Proof-of-concept study for SAR441344 (frexalimab) in relapsing 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

7 Jun 2021 → ongoing

Decision date (initial)

2024-08-08

Transition trial

Yes

Low-intervention

No

Rare-disease indication

No

Vulnerable population

Yes

Funding sources

Sanofi-Aventis Recherche & Développement

External identifiers

EU CT number

2024-513527-17-00

EudraCT number

2020-004785-19

WHO UTN

U1111-1260-3962

ClinicalTrials.gov

NCT04879628

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Pharmacodynamic, Safety, Efficacy, Therapy, Pharmacokinetic

To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions.

Secondary objectives 3

1. To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures
2. To evaluate the safety and tolerability of SAR441344
3. To evaluate pharmacokinetics of SAR441344

Conditions and MedDRA coding

Multiple Sclerosis

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. Participant must be 18 to 55 years of age inclusive, at the time of signing the informed consent.
2. The participant must have been diagnosed with RMS (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
3. The participant must have at least 1 documented relapse within the previous year, or ≥2 documented relapses within the previous 2 years, or ≥1 active Gdenhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
4. Body weight within 45 to 120 kg (inclusive) and body mass index (BMI) within the range 18.0 to 35.0 kg/m2 (inclusive) at Screening.
5. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
6. Capable of giving signed informed consent.

Exclusion criteria 13

1. The participant has been diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
2. The participant has conditions or situations that would adversely affect participation in this study.
3. The participant has a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
4. History, clinical evidence, suspicion or significant risk for thromboembolic events, as well as myocardial infarction, stroke and/or antiphosholipid syndrome and any participants requiring antithrombotic treatment.
5. Allergies to humanized monoclonal antibodies, intolerance to topical corticosteroids, or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
6. The participant has received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.
7. The participant has taken other investigational drug within 3 months or 5- halflive, whichever is longer, before the screening visit.
8. The participant has an EDSS score >5.5 at the first screening visit.
9. The participant has had a relapse in the 30 days prior to randomization.
10. Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
11. Abnormal laboratory test(s) at Screening.
12. Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (antiHBc Ab) at screening or within 3 months prior to first dose of study intervention.
13. Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Number of new Gadolinium (Gd)-enhancing T1hyperintense (GdE T1) lesions at week 12

Secondary endpoints 7

1. Total number of GdE T1 lesions at week 12
2. Adverse events (AEs) and serious adverse events (SAEs) until week 316
3. Antidrug antibodies (ADA) until week 316
4. Pharmacokinetic (PK) parameters: Cmax until week 316
5. PK parameter: tmax until week 316
6. PK parameter: AUC0-tau until week 316
7. PK parameter: t1/2z until week 316

Investigational products

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

Test 1

Placebo 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 9

Locations

5 EU/EEA countries · 13 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 51 files

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

Application history

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