[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06169397":3,"trial-entities:NCT06169397":163,"trial-summary:NCT06169397":166},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":7,"conditions":17,"keywords":19,"study_type":20,"primary_purpose":21,"phases":22,"enrollment_info":24,"interventions":27,"primary_outcomes":34,"secondary_outcomes":39,"sex":60,"minimum_age":61,"maximum_age":62,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":73,"locations":76,"central_contacts":159,"overall_officials":160,"references":161,"see_also_links":162},"NCT06169397","XTMAB-16-202","An Open-label Extension Study of XTMAB-16 in Patients With Pulmonary Sarcoidosis","A Long-term Multicenter Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement","ENROLLING_BY_INVITATION","2026-11","2026-07","2026-07-30","2024-03-01","Xentria, Inc.","INDUSTRY",null,"Open-label Study to Evaluate the Long-term Safety and Durability of Effect of XTMAB-16 in Patients With Pulmonary Sarcoidosis With or Without Extra-pulmonary Involvement",[18],"Pulmonary Sarcoidosis",[],"INTERVENTIONAL","TREATMENT",[23],"PHASE2",{"count":25,"type":26},94,"ESTIMATED",[28],{"type":29,"name":30,"description":31,"armGroupLabels":32},"DRUG","XTMAB-16","XTMAB-16 infusion",[33],"XTMAB-16 Treatment",[35],{"measure":36,"description":37,"timeFrame":38},"Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration","To evaluate the long-term safety and tolerability of XTMAB-16 in participants with pulmonary sarcoidosis with or without extra-pulmonary manifestations","Through study completion, an average of 4 years",[40,43,46,48,50,52,54,57],{"measure":41,"description":42,"timeFrame":38},"Durability\u002Fmaintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)","To evaluate the durability\u002Fmaintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)",{"measure":44,"description":45,"timeFrame":38},"Durability\u002Fmaintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung","To evaluate the durability\u002Fmaintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests",{"measure":47,"description":45,"timeFrame":38},"Durability\u002Fmaintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General",{"measure":49,"description":45,"timeFrame":38},"Durability\u002Fmaintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire",{"measure":51,"description":45,"timeFrame":38},"Durability\u002Fmaintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire",{"measure":53,"description":45,"timeFrame":38},"Durability\u002Fmaintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)",{"measure":55,"description":56,"timeFrame":38},"Immunogenicity (number of participants who test positive for anti drug antibodies and\u002For neutralizing antibodies) in the context of long-term dosing","To evaluate the immunogenicity of XTMAB-16 in the context of long-term dosing",{"measure":58,"description":59,"timeFrame":38},"Long-term effect of XTAMB-16 on serum biomarkers important to cytokine pathway and granuloma formation (ACE, IL-6, sIL-2R, sTNFa, CRP, IL-1b, calcitriol) in sarcoidosis","To evaluate the long-term effect of XTMAB-16 on serum biomarkers important to cytokine pathway and granuloma formation in sarcoidosis","ALL","18 Years","80 Years",false,{"inclusion":65,"exclusion":68,"raw_text":72},[66,67],"Completion of XTMAB-16-201 study: completion of Week 12 (Part A) or Week 24 (Part B) assessments.","Participants from XTMAB-16-201 Part A and Part B should be on a stable steroid dose for at least 2 weeks prior to informed consent\u002FDay 1 of XTMAB-16-202 (Day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of XTMAB 16 201 ± 2 weeks).",[69,70,71],"Evidence of treatment-related AEs requiring treatment discontinuation per XTMAB-16-201 protocol observed in XTMAB-16-201 study.","Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition.","Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study.","Inclusion Criteria:\n\nParticipants are eligible to be included in the study if the following criteria apply:\n\n* Completion of XTMAB-16-201 study: completion of Week 12 (Part A) or Week 24 (Part B) assessments.\n* Participants from XTMAB-16-201 Part A and Part B should be on a stable steroid dose for at least 2 weeks prior to informed consent\u002FDay 1 of XTMAB-16-202 (Day 1 should occur at the next scheduled dosing visit on the assigned dose frequency cohort of XTMAB 16 201 ± 2 weeks).\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Evidence of treatment-related AEs requiring treatment discontinuation per XTMAB-16-201 protocol observed in XTMAB-16-201 study.\n* Evidence of treatment failure observed in XTMAB-16-201 study per protocol definition.\n* Pregnant or breastfeeding women or women who are planning to be pregnant during the course of the study.",[74,75],"ADULT","OLDER_ADULT",[77,86,93,100,107,114,121,128,137,144,151],{"facility":78,"city":79,"state":80,"zip":81,"country":82,"geoPoint":83},"Xentria Investigative Site","Denver","Colorado","80206","United States",{"lat":84,"lon":85},39.73915,-104.9847,{"facility":78,"city":87,"state":88,"zip":89,"country":82,"geoPoint":90},"Chicago","Illinois","60611",{"lat":91,"lon":92},41.85003,-87.65005,{"facility":78,"city":94,"state":95,"zip":96,"country":82,"geoPoint":97},"Greenville","North Carolina","27858",{"lat":98,"lon":99},35.61266,-77.36635,{"facility":78,"city":101,"state":102,"zip":103,"country":82,"geoPoint":104},"Cincinnati","Ohio","45267",{"lat":105,"lon":106},39.12711,-84.51439,{"facility":78,"city":108,"state":109,"zip":110,"country":82,"geoPoint":111},"Philadelphia","Pennsylvania","19140",{"lat":112,"lon":113},39.95238,-75.16362,{"facility":78,"city":115,"zip":116,"country":117,"geoPoint":118},"Prague","140 59","Czechia",{"lat":119,"lon":120},50.08804,14.42076,{"facility":78,"city":122,"zip":123,"country":124,"geoPoint":125},"Bielsk Podlaski","15-044","Poland",{"lat":126,"lon":127},52.76512,23.18647,{"facility":129,"city":130,"state":131,"zip":132,"country":133,"geoPoint":134},"University Hospitals Coventry and Warwickshire NHS Trust","Coventry","England","CV22DX","United Kingdom",{"lat":135,"lon":136},52.40656,-1.51217,{"facility":138,"city":139,"state":131,"zip":140,"country":133,"geoPoint":141},"King's College Hospital NHS Foundation Trust","London","SE59RS",{"lat":142,"lon":143},51.50853,-0.12574,{"facility":145,"city":146,"state":131,"zip":147,"country":133,"geoPoint":148},"Norfolk and Norwich University Hospitals NHS Foundation Trust","Norwich","OX3 7LE",{"lat":149,"lon":150},52.62783,1.29834,{"facility":152,"city":153,"state":154,"zip":155,"country":133,"geoPoint":156},"NHS Tayside","Perth","Scotland","PH11NX",{"lat":157,"lon":158},56.39522,-3.43139,[],[],[],[],{"nct_id":4,"conditions":164,"biomarkers":165},[18],[],{"nct_id":4,"found":63,"summary":15,"prompt_version":15}]