A Phase 2 interventional study of XTMAB-16 in Pulmonary Sarcoidosis, sponsored by Xentria, Inc.. Active, not recruiting at 11 sites in 4 countries. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-08-21.
Sponsored by Xentria, Inc. · Phase 2, Interventional, and Treatment
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
Participants are eligible to be included in the study if the following criteria apply:
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
Dose to be established in the XTMAB-16-201 Study.
Drug: XTMAB-16
XTMAB-16 infusion
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
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
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Xentria, Inc.