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Last Updated: 01/21/2025
A Randomized, Double-blind, Phase 3 Study Comparing Efficacy and Safety of Frexalimab (SAR441344) to Placebo in Adult Participants With Nonrelapsing Secondary Progressive Multiple Sclerosis
Summary: The purpose of this randomized, double-blind, placebo-controlled, parallel group study is to determine the efficacy of frexalimab in delaying the disability progression and the safety up to approximately 51 months administration of study intervention compared to placebo in male and female participants with nrSPMS (aged 18 to 60 years at the time of enrollment). People diagnosed with nrSPMS are eli...
Comprehensive Multimodal Analysis of Patients With Neuroimmunological Diseases of the CNS
Summary: Inflammatory or degenerative diseases of the brain and spinal cord, such as multiple sclerosis, may be related to problems with an individual s immune system. However, more information is needed on the ways in which the cells of the immune system interact with the central nervous system (CNS). This study will compare tests performed on both healthy volunteers and individuals who have signs or symp...
Targeting Residual Activity By Precision, Biomarker-Guided Combination Therapies of Multiple Sclerosis (TRAP-MS)
Background: In people with multiple sclerosis (MS), brain and cerebrospinal fluid (CSF) biomarkers indicate inflammation or disease. Researchers want to see if 4 drugs given alone or combined affect MS biomarkers. They want to see if a change in biomarker levels can predict which drugs a person with MS might respond to.
A Comprehensive Clinical, Microbiological and Immunological Assessment of Patients With Suspected Post Treatment Lyme Disease Syndrome and Selected Control Populations
Summary: This study will determine whether patients who have been infected with the Lyme bacteria, Borrelia burgdorferi, and treated with antibiotics still have the bacteria alive inside them and whether it is causing their symptoms. The information from this study may serve as a basis for developing stringent diagnostic criteria for Lyme disease and the establishment of future treatment trials. Individual...
The Wearing-off Effect of Anti-CD20 Therapies in Patients With Multiple Sclerosis
Summary: The nature, intensity, and prevalence of this wearing-off effect remain poorly understood. To our knowledge, there is no consensus in the literature on what symptoms constitute a wearing-off effect, nor is there a single validated scale that measures wearing-off effect. The current study will explore the wearing-off effect associated with OCR and OMB, using a variety of validated scales assessing ...
A Phase 1b, Open-label Study of PIPE-791 to Determine Brain and Lung Lysophosphatidic Acid Receptor 1 (LPA1) Occupancy, by [18F] PIPE-497 PET Imaging in Healthy Volunteers, Volunteers With Progressive Multiple Sclerosis, and Volunteers With Idiopathic Pulmonary Fibrosis
Summary: This is a study of PIPE-791, an investigational study drug to treat progressive multiple sclerosis (MS) and idiopathic pulmonary fibrosis (IPF). The purpose of this study is to find out how much of the study drug gets into the brain and lung, and what the side effects and blood levels of the study drug are in healthy volunteers and patients. Participants will: * Take a single dose of the study dru...
Multicenter, Phase Ib/IIa Study on the Safety and Efficacy of Autologous Peptide-coupled Red Blood Cells in Patients with Relapsing Remitting Multiple Sclerosis - RED4MS Trial
Summary: RED4MS is a clinical trial to assess the safety, tolerability and efficacy of autologous peptide coupled red blood cells (CLS12311) in patients with relapsing remitting multiple sclerosis (RRMS). CLS12311 consists of autologous red blood cells (RBCs) chemically coupled with antigenic peptides and aims to treat RRMS by induction of antigen-specific immune tolerance.
Post-Authorization Safety Study for Assessment of Pregnancy and Infant Outcomes in Patients Treated With Kesimpta (Ofatumumab) Using OTIS Observational Pregnancy Surveillance Program and DMSKW Registry
Summary: The Kesimpta Pregnancy Registry is an observational, exposure cohort designed study to examine pregnancy and infant outcomes in women and infants who are exposed to Kesimpta (ofatumumab) during pregnancy to treat MS.
This is a Non-interventional, Prospective, Multicenter Study Conducted in France. The Primary Objective of This Study is to Describe the Quality of Life of MS Patients After Initiation of Treatment With Ofatumumab.
Summary: SEPROS is a non-interventional study, based on primary data collection of MS adult patients who initiated ofatumumab as per neurologist practice and regardless of the study protocol.
A Cross-sectional Study to Assess the Effectiveness and Safety of Ofatumumab (Kesimpta®) in Patients With Relapsing Multiple Sclerosis in the Spanish Clinical Practice: the CRONOS-MS Study.
Summary: This is a non-interventional, cross-sectional, multicentric, and nationwide study, based on primary and secondary data collection.
Ofatumumab in Portuguese Multiple Sclerosis Patients - an Observational Study
Summary: This non-interventional study will compare the effect of Ofatumumab treatment between patients that began Ofatumumab within the 3 years after Multiple Sclerosis diagnosis and patients that began Ofatumumab with more than 3 years of Multiple Sclerosis diagnosis in a real-world setting in Portugal.
A Non-interventional Study Evaluating Clinical Utility and Implications on Improved Patient Management of Serum Neurofilament as a Prognostic Marker for Disease Activity in Patients With Relapsing Multiple Sclerosis (FILAXOS)
Summary: This is a prospective, multicenter, observational, non-interventional study (NIS) in patients with Multiple Sclerosis (MS) and routinely assessed serum neurofilament light (sNfL) values in Germany
Last Updated: 01/21/2025