Pulmonary sarcoidosis with or without extrapulmonary manifestations
Conditions
Brief summary
1. Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration
Detailed description
1. Total corticosteroid dose: evaluation of accumulated dose over the first 12 weeks of the study o Average daily dose o Percentage of time in study with dose ≤ 5 mg, 2. Proportion of participants with treatment failure and time to treatment failure, as defined in Section 5.4, 3. Change in quality-of-life measures from baseline to assessment timepoints throughout the study duration: o King’s Sarcoidosis Questionnaire (KSQ) – Lung Module o KSQ – General Health Status Module o Leicester Cough Questionnaire (LCQ) o Steroid toxicity questionnaire (STQ), 4. Change in pulmonary function tests from baseline to assessment timepoints throughout the study duration: o Forced vital capacity (FVC), 5. Number and percentage of participants who test positive for XTMAB-16 anti-drug antibody (ADA), Number and percentage of participants who test positive for XTMAB-16 neutralizing antibodies (nAb), 7. Absolute and percent change in biomarkers from baseline to assessment timepoints throughout the study duration: • Angiotensin converting enzyme (ACE) • Interleukin-6 (IL-6) • Soluble interleukin-2 receptor (sIL-2R) • Soluble tumor necrosis factor alpha (sTNFα) •C-reactive protein (CRP) • Interleukin-1b (IL-1b) •Calcitriol (Vitamin D1, 25)
Interventions
Sponsors
Eligibility
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Rate of Adverse Events (AEs), including Serious Adverse Events (SAEs), and Adverse Events of Special Interests (AESIs) throughout the study duration | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Total corticosteroid dose: evaluation of accumulated dose over the first 12 weeks of the study o Average daily dose o Percentage of time in study with dose ≤ 5 mg, 2. Proportion of participants with treatment failure and time to treatment failure, as defined in Section 5.4, 3. Change in quality-of-life measures from baseline to assessment timepoints throughout the study duration: o King’s Sarcoidosis Questionnaire (KSQ) – Lung Module o KSQ – General Health Status Module o Leicester Cough Questionnaire (LCQ) o Steroid toxicity questionnaire (STQ), 4. Change in pulmonary function tests from baseline to assessment timepoints throughout the study duration: o Forced vital capacity (FVC), 5. Number and percentage of participants who test positive for XTMAB-16 anti-drug antibody (ADA), Number and percentage of participants who test positive for XTMAB-16 neutralizing antibodies (nAb), 7. Absolute and percent change in biomarkers from baseline to assessment timepoints throughout the study d | — |
Countries
Czechia, Denmark, Italy, Poland, Spain