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NCT07465289Not yet recruitingPhase 3

A study to learn how rozanolixizumab is safe and works in adults with ocular myasthenia gravis

A Phase 3, open-label extension study to evaluate the long-term safety and efficacy of rozanolixizumab in adult participants with ocular myasthenia gravis

Source: EU CTIS (euclinicaltrials.eu) · Last updated 4 Nov 2026

Brief summary (registry, in English)

To assess the safety and tolerability of rozanolixizumab in adult study participants with ocular Myasthenia Gravis

Status (registry)
Not yet recruiting
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
46 (estimated)
First submitted
29 Apr 2026
Start date
30 Sept 2026
Lead sponsor
UCB Biopharma
NCT number
NCT07465289
EU CT number
2025-524757-14-00

What you commit to

  • Study type: Interventional · Phase 3
  • Planned participants: 46
  • 49 sites in 7 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study, not your situation.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participant has a clinically relevant active infection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before study entry.
  • Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies
  • Participant has planned use of prohibited medications

Other

  • Participant meets any of the withdrawal criteria defined in MG0038.
  • Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab.

Who the study is looking for

  • Participant must be a minimum of 18 years of age inclusive at the time of signing the ICF.
  • Participant must have received at least 1 dose of IMP (rozanolixizumab or placebo) in MG0038.
  • Participant for whom the investigator considers a favorable benefit/risk for participation.
  • Participant who, alone or with assistance of the caregiver, is considered reliable and capable of adhering to the protocol visit schedule or medication intake according to the judgement of the investigator.
  • Male or female − A female participant is eligible to participate if she is not, not breastfeeding (including pumping breastmilk to feed a child), and at least 1 of the following conditions applies: ◦ Not a WOCBP ◦ OR ◦ A WOCBP who agrees to follow the contraceptive guidance for the entire study period.
  • Capable of giving signed informed consent, which includes compliance with the requirements and restrictions listed in the ICF and in the protocol.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (49)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH
Coordinator of this site? Confirm its status
BochumGermanyNot yet recruiting
Universitaetsklinikum Essen (AoR)
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EssenGermanyNot yet recruiting
Universitaetsmedizin Goettingen
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GoettingenGermanyNot yet recruiting
Universitaetsklinikum Jena KöR
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JenaGermanyNot yet recruiting
Universitaet Leipzig
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LeipzigGermanyNot yet recruiting
Immanuel Klinik Ruedersdorf
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RüdersdorfGermanyNot yet recruiting
Universitaetsklinikum Wuerzburg AöR
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WuerzburgGermanyNot yet recruiting
Hospital General Universitario Dr. Balmis
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AlicanteSpainNot yet recruiting
Hospital Universitari Vall d'Hebron
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BarcelonaSpainNot yet recruiting
Hospital Clinic de Barcelona
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BarcelonaSpainNot yet recruiting
Hospital de la Santa Creu i Sant Pau
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BarcelonaSpainNot yet recruiting
Hospital Universitario Basurto
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BilbaoSpainNot yet recruiting
Bellvitge University Hospital
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L'hospitalet De LlobregatSpainNot yet recruiting
Hospital Universitario Ramón y Cajal
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MadridSpainNot yet recruiting
Hospital Universitario Regional de Málaga
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MálagaSpainNot yet recruiting
University Clinical Hospital Virgen De La Arrixaca
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MurciaSpainNot yet recruiting
Hospital Universitario Infanta Sofia
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San Sebastián de los ReyesSpainNot yet recruiting
Hospital Universitario Virgen De La Macarena
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SevillaSpainNot yet recruiting
Centre Hospitalier Universitaire de Dijon
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DijonFranceNot yet recruiting
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceNot yet recruiting
Centre Hospitalier Regional De Marseille
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MarseilleFranceNot yet recruiting
Centre Hospitalier Universitaire De Montpellier
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Montpellier Cedex 5FranceNot yet recruiting
Centre Hospitalier Universitaire de Nantes
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NantesFranceNot yet recruiting
Centre Hospitalier Universitaire de Nice
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NiceFranceNot yet recruiting
Centre Hospitalier National d'Ophtalmologie des Quize-Vingts
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ParisFranceNot yet recruiting
Fondation A. de Rothschild
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ParisFranceNot yet recruiting
Centre Hospitalier Universitaire de Toulouse
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ToulouseFranceNot yet recruiting
Eginitio Hospital
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AthensGreeceNot yet recruiting
University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA"
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ChaïdáriGreeceNot yet recruiting
General University Hospital of Larissa
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LarissaGreeceNot yet recruiting
General University Hospital Of Patras
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PatrasGreeceNot yet recruiting
Semmelweis University
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Budapest VIIIHungaryCompleted
University of Pecs
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PécsHungaryCompleted
University of Szeged
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SzegedHungaryCompleted
Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII
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BergamoItalyNot yet recruiting
Azienda Ospedaliero-Universitaria Careggi
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FlorenceItalyNot yet recruiting
Azienda Ospedaliera Universitaria Gaetano Martino Messina
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MessinaItalyNot yet recruiting
IRCCS Foundation Istituto Neurologico Carlo Besta
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MilanItalyNot yet recruiting
Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli
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NaplesItalyNot yet recruiting
Fondazione Istituto Neurologico Nazionale Casimiro Mondino
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PaviaItalyNot yet recruiting
Azienda Ospedaliero Universitaria Pisana
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PisaItalyNot yet recruiting
Krakowska Akademia Neurologii Sp. z o.o.
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CracowPolandNot yet recruiting
Neurocor Banaszkiewicz Tomaszewski Lekarze sp.p.
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CracowPolandNot yet recruiting
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie
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CracowPolandNot yet recruiting
Neurologia Śląska Centrum Medyczne
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KatowicePolandNot yet recruiting
Centrum Medyczne Hope Clinic Sebastian Szklener
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LublinPolandNot yet recruiting
Clinical Research Center Sp z o o Medic R Sp k
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PoznanPolandNot yet recruiting
NeuroProtect Sp. z o.o.
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WarsawPolandNot yet recruiting
Clinhouse Sp. z o.o.
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ZabrzePolandNot yet recruiting

This page is information, not medical advice. Discuss any trial with your doctor.