[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Zura Bio Inc\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":50},{"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":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":29,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":44,"leadSponsor":46,"locationsCount":49},"100580894","phase-2-tibulizumab-systemic-sclerosis-understanding-and-response-evaluation-tibusure-100580894",false,"NCT06843239","Tibulizumab Systemic Sclerosis Understanding and Response Evaluation (TibuSURE)","A Phase 2, Multi-Center Study Consisting of a Randomized, Double-Blind, Placebo-Controlled Period, Followed by an Open-Label Extension Period, to Assess the Efficacy, Safety, and Tolerability of Tibulizumab in Adults With Systemic Sclerosis","Inclusion Criteria:\n\n* Male or female, 18 to 75 years of age\n* Body mass index between 18.0 and 38.0 kg\u002Fm²\n* Fulfills classification criteria for SSc according to ACR\u002FEULAR 2013 criteria\n* Has diffuse cutaneous SSc, defined as mRSS \\>0 over at least one skin area proximal to the elbows and\u002For knees, in addition to acral fibrosis\n* Has had SSc (defined as the first non-Raynaud's phenomenon (RP) symptom or sign attributed to SSc) for ≤7 years\n* mRSS ≥15 and ≤45 at screening. Additional requirements for participants ≥2 years to ≤7 years from SSc onset and RNA Polymerase III antibody positive\n* FVC \\>50% predicted\n* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥40% predicted (corrected for hemoglobin)\n\nExclusion Criteria:\n\n* Has any of the following complications:\n\n  * Left ventricular failure\n  * Pulmonary arterial hypertension\n  * Renal crisis within previous 6 months\n  * Gastrointestinal dysmotility within previous 3 months\n  * Digital ischemia with gangrene, amputation, or unscheduled hospitalization within previous 3 months\n* Current rheumatic disease other than SSc that could interfere with assessment of SSc\n* Lung disease requiring continuous oxygen therapy\n* Evidence or suspicion of active or latent tuberculosis\n* Active Crohn's Disease or ulcerative colitis","ALL","18 Years","75 Years",{"count":20,"type":21},80,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","The study is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the effects of tibulizumab over 24 weeks (Period 1) in adult participants with systemic sclerosis, followed by an open-label extension period where all active participants will receive tibulizumab and will be evaluated for an additional 28 weeks (Period 2)",[27,28],"Systemic Sclerosis (SSc)","Scleroderma",[28,27,30,31,32,33,34,35,36],"Tibulizumab","Cutaneous","Interstitial lung disease (ILD)","Autoimmune diseases","Immune system diseases","Systemic Sclerosis interstitial lung disease (SSC-ILD)","Skin Diseases","RECRUITING","2026-02-10",{"date":40,"type":41},"2026-02-12","ACTUAL",{"date":43,"type":41},"2025-02-06",{"date":45,"type":21},"2028-01",{"name":47,"class":48},"Zura Bio Inc","INDUSTRY",51,""]