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

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Sanofi-Aventis Recherche & Developpement

Participant type

Patients

Age range

18-64 years

Gender

Male and Female

Therapeutic area

Diseases [C] - Nervous System Diseases [C10]

Trial duration

20 Apr 2026 → ongoing

Decision date (initial)

2026-04-08

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Développement

External identifiers

EU CT number

2024-519304-28-00

WHO UTN

U1111-1306-7563

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Efficacy, Pharmacokinetic, Therapy

To determine the non-inferiority of frexalimab SC administration compared to frexalimab IV administration as measured by pharmacokinetic parameters (part A)

Secondary objectives 6

1. To characterize the pharmacokinetics of frexalimab SC and IV administration（part A).
2. To evaluate safety and tolerability of frexalimab SC and IV administration (part A and B).
3. To evaluate efficacy of frexalimab SC administration compared to frexalimab IV administration on disease activity as assessed by MRI measures and clinical endpoints (part A and B and C).
4. To assess the safety of the (investigational) device injector (OBDS) (part A and B and C).
5. To evaluate the participant’s preference for SC versus IV administration (part B).
6. To evaluate the long-term safety and tolerability of frexalimab SC administration (part C).

Conditions and MedDRA coding

Multiple Sclerosis

Regulatory references

Scientific advice from competent authorities

European Medicines Agency

Plan to share IPD

Yes

IPD plan description

‘Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org’

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 11

1. Group A (RMS) - The participant must be 18 to 55 years of age, inclusive, at the time of signing the informed consent.
2. Group A (RMS) - The participant must have been diagnosed with RMS in accordance with the 2017 revised McDonald criteria.
3. Group A (RMS) - The participant must have an Expanded Disability Status Scale (EDSS) score of ≤5.5 at the first visit (Screening Visit).
4. 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.
5. Group B (nrSPMS) - Participant must have a previous diagnosis of RRMS in accordance with the 2017 revised McDonald criteria.
6. Group B (nrSPMS) - The participant must be 18 to 60 years of age, inclusive, at the time of signing the informed consent.
7. Group B (nrSPMS) - The participant must have a current diagnosis of SPMS in accordance with the clinical course criteria revised in 2013.
8. Group B (nrSPMS) - The participant must have documented evidence of disability progression observed during the 12 months before screening.
9. Group B (nrSPMS) - The participant must have an absence of clinical relapses for at least 24 months.
10. Group B (nrSPMS) - The participant must have an EDSS score between 3.0 and 6.5 points, inclusive, at the first visit (Screening Visit).
11. 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.

Exclusion criteria 8

1. The participant has been diagnosed with primary progressive MS according to the 2017 revision of the McDonald diagnostic criteria.
2. The participant has a history of infection or may be at risk for infection.
3. Fever within 28 days of the Screening Visit
4. Presence of psychiatric disturbance or substance abuse
5. 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.
6. Current hypogammaglobulinemia defined by Ig levels (IgG and/or IgM) below the LLN at screening or a history of primary hypogammaglobulinemia
7. A history or presence of disease that can mimic MS symptoms.
8. The participant has a contraindication for MRI.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Area under the curve over the interval W20 to W24 (part A) - until week 24
2. Trough concentration at steady state (part A) - until week 24.

Secondary endpoints 11

1. Frexalimab plasma concentrations over time (part A) - until week 24
2. Pharmacokinetic parameters: Cmax (part A) - until week 24
3. Pharmacokinetic parameters: Tmax (part A) - until week 24
4. 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.
5. Incidence of ADAs over time (part A) - until week 96
6. Total number of Gd-enhancing T1 lesions at W12 and W24 (part A).
7. Time to onset of confirmed disability worsening (CDW)/ confirmed disability progression(CDP) confirmed over 3 months - until week 96
8. Medical device AEs, ADEs, SAEs, SADEs and device deficiencies throughout the study - until week 96.
9. 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.
10. Total number of GdE T1 lesions at W48 (part B) - at week 48.
11. Total number of GdE T1 lesions at W96 and yearly thereafter (part C) - at week 96 and yearly thereafter.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Sanofi-Aventis Recherche & Developpement

Sponsor organisation

Sanofi-Aventis Recherche & Developpement

Address

82 Avenue Raspail

City

Gentilly

Postcode

94250

Country

France

Scientific contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Public contact point

Organisation

Sanofi-Aventis Recherche & Developpement

Contact name

Clinical Sciences and Operations

Third parties 6

Locations

3 EU/EEA countries · 17 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 50 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications