skin thickening and can affect internal organs. The study aims to see whether the drug can improve skin symptoms and overall well-being compared to a placebo. Participants will be randomly assigned to receive either TollB-001 or a placebo, and researchers will monitor safety and how the drug behaves in the body.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- TollB-001 tablets
- What this could lead to
- If TollB-001 proves effective, it could offer a new treatment option to slow or reduce skin thickening and improve quality of life for people with systemic sclerosis.
- What could go wrong
- This is an early-phase study with a small number of participants, so results may not hold up in larger trials. The drug may also cause side effects or prove no better than a placebo.
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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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 36 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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. Aged 18 to 70 years (inclusive), male or female. 2. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria. 3. Meeting the classification criteria for diffuse cutaneous systemic sclerosis (dcSSc) as defined in the 2022 Chinese Guideline for the Diagnosis and Treatment of Systemic Sclerosis. 4. Evidence of active disease at screenin. 5. Female participants of childbearing potential and male participants must use effective contraception during the study and for 3 months after the last dose of study drug. Male participants whose partners are females of reproductive potential must agree to use effective contraception and refrain from donating sperm during the study and for 3 months after the last dose. Female participants of childbearing potential must have a negative pregnancy test. 6. Able to swallow all study medications. 7. Willing and able to comply with the study protocol (e.g., able to understand and complete questionnaires, adhere to visit schedules, and take study medication) and provide signed informed consent. Exclusion Criteria: 1. Known hypersensitivity to any active ingredient or excipient of the study drug, or to drugs of the same class. 2. History of scleroderma renal crisis within 6 months prior to randomization. 3. Clinically significant chronic intermittent bleeding within 4 weeks prior to screening (e.g., active gastric antral vascular ectasia, active peptic ulcer, or duodenal ulcer), or participants at risk of bleeding. 4. Any active malignancy or history of malignancy. 5. Presence of severe, uncontrolled diseases. 6. Major surgery within 8 weeks prior to randomization, or expected to undergo major surgery after enrollment. 7. Drug or alcohol abuse or dependence at screening, or a history of drug or alcohol abuse or dependence within 6 months prior to randomization. 8. Participation in another clinical trial within 3 months prior to the date of informed consent, or planning to participate in another clinical trial during the study period. 9. Participants who, in the investigator's judgment, are unsuitable for participation in this clinical 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
2 sites. 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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Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 102206, China
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Toll Biotech, 2108-B007, No. 9 West Beisihuan Road, Haidian District, Beijing, People's Republic of China
Beijing, Beijing Municipality, 100083, China
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Other studies related to the condition(s) this trial covers.
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- Can skin biopsies unlock new treatments for scleroderma?
- Could a skin patch ease stomach pain in scleroderma?
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- A drug after transplant may stop scleroderma from coming back