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A Research Study to Evaluate the Efficacy and Safety of Cenerimod in Subjects Suffering From Systemic Lupus Erythematosus
The goal of this clinical trial is to see how well cenerimod reduces symptoms of Systemic Lupus Erythematous in adult patients with moderate to severe symptoms. The main questions it aims to answer are: - How well cenerimod works on top of the treatment already being administered. - How safe cenerimod is for adult patients with Systemic Lupus Erythematosus. Researchers will compare one dose of cenerimod and a placebo to see how well cenerimod works when it is added to the treatment already being administered. In this research study approximately 210 participants will receive cenerimod and approximately 210 participants will receive placebo for 12 months.
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ARVIS TKA vs Conventional TKA
This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.
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A Safety and Efficacy Study Evaluating CTX112 in Adult Subjects With Refractory Autoimmune Disease
This is a single-arm, open-label, multicenter, ascending dose Phase 1 study evaluating the safety and preliminary efficacy of CTX112 in adult subjects with refractory autoimmune diseases, including active systemic lupus erythematosus (SLE), systemic sclerosis (SSc), or idiopathic inflammatory myopathy (IIM).
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A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State
Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS
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Assessment of N-Acetylcysteine as Therapy for Myalgic Encephalomyelitis/Chronic Fatigue Syndrome
Chronic fatigue syndrome/myalgic encephalomyelitis (ME/CFS) is an unexplained multisymptom/multisystem disorder for which there are currently no validated treatments. The present exploratory clinical trial aims to advance our understand of the mechanisms of in situ GSH synthesis control through assessment of the response of brain GSH and plasma markers of oxidative stress to different doses of NAC in comparison to placebo, as a potential treatment for ME/CFS that would provide neuroprotection against oxidative stress by restoring cortical GSH reserves. If successful, this exploratory clinical trial would address a significant public health concern by shedding new light onto...
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Assessment of Neuroinflammation in Central Inflammatory Disorders Using [F-18]DPA-714.
The primary objective of this study is to measure the concentration and the regional brain distribution of activated brain microglia/macrophages using the PET radiopharmaceutical [F-18]DPA-714 in individuals with chronic pain and fatigue suspected to be associated with neuroinflammation. The PET tracer [F-18]DPA-714 binds to the 18 kDa translocator protein (TSPO, also known as the peripheral benzodiazepine receptor) in the mitochondria of activated microglia/macrophages and provides a non-invasive measure of neuroinflammation. The primary objective of this study is to determine if pain and fatigue patients have higher levels of neuroinflammation than HC individuals as...
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A Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE)
This is a prospective, open-label, single arm 3-year clinical study to describe the short-term and long-term efficacy and safety of belimumab in participants with autoantibody positive early SLE with ongoing disease activity despite stable initial SLE therapy.
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A Study Evaluating the Efficacy and Safety of Vixarelimab in Participants With Idiopathic Pulmonary Fibrosis and in Participants With Systemic Sclerosis-Associated Interstitial Lung Disease
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks. Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.
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A Study of Andecaliximab in Participants With Fibrodysplasia Ossificans Progressiva (FOP)
This study is researching an experimental drug called andecaliximab. The study will include pediatric and adult patients with fibrodysplasia ossificans progressiva (FOP). The study will evaluate how safe and effective andecaliximab is in patients with FOP. The study is looking at several research questions, including: - Safety of andecaliximab in participants with FOP - Whether andecaliximab reduces the number of new heterotopic bone lesions (Heterotopic Ossification; HO) - Whether andecaliximab reduces the number or severity of flare-ups - Pharmacokinetics/pharmacodynamics (PK/PD): How much study drug is in your blood at different times and its...
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A Study of CC-97540 (BMS-986353), CD19-Targeted NEX-T CAR T Cells, in Participants With Active SLE Despite Immunosuppressants (Breakfree-SLE)
The purpose of this study is to evaluate the efficacy, safety and drug levels of CC-97540 in participants with active systemic lupus erythematosus (SLE) including lupus nephritis with inadequate response to glucocorticoids and at least 2 immunosuppressants.
