A study of XTMAB-16 in patients with pulmonary sarcoidosis
Participant between 18 and 80 years (inclusive) of age.
Weighs between 45 and 160 kg (99 to 353 lbs) at Screening.
Diagnosis of pulmonary sarcoidosis (at least 6 months before Screening) using the 2020 American Thoracic Society (ATS) Clinical Practice Guideline (Crouser et al, 2020), the European Respiratory Society (ERS) or the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) criteria including a compatible clinical and radiologic presentation with other causes of granulomatous disease ruled out (cutaneous and ocular involvement permitted).
mMRC Dyspnea Scale of ≥1.
Pregnant or breastfeeding women or women who are planning to become pregnant during the study.
Known potentially significant fibrotic disease and/or active inflammation contained solely in the hilar region as shown by HRCT, confirmed by a central reader. Participants with current active inflammation in the hilar region with concurrent inflammation outside the hilar region may be included. A historical HRCT performed within 6 months of screening may be submitted for diagnostic confirmation by central review. If a participant's last HRCT was from >6 months of screening, an HRCT should be performed during screening for diagnostic confirmation by central review. Note: Significant fibrotic disease is defined as >20% fibrosis on HRCT.
Clinically significant extra-pulmonary sarcoidosis requiring systemic therapy as determined by the Investigator.
Any therapy with an anti-TNFα monoclonal antibody (e.g., infliximab, adalimumab, golimumab and their biosimilars) within 6 months.
Parallel
XTMAB-16
DrugInfusion
Placebo
DrugInfusion
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 24
To establish efficacy of XTMAB-16 as measured by FVC (mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations(mL) in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Quality of Life King's Sarcoidosis Questionnaire-Lung (KSQ-L) mean change
To further establish efficacy of XTMAB-16 as measured by quality of life in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
Proportion of participants experiencing no independently adjudicated worsening (exacerbation) events through Week 52
To further establish efficacy of XTMAB-16 as measured by disease control in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
King's Sarcoidosis Questionnaire - General (KSQ-G)
To further establish efficacy of XTMAB-16 as measured by quality of life in participants with pulmonary sarcoidosis with or without extrapulmonary manifestations
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