[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611206":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":26,"centralContacts":29,"locations":35,"responsibleParty":50,"collaborators":26,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":58,"eligibilityCriteria":59,"healthyVolunteers":54,"sex":60,"minAge":61,"maxAge":26,"enrollmentInfo":62,"targetDuration":26,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":71,"overallStatus":38,"whyStopped":26,"lastUpdateSubmitDate":72,"lastUpdatePostDateStruct":73,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":81},{"fullName":5,"class":6},"Lynk Pharmaceuticals Co., Ltd","INDUSTRY",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"LNK01001 12mg","EXPERIMENTAL","Participants receive LNK01001 12mg orally BID for 52 weeks.",[13],"Drug: LNK01001",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo","PLACEBO_COMPARATOR","Participants receive matching placebo for 16 weeks and then switch to receive LNK01001 12mg orally BID for 36 weeks.",[13,19],"Drug: Placebo",[21,27],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","LNK01001","Capsule; Oral",[9,15],null,{"type":22,"name":15,"description":24,"armGroupLabels":28,"otherNames":26},[15],[30],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},"Xiaofeng Zeng","CONTACT","13501069845","xiaofeng.zeng@cstar.org.cn",[36],{"facility":37,"status":38,"city":39,"state":26,"zip":26,"country":40,"countryCode":41,"cosmosGeoPoint":42,"geoPoint":47,"contacts":48},"Peking Union Medical College Hospital","RECRUITING","Beijing","China","CN",{"type":43,"coordinates":44},"Point",[45,46],116.39723,39.9075,{"lat":46,"lon":45},[49],{"name":31,"role":32,"phone":33,"phoneExt":26,"email":34},{"type":51,"investigatorFullName":26,"investigatorTitle":26,"investigatorAffiliation":26,"oldNameTitle":26,"oldOrganization":26},"SPONSOR","100611206","phase-3-a-study-to-evaluate-efficacy-and-safety-of-lnk01001-in-adults-with-ankylosing-spondylitis-100611206",false,"NCT07237568","A Study to Evaluate Efficacy and Safety of LNK01001 in Adults With Ankylosing Spondylitis","A Phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of LNK01001 in Adult Subjects With Active Ankylosing Spondylitis","AS","Inclusion Criteria:\n\n* Must have a clinical diagnosis of ankylosing spondylitis (AS) and meet the modified New York Criteria for AS.\n* Participant must have a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score ≥ 4 at the Screening and Baseline Visits and Must have a Total Back Pain score ≥ 4 based on a 0 - 10 numerical rating scale at the Screening and Baseline Visits.\n* Has had an inadequate response to at least 2 nonsteroidal anti-inflammatory drugs (NSAIDs) over an at least 4-week period in total at maximum recommended or tolerated doses, or has an intolerance to or contraindication for NSAIDs as defined by the Investigator.\n\nExclusion Criteria:\n\n* Total spinal ankylosis.\n* Participants with known allergies to components or excipients of the study drug.\n* Requirement of prohibited medications during the study.\n* Participants who are pregnant, nursing, or planning a pregnancy during the study period.","ALL","18 Years",{"count":63,"type":64},352,"ESTIMATED","INTERVENTIONAL",[67],"PHASE3","The aim of this study is to evaluate the efficacy and safety of LNK01001 in subjects with active ankylosing spondylitis.\n\nThe study is comprised of a 16-week randomized, double-blind, parallel-group, placebo-controlled period (the Double-Blind Period); a 36-week open-label, long-term extension period (the Open-Label Extension Period). In the Double-Blind Period, participants will be randomized in a 1:1 ratio to receive either LNK01001 or placebo twice daily (BID). Participants in the placebo group will be switched to LNK01001 BID at Week 16 in the Open-Label Extension Period.",[70],"Ankylosing Spondylitis",[23,58],"2025-11-16",{"date":74,"type":75},"2025-11-20","ACTUAL",{"date":77,"type":75},"2025-08-29",{"date":79,"type":64},"2027-09",{"name":5,"class":6},1]