Merck Serono (Beijing) Pharmaceutical R&D Co., Ltd.

Primary objective: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE. Secondary objectives: To evaluate the long-term safety and tolerability of enpatoran in subjects with SCLE, DLE and/or SLE and the long-term effectiveness of enpatoran in disease control; Tertiary/exploratory objectives: To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SCLE, DLE and/or SLE; To evaluate the long-term effectiveness of enpatoran in disease control in subjects with SLE; To evaluate the long-term effectiveness of enpatoran in patient-reported symptoms and functional status in subjects with SCLE, DLE and/or SLE; To evaluate the long-term effectiveness of enpatoran in patient-reported symptoms and functional status in subjects with active SLE; To study the effects of enpatoran on biomarkers in subjects with active SLE; To study the effects of enpatoran on immune cell subsets and immunoglobulins; To study the effects of enpatoran on PD biomarkers; To collect enpatoran plasma concentration data by sparse PK sampling; To evaluate the long-term effects of enpatoran on vaccine immune status. To evaluate the effects of Enpatoran versus placebo on erythema in subjects with active lupus rash.

Primary objective: To confirm the safety and tolerability of M1774 in Chinese subjects with solid tumors based on the global RDE established in Part A1. To determine the local RDE if the global RDE cannot be confirmed in Chinese subjects with solid tumors. Secondary objective: To investigate the PK characteristics of M1774 monotherapy. Tertiary/exploratory objective: To investigate the relationship between exposure and QTc. To identify germline genetic polymorphisms that may predict differences in the PK characteristics, safety, and/or efficacy of M1774. To evaluate the clinical effectiveness of M1774 in treating subjects with solid tumors.

The objective of this study was to demonstrate the efficacy of xevinapant over placebo when added to a radiotherapy regimen in high-risk subjects with surgically resected LA SCCHN who were ineligible for concurrent cisplatin-based chemoradiotherapy.