[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Lynk Pharmaceuticals Co., Ltd\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":42},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":28,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":5},"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":20,"type":21},352,"ESTIMATED","INTERVENTIONAL",[24],"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.",[27],"Ankylosing Spondylitis",[29,15],"LNK01001","RECRUITING","2025-11-16",{"date":33,"type":34},"2025-11-20","ACTUAL",{"date":36,"type":34},"2025-08-29",{"date":38,"type":21},"2027-09",{"name":40,"class":41},"Lynk Pharmaceuticals Co., Ltd","INDUSTRY",""]