Pulmonary Sarcoidosis
Conditions
Brief summary
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
Detailed description
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
Interventions
DRUGXTMAB-16
XTMAB-16 infusion
Sponsors
Xentria, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
Participants are eligible to be included in the study if the following criteria apply: * 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/Day 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).
Exclusion criteria
Participants are excluded from the study if any of the following criteria apply: * 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration | Through study completion, an average of 4 years | To evaluate the long-term safety and tolerability of XTMAB-16 in participants with pulmonary sarcoidosis with or without extra-pulmonary manifestations |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Leicester Cough Questionnaire | Through study completion, an average of 4 years | To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests |
| Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Steroid Toxicity Questionnaire | Through study completion, an average of 4 years | To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests |
| Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity) | Through study completion, an average of 4 years | To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests |
| Immunogenicity (number of participants who test positive for anti drug antibodies and/or neutralizing antibodies) in the context of long-term dosing | Through study completion, an average of 4 years | To evaluate the immunogenicity of XTMAB-16 in the context of long-term dosing |
| 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 | Through study completion, an average of 4 years | To evaluate the long-term effect of XTMAB-16 on serum biomarkers important to cytokine pathway and granuloma formation in sarcoidosis |
| Durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing) | Through study completion, an average of 4 years | To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by corticosteroid dosing (maintain or lower steroid dosing) |
| Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire General | Through study completion, an average of 4 years | To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests |
| Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung | Through study completion, an average of 4 years | To evaluate the durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life or pulmonary tests |
Countries
Czechia, Poland, United Kingdom, United States
Outcome results
None listed