A Phase II Study of TollB-001 Tablets in Systemic Sclerosis
ConditionSystemic Sclerosis (SSc)
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorToll Biotech Co. Ltd. (Beijing)
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- TollB-001 Tablet
- Placebo
Treatment groups
36 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov