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Emerging treatmentsRegistered study in peopleParticipation in Greece reported; no results

Phase 3 study in secondary progressive MS

REMASTER: the EU register reports recruitment starting in Greece

Published by MyelinWatch:

Study sponsor
Novartis

Greek centres and contacts ↓

What happened

The EU REMASTER record lists Greece as a country accepting participants, with a reported start on 18 September 2026. It names seven Greek centres. REMASTER compares remibrutinib with placebo in secondary progressive multiple sclerosis (MS). The date is a country-level registry report, not proof that every centre began accepting people on that day.

What this means for people with MS

The listing offers a way to explore study participation, not evidence that the drug works or approved treatment access. The relevant centre must confirm current recruitment and eligibility. REMASTER has no posted results, and Greek commercial availability or reimbursement for this use is not established.

Greek centres and contacts

At its 25 Oct 2026 check, the EU trial register named Greek centres and reported recruiting for Greece as a country. ClinicalTrials.gov and Novartis show Greek location rows under generic site labels; these rows have not been matched one-to-one to the named EU centres. Contact a centre to confirm current enrolment, eligibility and contact details; the country status does not confirm that every listed centre is enrolling.

Chaidari

University General Hospital Attikon General Hospital Of West Attica H Agia Varvara

Second Department of Neurology

Address
Rimini 1, 124 61, Greece
Study contact
Prof. Sotirios Giannopoulos

EU trial register ↗ · Source checked:

Larissa

General University Hospital Of Larissa

Neurology Clinic

Address
P. O. Box 1425, 411 10, Greece
Study contact
Dr. Efthimios Dardiotis

Postal box; this is not a visit address.

EU trial register ↗ · Source checked:

Thessaloniki

St. Luke's Hospital S.A.

Neurology Department

Address
Harilaou Trikoupi Str. 3, 552 36, Greece
Study contact
Dr. Konstantinos Notas

The study record gives number 3; the clinic FAQ gives number 1. Confirm the address with the centre. Clinic FAQ ↗

EU trial register ↗ · Source checked:

Cholargos

Metropolitan General Hospital Healthcare Facilities Operation And Management Single Member S.A.

Neurology Department

Address
Leoforos Mesogeion 264, 155 62, Greece
Study contact
Dr. Dimitrios Papadopoulos

EU trial register ↗ · Source checked:

About the approach studied in this programme: REMASTER (remibrutinib)

Remibrutinib inhibits Bruton's tyrosine kinase (BTK), a protein involved in immune-cell signalling. The trial tests its clinical effect and safety in secondary progressive MS; a proposed mechanism does not prove benefit.

Approach source: Novartis — remibrutinib mechanism; REMODEL results concern relapsing MS ↗

What kind of evidence exists?
EU clinical trial register country status and recruitment start date
How reliable is this source?
Official EU country and site listing; status can change and provides no results on whether the drug helps or is safe

Related study or programme: REMASTER (remibrutinib) →

Source: EU Clinical Trials Information System — official EU clinical-trial registry ↗
Research event/source date
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Last substantive MyelinWatch update

Related substantive developments

Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in Greece; not a result

Phase 3 extension study authorised in Greece; recruitment not yet started

Frexalimab: Greece authorises the long-term Phase 3 extension study

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Greece authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 2 November 2026. Denmark, Portugal and Poland authorised it on the same day, after Belgium (30 October 2026) and Austria (1 November 2026); all six countries are listed as authorised with recruitment pending. The record plans 17 participants in Greece and lists four Greek hospitals: AHEPA University General Hospital of Thessaloniki, the University General Hospital of Ioannina, the General University Hospital of Larissa and the 401 General Military Hospital of Athens. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody, in people with multiple sclerosis (MS). It is open only to people who complete earlier frexalimab studies on the study drug, such as the Phase 3 studies FREXALT and FREVIVA. The estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed in Greece; it does not mean that it has started at any Greek hospital, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension, so it is not a way for other people with MS in Greece to receive frexalimab. Frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsRegistered study in peopleStudy authorised in two EU countries; not a result

Phase 3 extension study authorised in two EU countries; recruitment not yet started

Frexalimab: long-term Phase 3 extension study authorised in Belgium and Austria

Organisation: Sanofi · France

The EU Clinical Trials Information System (CTIS) shows that Belgium authorised Sanofi's Phase 3 extension study LTS18002 (2026-525688-41-00) on 30 October 2026 and Austria on 1 November 2026. The study will look at the long-term safety and tolerability of frexalimab, an experimental antibody given into a vein or under the skin, in people with multiple sclerosis (MS). It is open only to people with relapsing MS or non-relapsing secondary progressive MS who complete earlier frexalimab studies on the study drug, including the Phase 3 studies FREXALT and FREVIVA. It plans 1,710 participants in total. Both countries are listed as authorised with recruitment pending; the estimated EU recruitment start is 15 February 2027.

Published by MyelinWatch:

What this means for people with MS

Authorisation means the study may proceed; it does not mean that it has started, that anyone has received treatment in it, or that frexalimab works. No Phase 3 results are available yet. People who are not already in a frexalimab study cannot join this extension. Greece authorised the study later, on 2 November 2026 (see the separate update); frexalimab is not an available treatment in Greece.

Read the update →Source: EU Clinical Trials Information System (CTIS), European Medicines Agency — official CTIS record ↗Source: ClinicalTrials.gov — FREXALT (NCT06141473), Phase 3, ongoing, not accepting new participants ↗ Source: ClinicalTrials.gov — FREVIVA (NCT06141486), Phase 3, ongoing, not accepting new participants ↗
Research event/source date:
Emerging treatmentsResults from peopleSubgroup finding: significant in Hispanic or Latino participants, not significant in Black participants

Post hoc analysis of two completed Phase 3 trials in relapsing MS

OPERA trials: post hoc look at disability worsening in Black and Hispanic or Latino participants

Organisation: Keck School of Medicine, University of Southern California, with Genentech and Roche · United States

Researchers led by the University of Southern California, with authors from Genentech, Roche and other US centres, re-analysed the OPERA I and II trials, which compared ocrelizumab with interferon beta-1a for two years in relapsing multiple sclerosis (MS). In the interferon group, non-Hispanic Black and Hispanic or Latino participants had a higher risk of disability worsening confirmed after 24 weeks, measured with a combined (composite) disability measure, than non-Hispanic White participants (hazard ratio 3.0 and 2.3). Non-Hispanic Black and Hispanic or Latino participants also had more CD19-positive B cells at the start. In 1,138 participants who consented to genetic analysis, higher African or Americas genetic ancestry was also linked to higher risk. Ocrelizumab lowered B cells in all groups. Compared with interferon, it lowered the risk of this composite disability worsening in Hispanic or Latino participants (hazard ratio 0.38; 95% confidence interval 0.20–0.72). In the 65 Black participants the estimate also pointed to lower risk (hazard ratio 0.41), but the 95% confidence interval of 0.13–1.29 includes no difference, so the result is not statistically significant.

Published by MyelinWatch:

What this means for people with MS

This is not a new treatment or a new approval: ocrelizumab is already an approved MS treatment. The analysis was done after the trials ended, in small subgroups (only 65 Black participants), using self-reported race and ethnicity; it cannot show why risk differed and does not change treatment guidance. The authors conclude that ocrelizumab reduced risk regardless of race or ethnicity, but for Black participants the study alone does not establish this. It does not establish availability or reimbursement in Greece or support changing an individual treatment without a neurologist.

Read the update →Source: Multiple Sclerosis Journal (SAGE) — peer-reviewed primary article ↗Source: Multiple Sclerosis Journal — DOI 10.1177/13524585261496124 ↗ Source: ClinicalTrials.gov — OPERA I (NCT01247324), completed with posted results ↗ Source: ClinicalTrials.gov — OPERA II (NCT01412333), completed with posted results ↗