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
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
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
31
XTMAB-16 infusion
Xentria Investigative Site
Denver, Colorado, United States
Xentria Investigative Site
Chicago, Illinois, United States
Xentria Investigative Site
Greenville, North Carolina, United States
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
Time frame: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing)
Time frame: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Time frame: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Time frame: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Time frame: Through study completion, an average of 4 years
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Xentria Investigative Site
Cincinnati, Ohio, United States
Xentria Investigative Site
Philadelphia, Pennsylvania, United States
Xentria Investigative Site
Prague, Czechia
Xentria Investigative Site
Bielsk Podlaski, Poland
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, England, United Kingdom
King's College Hospital NHS Foundation Trust
London, England, United Kingdom
Norfolk and Norwich University Hospitals NHS Foundation Trust
Norwich, England, United Kingdom
...and 1 more locations
Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Time frame: Through study completion, an average of 4 years
Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity)
To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests
Time frame: Through study completion, an average of 4 years
Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing
To evaluate the immunogenicity of XTMAB-16 in the context of long-term dosing
Time frame: Through study completion, an average of 4 years
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
Time frame: Through study completion, an average of 4 years