NCT05663853

An Observational Biomarker Study in Multiple Sclerosis (MS) Patients

A Multicenter Observational Study for Ex-vivo Evaluation of the Likelihood of Response to an Experimental Tolerance Restoration Therapy in Subjects Diagnosed With Multiple Sclerosis (MS)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 137 (actual)
• Sponsor: LAPIX Therapeutics Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

All males and females between 18-70 years of age regardless of their race and ethnicity with a confirmed diagnosis of Primary Progressive Multiple Sclerosis (PPMS), Secondary Progressive Multiple Sclerosis (SPMS), and Relapse Remitting Multiple Sclerosis (RRMS) are invited to participate in this Observational study being conducted across four sites in the US. Since this is an observational study no medication/drug or treatment will be given to the participants. The investigator will be collecting information about the participant's MS disease, its progression, current medications, radiographic scans, and blood samples. This will help the investigator evaluate the biomarkers and new treatment options to better understand the MS disease process.

Detailed description

Multiple sclerosis (MS) is a chronic disabling disorder of the central nervous system with inflammatory etiology and genetic and environmental factors. It affects females more than males (2-3:1ratio). The National Multiple Sclerosis Society estimates 2.8 million people are affected by Multiple Sclerosis (MS) globally, with around 1 million patients in the US alone. This is an observational protocol designed to collect clinical and radiographical data and blood samples from patients with a confirmed diagnosis of multiple sclerosis (MS). The blood samples are collected to conduct research on the likelihood of response to LAPIX's novel small molecule therapy and to better understand the MS disease process. Since this is an observational study, no drug or device will be administered to the participants and randomization will not be performed. There will be no alterations/modifications to the current treatment plan or modalities of the enrolled participants. This multicenter study will be conducted across four US sites that will enroll 200 MS patients. The total duration of this observational study (including the screening period and Visit-1) will be 7 days. However, both the screening period and Visit-1 can be combined into a single visit. There will be no follow-up period.

Conditions

• Multiple Sclerosis, Relapsing-Remitting
• Multiple Sclerosis, Primary Progressive
• Multiple Sclerosis, Secondary Progressive

Timeline

• Start date: 2023-03-28
• Primary completion: 2024-04-30
• Completion: 2024-04-30
• First posted: 2022-12-23
• Last updated: 2024-06-11

Locations

4 sites across 1 country: United States