Tests TollB-001 tablets in people with systemic sclerosis
Tests TollB-001 tablets against placebo in adults aged 18 to 70 with systemic sclerosis.
Plain-language title generated from the registry record
Registry title: A Phase II Study of TollB-001 Tablets in Systemic Sclerosis
Key facts
- Where
- Beijing, ChinaSee the 2 sites
- Phase
- Phase 2
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07745725, who can take part
Where in China
- Peking Union Medical College Hospital, Chinese Academy of Medical SciencesBeijing, ChinaNo longer taking part
- Toll Biotech, 2108-B007, No. 9 West Beisihuan Road, Haidian District, Beijing, People's Republic of ChinaBeijing, ChinaNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Toll Biotech Co. Ltd. (Beijing)
- Trial code
- NCT07745725
- Record updated
- 4 August 2026
- Original description
The goal of this Phase II study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of TollB-001 Tablets in adults aged 18 to 70 years (male or female) with systemic sclerosis (SSc).Read full original descriptionShow less
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase II Study to Evaluate the Efficacy and Safety of TollB-001 Tablets in Patients With Systemic Sclerosis
The goal of this Phase II study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of TollB-001 Tablets in adults aged 18 to 70 years (male or female) with systemic sclerosis (SSc).
Inclusion: Aged 18 to 70 years (inclusive), male or female; Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)/European Alliance of Associations for Rheumatology (EULAR) classification criteria; 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; Evidence of active disease at screenin; 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; Able to swallow all study medications; 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: History of scleroderma renal crisis within 6 months prior to randomization; 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; Major surgery within 8 weeks prior to randomization, or expected to undergo major surgery after enrollment; Drug or alcohol abuse or dependence at screening, or a history of drug or alcohol abuse or dependence within 6 months prior to randomization; 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; Known hypersensitivity to any active ingredient or excipient of the study drug, or to drugs of the same class; Any active malignancy or history of malignancy; Presence of severe, uncontrolled diseases; Participants who, in the investigator's judgment, are unsuitable for participation in this clinical trial.