NIPH Clinical Trials Search

Non-inferiority study of frexalimab subcutaneous administration compared to intravenous administration in adult participants with multiple sclerosis

Basic Information

Recruitment status	Recruiting
Health condition(s) or Problem(s) studied	Multiple sclerosis
Date of first enrollment	21/05/2026
Target sample size	160
Countries of recruitment	United States,Japan,Belgium,Japan,China,Japan
Study type	Interventional
Intervention(s)	Drug: Frexalimab (SAR441344) Pharmaceutical form: Solution for injection Route of administration: subcutaneous (SC) injection Drug: Frexalimab (SAR441344) Pharmaceutical form: Concentrate for solution for infusion Route of administration: intravenous (IV) infusion Drug: MRI contrast-enhancing preparations Route of administration: IV injection" Study Arms: Experimental: Frexalimab SC (home self-administration via on-body delivery system (OBDS), is allowed from the beginning of Part B after appropriate training and participant and Investigator agreement.) - Interventions: Frexalimab, MRI contrast-enhancing preparations Experimental: Frexalimab IV - Interventions: Frexalimab, MRI contrast-enhancing preparations

Outcome(s)

Primary Outcome

1. Area under the curve over the interval Week (W) 20 to W24 (AUCW20-W24) [Time Frame: Until Week 24] 2. Trough concentration at steady state (Ctrough,SS) [Time Frame: Until Week 24]

Secondary Outcome

1. Frexalimab plasma concentrations over time [Time Frame: Until Week 24] 2. Pharmacokinetic parameters: maximum concentration (Cmax) [Time Frame: Until Week 24] 3. Pharmacokinetic parameters: time to Cmax (Tmax) [Time Frame: Until Week 24] 4. Adverse events (AEs), serious adverse events (SAEs), AEs leading to permanent study intervention discontinuation, adverse event of special interest (AESIs), and potentially clinically significant abnormalities (PCSAs) in laboratory tests, and vital signs during the study period [Time Frame: Until Week 96] 5. Incidence of antidrug antibodies (ADAs) over time [Time Frame: Until Week 96] 6. Total number of gadolinium enhancing T1 lesions at W12 and W24 [Time Frame: At Week 12 and Week 24]

Key inclusion & exclusion criteria

Age minimum	>= 18age old
Age maximum	<= 60age old
Gender	Both
Include criteria	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 (relapsing multiple sclerosis [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. - 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 gadolinium enhancing lesion on a magnetic resonance imaging (MRI) scan within the previous year. Group B (nonrelapsing secondary progressive multiple sclerosis [nrSPMS]) - Participant must have a previous diagnosis of relapse-remitting multiple sclerosis (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 secondary progressive multiple sclerosis (SPMS). - 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.
Exclude criteria	- The participant has been diagnosed with primary progressive multiple sclerosis (MS). - 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 immunoglobulin (Ig) levels (IgG and/or IgM) below the lower limit of normal (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. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.