Multiple SclerosisPhase 2NCT04879628

Proof-of-concept Study for SAR441344 (Frexalimab) in Relapsing Multiple Sclerosis

A Phase 2 study testing SAR441344 IV, SAR441344 SC and MRI contrast-enhancing preparations in people with Multiple Sclerosis, run by Sanofi at 37 sites in 10 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Primary Objective: To determine the efficacy of SAR441344 as measured by reduction of the number of new active brain lesions Secondary Objective: To evaluate efficacy of SAR441344 on disease activity as assessed by other MRI measures To evaluate the safety and tolerability of SAR441344 To evaluate pharmacokinetics of… Read more about this study

Who is it for?: Ages 18 to 55 years
Conditions the study is for: Multiple Sclerosis
What is being tested?: SAR441344 IV, SAR441344 SC and MRI contrast-enhancing preparations
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 129 participants
Where: 37 sitesin 10 countries
Study dates: 7 Jun 2021to 23 Aug 2027
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 55 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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 (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
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 Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
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.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Capable of giving signed informed consent.

Who cannot join

The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
The participant had conditions or situations that would adversely affect participation in this study.
The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
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.
Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.
The participant had received any of the forbidden medications/treatments within the specified time frame before any baseline assessment.

Show all 14Show fewer

The participant had taken other investigational drug within 3 months or 5-half-live, whichever is longer, before the screening visit.
The participant had an EDSS score >5.5 at the first screening visit.
The participant had a relapse in the 30 days prior to randomization.
Positive human immunodeficiency virus (HIV) serology (anti HIV1 and anti HIV2 antibodies) or a known history of HIV infection, active or in remission.
Abnormal laboratory test(s) at Screening.
Presence of Hepatitis B surface antigen (HBsAg) or anti-Hepatitis B core antibodies (anti-HBc Ab) at screening or within 3 months prior to first dose of study intervention.
Positive Hepatitis C antibody test result at screening or within 3 months prior to starting study intervention.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Trial locations and contacts

37 sites in 10 countries.

Country

City, postcode or hospital

37 sites in 10 countries

Russia8 sites

Investigational Site Number : 6430002
Kazan', 420032
Investigational Site Number : 6430007
Moscow, 117556
Investigational Site Number : 6430006
Moscow, 117997
Investigational Site Number : 6430001
Moscow, 127015
Investigational Site Number : 6430003
Saint Petersburg, 194044
Investigational Site Number : 6430005
Saint Petersburg, 197022
Investigational Site Number : 6430004
Saint Petersburg, 197110
Investigational Site Number : 6430008
Tyumen, 625000

Other trials in Russia

Ukraine7 sites

Investigational Site Number : 8040010
Dnipro, 49005
Investigational Site Number : 8040006
Dnipro, 49089
Investigational Site Number : 8040008
Ivano-Frankivsk, 76493
Investigational Site Number : 8040002
Kyiv, 01135
Investigational Site Number : 8040004
Lviv, 79013
Investigational Site Number : 8040003
Odesa, 65025
Investigational Site Number : 8040005
Vinnytsia, 21001

Other trials in Ukraine

Czechia5 sites

Investigational Site Number : 2030003
Brno, 65691
Investigational Site Number : 2030002
Hradec Králové, 50005
Investigational Site Number : 2030001
Jihlava, 58633
Investigational Site Number : 2030005
Ostrava - Poruba, 70852
Investigational Site Number : 2030004
Teplice, 415 29

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United States4 sites

The Neurological Institute Site Number : 8400004
Charlotte, North Carolina, 28204
Medical College of Wisconsin- Site Number : 8400006
Milwaukee, Wisconsin, 53226
Center for Neurology and Spine- Site Number : 8400007
Phoenix, Arizona, 85032
University of South Florida Site Number : 8400001
Tampa, Florida, 33612

Other trials in United States

Turkey (Türkiye)4 sites

Investigational Site Number : 7920004
Eskişehir, 26040
Investigational Site Number : 7920003
Istanbul, 34265
Investigational Site Number : 7920001
İzmit, 41380
Investigational Site Number : 7920002
Mersin, 33070

Other trials in Turkey (Türkiye)

Bulgaria3 sites

Investigational Site Number : 1000002
Pleven, 5809
Investigational Site Number : 1000003
Sofia, 1113
Investigational Site Number : 1000001
Sofia, 1407

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Germany2 sites

Investigational Site Number : 2760012
Leipzig, 04103
Investigational Site Number : 2760004
Münster, 48149

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Spain2 sites

Investigational Site Number : 7240004
Barcelona, Barcelona [Barcelona], 08035
Investigational Site Number : 7240002
Vigo, 36312

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Canada1 site

Investigational Site Number : 1240001
Gatineau, Quebec, J8Y 1W2

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France1 site

Investigational Site Number : 2500006
Calais, 62107

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About this study

Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis

Primary Objective:

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

Secondary Objective:

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

Read the detailed description

The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.

Conditions: Multiple Sclerosis
Being tested: SAR441344 IV, placebo IV, SAR441344 SC, placebo SC, MRI contrast-enhancing preparations
Medical subject headings: Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

SAR441344 IVDrug
Pharmaceutical form: Solution Route of administration: IV infusion
placebo IVDrug
Pharmaceutical form: Solution Route of administration: IV infusion
SAR441344 SCDrug
Pharmaceutical form: Solution Route of administration: SC injection
placebo SCDrug
Pharmaceutical form: Solution Route of administration: SC injection
MRI contrast-enhancing preparationsDrug
gadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem

Study groups in NCT04879628
Study group	Role	What they receive
Intravenous (IV) SAR441344	Experimental	SAR441344 IV Receives: Drug: SAR441344 IV; Drug: MRI contrast-enhancing preparations
IV Placebo	Placebo comparator	Placebo IV Receives: Drug: placebo IV; Drug: MRI contrast-enhancing preparations
Subcutaneous (SC) SAR441344	Experimental	SAR441344 SC Receives: Drug: SAR441344 SC; Drug: MRI contrast-enhancing preparations
SC Placebo	Placebo comparator	Placebo SC Receives: Drug: placebo SC; Drug: MRI contrast-enhancing preparations

What is being measured

The primary outcome is the main question the study is designed to answer.

Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.
Measured: Week 8 and Week 12

Secondary outcomes (7)

Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8
Cranial (brain) MRI was performed to identify number of new or enlarging T2 lesions at Week 12 relative to Week 8.
Measured: Week 8 and Week 12
Mean Total Number of GdE T1 Lesions at Week 12
Cranial (brain) MRI was performed to identify total number of GdE T1 lesions at Week 12.
Measured: Baseline (Day 1) and Week 12
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
An AE was any untoward medical occurrence in a participant or clinical study participant, temporally associated with the use of study drug, whether or not considered related to the study drug. An SAE was any untoward medical occurrence that, at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect or was an important medical event. TEAEs were defined as AEs that developed, worsened or became serious during the TE period.
Measured: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344
Blood samples were collected at specified timepoints to assess the presence of ADAs against SAR441344. Treatment-emergent ADA was defined as at least 1 treatment-induced/boosted ADA. Treatment-induced ADA was defined as ADA that developed during the TE period and without pre-existing ADA (including participants without pre-treatment samples). Treatment-boosted ADA was defined as pre-existing ADA that was boosted during the TE period to a significant higher titer than the baseline. Number of participants with treatment-emergent ADA are presented.
Measured: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Maximum Plasma Concentration (Cmax) of SAR441344
Blood samples were collected at the specified timepoints for the assessment of Cmax. Cmax was assessed by a Bayesian approach using the population pharmacokinetic (PK) model.
Measured: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Time to Maximum Plasma Concentration (Tmax) of SAR441344
Blood samples were collected at the specified timepoints for the assessment of tmax. tmax was assessed by a Bayesian approach using the population PK model.
Measured: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344
Blood samples were collected at the specified timepoints for the assessment of AUC0-tau. AUC0-tau was assessed by a Bayesian approach using the population PK model.
Measured: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 202123 Aug 2027

First posted10 May 2021
Study start7 Jun 2021
Primary completion21 Sep 2022
Study completion23 Aug 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Multiple SclerosisStudies of the same condition, open and under way.
More trials run by SanofiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 129 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04879628
Sponsor's protocol ID: ACT16877
Other IDs: U1111-1260-3962, 2024-513527-17-00, 2020-004785-19
Status last verified: Sep 2026
First submitted: 6 May 2021
Last updated: 28 Sep 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: 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

Publications

Vermersch P, Granziera C, Mao-Draayer Y, Cutter G, Kalbus O, Staikov I, Dufek M, Saubadu S, Bejuit R, Truffinet P, Djukic B, Wallstroem E, Giovannoni G; Frexalimab Phase 2 Trial Group. Inhibition of CD40L with Frexalimab in Multiple Sclerosis. N Engl J Med. 2024 Feb 15;390(7):589-600. doi: 10.1056/NEJMoa2309439.
PubMed 38354138

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase 2, Double-blind, Randomized, Placebo-controlled Study Assessing Efficacy and Safety of SAR441344, a CD40L-antagonist Monoclonal Antibody, in Participants With Relapsing Multiple Sclerosis
ClinicalTrials.gov ID: NCT04879628
Acronym / sponsor ID: ACT16877
Conditions: Multiple Sclerosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 129 participants (actual)
Lead sponsor: SanofiIndustry (pharma, biotech, devices)
Study start: 7 Jun 2021 (actual)
Primary completion: 21 Sep 2022 (actual)
Study completion: 23 Aug 2027 (estimated)
First posted: 10 May 2021 (actual)
Results: Posted 30 Sep 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Primary Objective:

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

Secondary Objective:

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

Detailed description

The duration of each participant will be no longer than 320weeks in both parts of the study, including 4 weeks of screening, at maximum 292 weeks of treatment and 24 weeks of follow-up.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 4
Model description: Part A is a 12-week, double-blind, placebo-controlled part; Part B is an open-label SAR441344 treatment part.

Arm	Type	Receives
Intravenous (IV) SAR441344	Experimental	Drug: SAR441344 IV, Drug: MRI contrast-enhancing preparationsSAR441344 IV
IV Placebo	Placebo comparator	Drug: placebo IV, Drug: MRI contrast-enhancing preparationsPlacebo IV
Subcutaneous (SC) SAR441344	Experimental	Drug: SAR441344 SC, Drug: MRI contrast-enhancing preparationsSAR441344 SC
SC Placebo	Placebo comparator	Drug: placebo SC, Drug: MRI contrast-enhancing preparationsPlacebo SC

Who may qualify

Ages: 18 to 55 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (6 listed)

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 (relapsing-remitting MS and secondary progressive MS participants with relapses) according to the 2017 revision of the McDonald diagnostic criteria.
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 Gd-enhancing brain lesion on an MRI scan in the past 6 months and prior to screening.
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.
Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

Key exclusion criteria (14 listed)

The participant was diagnosed with PPMS according to the 2017 revision of the McDonald diagnostic criteria or with non-relapsing SPMS.
The participant had conditions or situations that would adversely affect participation in this study.
The participant had a history of or currently has concomitant medical or clinical conditions that would adversely affect participation in this study.
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.
Allergies to humanized monoclonal antibodies or severe post-treatment hypersensitivity reactions other than localized injection site reaction, to any biological molecule.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
SAR441344 IVPharmaceutical form: Solution Route of administration: IV infusion	Drug	Intravenous (IV) SAR441344
placebo IVPharmaceutical form: Solution Route of administration: IV infusion	Drug	IV Placebo
SAR441344 SCPharmaceutical form: Solution Route of administration: SC injection	Drug	Subcutaneous (SC) SAR441344
placebo SCPharmaceutical form: Solution Route of administration: SC injection	Drug	SC Placebo
MRI contrast-enhancing preparationsgadolinium compound, including but not limited to Magnevist, Multihance, Prohance, or Elucirem	Drug	IV Placebo, Intravenous (IV) SAR441344, SC Placebo, Subcutaneous (SC) SAR441344

Primary outcome

Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)
Time frame: Week 8 and Week 12
Cranial (brain) MRI was performed to identify number of new GdE T1-hyperintense lesions at Week 12 relative to Week 8 MRI. Central review was used to identify new GdE T1 lesions not present at the previous MRI scans.

7 secondary outcomes

Mean Number of New or Enlarging T2 Lesions at Week 12 Relative to Week 8
Time frame: Week 8 and Week 12
Mean Total Number of GdE T1 Lesions at Week 12
Time frame: Baseline (Day 1) and Week 12
Double-Blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs)
Time frame: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Double-Blind Period: Number of Participant With Anti-Drug Antibodies (ADAs) Against SAR441344
Time frame: From first dose of study drug (Day 1) up to 12 weeks (DB TE period)
Maximum Plasma Concentration (Cmax) of SAR441344
Time frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Time to Maximum Plasma Concentration (Tmax) of SAR441344
Time frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)
Area Under the Curve Over the Dosing Interval (AUC0-tau) of SAR441344
Time frame: After dose on Day 1 (first dose) and Weeks 8 (IV arm) and 10 (SC arm) (last dose)

Results and safety

Results posted to the registry on 30 Sep 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
SC Placebo	14	14
IV Placebo	12	12
SC SAR441344 300 mg	51	49
IV SAR441344 1200 mg	52	50

Primary outcome: Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI)

Time frame: Week 8 and Week 12. Least squares mean (95% Confidence Interval). Unit: number of new GdE T1 lesions per month

Measure	Placebo n = 22	SC SAR441344 300 mg n = 45	IV SAR441344 1200 mg n = 47
Value	1.4 (0.62 to 2.98)	0.3 (0.13 to 0.59)	0.2 (0.06 to 0.39)

Placebo vs SC SAR441344 300 mg: Rate ratio: 0.21 (95% CI 0.08 to 0.56)
Placebo vs IV SAR441344 1200 mg: Rate ratio: 0.11 (95% CI 0.03 to 0.38)

Population analysed: The efficacy population included all participants from the randomized population who took all Part A doses of study drug (1 SC dose skipped was allowed) and with an evaluable primary endpoint. As pre-specified in the statistical analysis plan (SAP), data for placebo arm is presented by pooling SC and IV placebo arms.

7 secondary outcomes are reported in the full results.

Adverse events

Time frame: AEs and SAEs were collected from first dose of study drug (Day 1) up to 12 weeks (DB TE period). All-cause mortality (deaths) were collected from screening (Week -4) up to PCD of 21 September 2022, approximately up to 67 weeks. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SC Placebo	0 of 14 (0%)	5 of 14 (35.7%)	0 of 14
IV Placebo	0 of 12 (0%)	3 of 12 (25%)	0 of 12
SC SAR441344 300 mg	0 of 51 (0%)	9 of 51 (17.6%)	0 of 51
IV SAR441344 1200 mg	0 of 52 (0%)	6 of 52 (11.5%)	0 of 52

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38354138Vermersch P, Granziera C, Mao-Draayer Y, Cutter G, Kalbus O, Staikov I, Dufek M, Saubadu S, Bejuit R, Truffinet P, Djukic B, Wallstroem E, Giovannoni G; Frexalimab Phase 2 Trial Group. Inhibition of CD40L with Frexalimab in Multiple Sclerosis. N Engl J Med. 2024 Feb 15;390(7):589-600. doi: 10.1056/NEJMoa2309439.
ACT16877 Plain Language Results SummariesLink provided by the sponsor.
Individual participant dataSharing planned: Yes. 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

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Clinical Sciences & Operations study director

Sanofi

37 sites in 10 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing SAR441344 IV, SAR441344 SC and MRI contrast-enhancing preparations in people with Multiple Sclerosis, run by Sanofi at 37 sites in 10 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 37 sites in Russia, Ukraine, Czechia, United States, Turkey (Türkiye) and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 30 Sep 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Number of New Gadolinium (Gd)-Enhancing T1--Hyperintense (GdE T1) Lesions at Week 12 Relative to Week 8 as Measured by Brain Magnetic Resonance Imaging (MRI) (time frame: Week 8 and Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04879628, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.