FREXALIMAB for Multiple sclerosis

Inclusion criteria

• {"criterion_text":"- Group A (RMS) - The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent."}
• {"criterion_text":"- Group B (nrSPMS) - The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit)."}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Group A (RMS) - The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria."}
• {"criterion_text":"- Group A (RMS) - The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit)."}
• {"criterion_text":"- Group A (RMS) - 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."}
• {"criterion_text":"- Group B (nrSPMS) - Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria."}
• {"criterion_text":"- Group B (nrSPMS) - The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent."}
• {"criterion_text":"- Group B (nrSPMS) - The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013."}
• {"criterion_text":"- Group B (nrSPMS) - The participant must have documented evidence of disability progression observed during the 12 months before screening."}
• {"criterion_text":"- Group B (nrSPMS) - The participant must have an absence of clinical relapses for at least 24 months."}

Exclusion criteria

• {"criterion_text":"- The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria."}
• {"criterion_text":"- The participant has a history of infection or may be at risk for infection."}
• {"criterion_text":"- Fever within 28 days of the Screening Visit"}
• {"criterion_text":"- Presence of psychiatric disturbance or substance abuse"}
• {"criterion_text":"- 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."}
• {"criterion_text":"- Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia"}
• {"criterion_text":"- A history or presence of disease that can mimic MS symptoms."}
• {"criterion_text":"- The participant has a contraindication for MRI."}

Primary endpoints

• {"endpoint_text":"- Area under the curve over the interval W20 to W24 (part A) - until week 24","definition_or_measurement_approach":"Pharmacokinetic measure: area under the curve over W20 to W24; assessment period 'until week 24' (part A)."}
• {"endpoint_text":"- Trough concentration at steady state (part A) - until week 24.","definition_or_measurement_approach":"Pharmacokinetic measure: trough concentration at steady state; assessment period 'until week 24' (part A)."}

Secondary endpoints

• {"endpoint_text":"- Frexalimab plasma concentrations over time (part A) - until week 24","definition_or_measurement_approach":"Plasma concentration vs time PK profiles; assessment period until week 24 (part A)."}
• {"endpoint_text":"- Pharmacokinetic parameters: Cmax (part A) - until week 24","definition_or_measurement_approach":"Maximum observed concentration (Cmax); assessment period until week 24 (part A)."}
• {"endpoint_text":"- Pharmacokinetic parameters: Tmax (part A) - until week 24","definition_or_measurement_approach":"Time to maximum concentration (Tmax); assessment period until week 24 (part A)."}
• {"endpoint_text":"- Adverse events, SAEs, AEs leading to permanent study intervention discontinuation, AESIs, and PCSAs in laboratory tests, and vital signs during the study period - until week 96.","definition_or_measurement_approach":"Safety assessments including AEs/SAEs/AESIs, lab abnormalities and vital signs; assessment period until week 96."}
• {"endpoint_text":"- Incidence of ADAs over time (part A) - until week 96","definition_or_measurement_approach":"Assessment of anti-drug antibodies (ADA) incidence over time; assessment period until week 96 (part A)."}
• {"endpoint_text":"- Total number of Gd-enhancing T1 lesions at W12 and W24 (part A).","definition_or_measurement_approach":"MRI-derived count of gadolinium-enhancing T1 lesions at weeks 12 and 24 (part A)."}
• {"endpoint_text":"- Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months - until week 96","definition_or_measurement_approach":"Time-to-event analysis for confirmed disability worsening/progression confirmed over 3 months; assessment until week 96."}
• {"endpoint_text":"- Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study - until week 96.","definition_or_measurement_approach":"Safety monitoring related to the investigational on-body delivery device (OBDS); assessment until week 96."}
• {"endpoint_text":"- Percentage of participants that prefer SC administration over IV administration assessed by Items 13 and 14 of the PESQ at Week 48 completed by participants that switched from IV to SC in Part B - from week 24 to week 48.","definition_or_measurement_approach":"Participant preference measured by PESQ questionnaire items 13 and 14 for those switching from IV to SC in Part B; assessed between week 24 and week 48."}
• {"endpoint_text":"- Total number of GdE T1 lesions at W48 (part B) - at week 48.","definition_or_measurement_approach":"MRI count of gadolinium-enhancing T1 lesions at week 48 (part B)."}
• {"endpoint_text":"- Total number of GdE T1 lesions at W96 and yearly thereafter (part C) - at week 96 and yearly thereafter.","definition_or_measurement_approach":"MRI count of gadolinium-enhancing T1 lesions at week 96 and annually thereafter (part C)."}

Methods

• Recruitment arrangements documents available (K1-recruitment-arrangements-en) for the Member States.
• Patient-facing recruitment materials and infographics (K2-recruitment-material-patient-infographics) in multiple languages (EN, FR, NL, IT, ES) for country-specific use.
• Referral mail materials (K2-recruitment-material-referral-mail-it) indicated for Italy.
• Digital awareness material (K2-recruitment-material-digital-awareness-document-it) indicated for Italy.
• HQE single-study and multi-study recruitment materials (K2-recruitment-material-hqe-singlestudy-it; K2-recruitment-material-hqe-multistudy-it) for Italy.

Belgium

Earliest CTIS Part Ii Submission Date

09-03-2026

Latest Decision Or Authorization Date

08-04-2026

Processing Time Days

30

Number Of Sites

5

Number Of Participants

20

Italy

Earliest CTIS Part Ii Submission Date

27-02-2026

Latest Decision Or Authorization Date

10-04-2026

Processing Time Days

42

Number Of Sites

7

Number Of Participants

21

Spain

Earliest CTIS Part Ii Submission Date

12-03-2026

Latest Decision Or Authorization Date

13-04-2026

Processing Time Days

32

Number Of Sites

5

Number Of Participants

26

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Icon Clinical Research Limited

Responsibilities

Home Health Care / Nursing

Name

Endpoint Clinical Inc.

Name

Eresearchtechnology Inc.

Name

ESMS Global Limited

Responsibilities

Centralized 24-Hour Emergency System: eSMS

Third parties

• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"Home Health Care / Nursing","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Central Medical Reading or Imaging Reading","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}