A Phase II Study of TollB-001 Tablets in Systemic Sclerosis

Starting soon · Phase 2 · Has a placebo group

Conditions studied: Systemic Sclerosis (SSc)

In brief

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).

Key facts

Study ID

NCT07745725

Run by

Toll Biotech Co. Ltd. (Beijing)

People needed

36

Starts

2026-08-01

Expected to finish

2028-02-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Known hypersensitivity to any active ingredient or excipient of the study drug, or to drugs of the same class.
• 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.
• Any active malignancy or history of malignancy.
• Presence of severe, uncontrolled diseases.
• 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.
• Participants who, in the investigator's judgment, are unsuitable for participation in this clinical trial.

Where it is running

• Toll Biotech, 2108-B007, No. 9 West Beisihuan Road, Haidian District, Beijing, People's Republic of China — Beijing, Beijing Municipality, China
• Peking Union Medical College Hospital, Chinese Academy of Medical Sciences — Beijing, Beijing Municipality, China

Full record on ClinicalTrials.gov

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