[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100650209":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":30,"centralContacts":34,"locations":40,"responsibleParty":69,"collaborators":30,"id":71,"slug":72,"hasResults":73,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":30,"eligibilityCriteria":77,"healthyVolunteers":73,"sex":78,"minAge":79,"maxAge":80,"enrollmentInfo":81,"targetDuration":30,"studyType":84,"phases":85,"briefSummary":87,"conditions":88,"keywords":30,"overallStatus":90,"whyStopped":30,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Toll Biotech Co. Ltd. (Beijing)","INDUSTRY",[8,14,18],{"label":9,"type":10,"description":11,"interventionNames":12},"TollB-001 Tablet Low Dose","EXPERIMENTAL","Eligible participants will be randomized to receive TollB-001 tablet low dose, administered once daily for 12 consecutive weeks.",[13],"Drug: TollB-001 Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"TollB-001 Tablet High Dose","Eligible participants will be randomized to receive TollB-001 tablet high dose, administered once daily for 12 consecutive weeks.",[13],{"label":19,"type":20,"description":21,"interventionNames":22},"Placebo","PLACEBO_COMPARATOR","Eligible participants will be randomized to receive matching placebo, administered once daily for 12 consecutive weeks.",[23],"Drug: Placebo",[25,31],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":30},"DRUG","TollB-001 Tablet","TollB-001 Tablets",[15,9],null,{"type":26,"name":19,"description":32,"armGroupLabels":33,"otherNames":30},"Placebo Tablets",[19],[35],{"name":36,"role":37,"phone":38,"phoneExt":30,"email":39},"Wang weili","CONTACT","010-80710966","wangweili@toll-biotech.com",[41,58],{"facility":42,"status":30,"city":43,"state":44,"zip":45,"country":46,"countryCode":47,"cosmosGeoPoint":48,"geoPoint":53,"contacts":54},"Toll Biotech, 2108-B007, No. 9 West Beisihuan Road, Haidian District, Beijing, People's Republic of China","Beijing","Beijing Municipality","100083","China","CN",{"type":49,"coordinates":50},"Point",[51,52],116.39723,39.9075,{"lat":52,"lon":51},[55],{"name":56,"role":37,"phone":57,"phoneExt":30,"email":39},"Weili Wang","86+010-80710966",{"facility":59,"status":30,"city":43,"state":44,"zip":60,"country":46,"countryCode":47,"cosmosGeoPoint":61,"geoPoint":63,"contacts":64},"Peking Union Medical College Hospital, Chinese Academy of Medical Sciences","102206",{"type":49,"coordinates":62},[51,52],{"lat":52,"lon":51},[65],{"name":66,"role":37,"phone":67,"phoneExt":30,"email":68},"Mengtao Li","010-69151188","mengtao.li@cstar.org.cn",{"type":70,"investigatorFullName":30,"investigatorTitle":30,"investigatorAffiliation":30,"oldNameTitle":30,"oldOrganization":30},"SPONSOR","100650209","phase-2-a-phase-ii-study-of-tollb-001-tablets-in-systemic-sclerosis-100650209",false,"NCT07745725","A Phase II Study of TollB-001 Tablets in Systemic Sclerosis","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","Inclusion Criteria:\n\n1. Aged 18 to 70 years (inclusive), male or female.\n2. Diagnosis of systemic sclerosis (SSc) according to the 2013 American College of Rheumatology (ACR)\u002FEuropean Alliance of Associations for Rheumatology (EULAR) classification criteria.\n3. 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.\n4. Evidence of active disease at screenin.\n5. 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.\n6. Able to swallow all study medications.\n7. 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.\n\nExclusion Criteria:\n\n1. Known hypersensitivity to any active ingredient or excipient of the study drug, or to drugs of the same class.\n2. History of scleroderma renal crisis within 6 months prior to randomization.\n3. 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.\n4. Any active malignancy or history of malignancy.\n5. Presence of severe, uncontrolled diseases.\n6. Major surgery within 8 weeks prior to randomization, or expected to undergo major surgery after enrollment.\n7. Drug or alcohol abuse or dependence at screening, or a history of drug or alcohol abuse or dependence within 6 months prior to randomization.\n8. 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.\n9. Participants who, in the investigator's judgment, are unsuitable for participation in this clinical trial.","ALL","18 Years","70 Years",{"count":82,"type":83},36,"ESTIMATED","INTERVENTIONAL",[86],"PHASE2","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).",[89],"Systemic Sclerosis (SSc)","NOT_YET_RECRUITING","2026-08-02",{"date":93,"type":94},"2026-08-04","ACTUAL",{"date":96,"type":83},"2026-08",{"date":98,"type":83},"2028-02",{"name":5,"class":6},2]