A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
• Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening.
• Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.
• Laboratory parameters including the following:
‣ Absolute lymphocyte count (ALC) ≥0.5 × 10\^9/L
⁃ Peripheral CD19+ B cell count ≥25 cells/µL
⁃ Absolute neutrophil count (ANC) ≥1.0 × 10\^9/L
⁃ Hemoglobin (Hgb) ≥8 g/dL
⁃ Platelet count ≥75 × 10\^9/L
⁃ Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
⁃ Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN
⁃ Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2