Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| XTMAB-16 Treatment | Experimental | Dose to be established in the XTMAB-16-201 Study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| XTMAB-16 | Drug | XTMAB-16 infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| Durability/maintenance of effect of XTMAB-16 as characterized by changes in quality of life measured by Kings Sarcoidosis Questionnaire Lung |
Not provided
Inclusion Criteria:
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Xentria Investigative Site | Denver | Colorado | 80206 | United States | ||
| Xentria Investigative Site |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 | 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 | 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 | Through study completion, an average of 4 years |
| Durability/maintenance of effect of XTMAB-16 measured by Pulmonary Function Test (forced vital capacity) | 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 | 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 | Through study completion, an average of 4 years |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Xentria Investigative Site | Greenville | North Carolina | 27858 | United States |
| Xentria Investigative Site | Cincinnati | Ohio | 45267 | United States |
| Xentria Investigative Site | Philadelphia | Pennsylvania | 19140 | United States |
| Xentria Investigative Site | Prague | 140 59 | Czechia |
| Xentria Investigative Site | Bielsk Podlaski | 15-044 | Poland |
| University Hospitals Coventry and Warwickshire NHS Trust | Coventry | England | CV22DX | United Kingdom |
| King's College Hospital NHS Foundation Trust | London | England | SE59RS | United Kingdom |
| Norfolk and Norwich University Hospitals NHS Foundation Trust | Norwich | England | OX3 7LE | United Kingdom |
| NHS Tayside | Perth | Scotland | PH11NX | United Kingdom |
| ID | Term |
|---|---|
| D017565 | Sarcoidosis, Pulmonary |
| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D012507 | Sarcoidosis |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006968 | Hypersensitivity, Delayed |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
Not provided
Not provided