Last updated 5 days ago
Non-inferiority Study of Frexalimab Subcutaneous Administration Compared to Intravenous Administration in Adult Participants With Multiple Sclerosis
160 patients around the world
Available in Brazil, United States
Sanofi
3Research sites
160Patients around the world
This study is for people with
Multiple Sclerosis
Requirements for the patient
To 60 Years
All Gender
Medical requirements
- The participant must qualify for inclusion per either Group A or B criteria as detailed below, meeting all the inclusion criteria of the applicable group.Group A (RMS).The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).The participant must have at least 1 of the following prior to screening.1 documented relapse within the previous year OR.2 documented relapses within the previous 2 years, OR.1 documented Gd enhancing lesion on an MRI scan within the previous year.Group B (nrSPMS).Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.The participant must have documented evidence of disability progression observed during the 12 months before screening.The participant must have an absence of clinical relapses for at least 24 months.The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).Participants from Group A and Group B are eligible to be included in the study only if all of the following criteria also apply.Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.The participant has a history of infection or may be at risk for infection.Fever within 28 days of the Screening Visit.Presence of psychiatric disturbance or substance abuse.History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke, and/or antiphospholipid syndrome and any participants requiring antithrombotic treatment.Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia.A history or presence of disease that can mimic MS symptoms.The participant has a contraindication for MRI.
Sites
L2IP Instituto de Pesquisas Clínicas - Brasilia
Recruiting
INC - Instituto de Neurologia de Curitiba
Recruiting
Clínica Neurologica e Neurocirurgica de Joinville Ltda
Recruiting
StudyFrexcite
SponsorSanofi
Study typeInterventional
Conditions
Multiple Sclerosis
Requirements
To 60 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07325292
