A Study to Evaluate the Efficacy and Safety of BIIB059 (Litifilimab) in Adult Participants With...
Lupus ErythematosusSystemicThe primary objective of this study is to demonstrate efficacy of BIIB059 (litifilimab) compared with placebo in participants with active systemic lupus erythematosus (SLE), who are receiving background lupus standard of care (SOC) therapy in reducing disease activity. Secondary objectives of this study are to demonstrate early onset of efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing disease activity; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing joint disease activity; to demonstrate effect of BIIB059 compared with placebo in reducing oral corticosteroid (OCS) use; to demonstrate organ-specific efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing skin disease activity; to demonstrate efficacy of BIIB059 compared with placebo in participants with active SLE, who are receiving background lupus SOC therapy in reducing occurrence of flare up to Week 52; to evaluate additional efficacy of BIIB059 compared with placebo in reducing disease activity with additional disease activity measures; to evaluate the effect of BIIB059 compared with placebo in reducing OCS use; to assess the difference between BIIB059 and placebo on participant-reported health-related quality of life (HRQoL), symptoms, and impacts of SLE; to evaluate the safety and tolerability of BIIB059 in participants with active SLE; and to evaluate immunogenicity of BIIB059 in participants with active SLE.
A Study of Nipocalimab in Adult Participants With Active Systemic Lupus Erythematosus
Systemic Lupus ErythematosusThe purpose of this study is to evaluate the efficacy of nipocalimab versus placebo in participants with active systemic lupus erythematosus (SLE).
Subcutaneous Anifrolumab in Adult Patients With Systemic Lupus Erythematosus
Systemic Lupus ErythematosusThe purpose of this study is evaluating the efficacy and safety of SC antifrolumab in adult patients with moderate -to-severe SLE despite receiving standard therapy
Trial of Belimumab in Early Lupus
Lupus ErythematosusSystemic1 moreThis two year study will evaluate the effects of giving belimumab (Benlysta) to patients with Early Lupus. Early lupus is a diagnosis of lupus within 2 years. Subjects will be randomized to receive belimumab or placebo during the first year. During the second year, subjects who were randomized to belimumab will be rerandomized to continue to receive belimumab or to receive placebo. The study will look at clinical effects as well as effects on the immune system.
RIvaroxaban for Stroke Patients With AntiPhospholipid Syndrome
Antiphospholipid SyndromeSystemic Lupus Erythematosus3 moreRivaroxaban Versus Warfarin for Stroke Patients With Antiphospholipid Syndrome, With or Without SLE (RISAPS): a Randomised, Controlled, Open label, Phase II/III, Non-inferiority Trial. 140 patients will be randomised with a ratio of 1:1 to receive either: Rivaroxaban 15mg twice daily orally for 24 months or Warfarin (standard of care in the RISAPS trial) to maintain a target INR of 3.5 (range 3.0-4.0) for 24 months. The primary outcome of the trial is the rate of change in brain white matter hyperintensity (WMH) volume between baseline and 24 months follow up, assessed on brain magnetic resonance imaging (MRI), a surrogate marker of ischaemic damage.
Efficacy and Immunological Evaluation of Belimumab Plus Low Dose IL-2 in the Treatment of Systemic...
Systemic Lupus ErythematosusThe purpose of this study was to explore the clinical and immunological efficacy of belimumab plus low dose IL-2 in systemic lupus erythematosus.
A Study of Imvotamab in Severe Systemic Lupus Erythematosus
Systemic Lupus ErythematosusLupus ErythematosusThe purpose of this study is to determine the safety and tolerability of imvotamab in patients with severe systemic lupus erythematosus who have failed prior therapies. Participants will be given imvotamab through a vein (i.e., intravenously).
Systemic Lupus Erythematosus
System; Lupus ErythematosusCognition Disorder1 moreSystemic lupus erythematosus (SLE) is a chronic autoimmune and inflammatory disease. The pathogenesis of SLE results from interactions between genes, hormones, and the environment; however, the exact etiology is unknown. SLE can affect many organs and systems, including the musculoskeletal, hematological, renal, neuropsychiatric, cardiovascular and pulmonary systems, and skin. Non-specific general complaints such as malaise, fatigue, arthralgia, anxiety, depression, fever, and weight loss are evident at the onset of the disease and during the activation periods. Patients experience hopelessness due to the complexity of the symptoms and the chronic and progressive nature of the disease, and they experience deterioration in their quality of life due to the interaction of anxiety and depression findings with other symptoms. SLE is a difficult disease to manage because of the different organ and system involvement processes. In addition, these symptoms of the disease and the nature of chronic pain, including central sensitization, cause it to accompany a process that is affected by the mood of the person. Some patients present to a rheumatologist with mild symptoms, while others may present with severe, life-threatening symptoms. The onset of the disease before the age of 18 is defined as childhood onset (juvenile). Childhood-onset SLE accounts for approximately 1/5 of SLE patients. It is known that the main mechanism in the formation of the disease is the production of more than one autoantibody. Although childhood SLE (jSLE) appears to be basically the same disease with similar etiology, pathogenesis, and laboratory findings as in adults, there are differences in the frequency and severity of clinical manifestations. In this respect, the clearest finding is that children with SLE have greater disease severity and earlier disease-related organ damage than adults with SLE. Studies on the disease show that patients with jSLE have not only physical but also cognitive effects. The aim of our study is to examine the effects of exercises applied with a dual-task approach on patients' physical and cognitive status in jSLE cases.
Phase 2 Placebo-Controlled Study to Assess the Safety and Efficacy of ESK-001 in Active Systemic...
SLEThe purpose of this study is to assess the clinical efficacy, safety, PK, and PD of multiple dose levels of ESK-001 compared with placebo in adult patients with SLE.
Efficacy and Safety of Telitacicept in Early SLE
Lupus ErythematosusSystemicThe purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .