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
- Diseases
- Myasthenia gravis
- 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
Sites (49)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Berufsgenossenschaftliches Universitaetsklinikum Bergmannsheil gGmbH Coordinator of this site? Confirm its status | Bochum | Germany | Not yet recruiting |
| Universitaetsklinikum Essen (AoR) Coordinator of this site? Confirm its status | Essen | Germany | Not yet recruiting |
| Universitaetsmedizin Goettingen Coordinator of this site? Confirm its status | Goettingen | Germany | Not yet recruiting |
| Universitaetsklinikum Jena KöR Coordinator of this site? Confirm its status | Jena | Germany | Not yet recruiting |
| Universitaet Leipzig Coordinator of this site? Confirm its status | Leipzig | Germany | Not yet recruiting |
| Immanuel Klinik Ruedersdorf Coordinator of this site? Confirm its status | Rüdersdorf | Germany | Not yet recruiting |
| Universitaetsklinikum Wuerzburg AöR Coordinator of this site? Confirm its status | Wuerzburg | Germany | Not yet recruiting |
| Hospital General Universitario Dr. Balmis Coordinator of this site? Confirm its status | Alicante | Spain | Not yet recruiting |
| Hospital Universitari Vall d'Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital de la Santa Creu i Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Not yet recruiting |
| Hospital Universitario Basurto Coordinator of this site? Confirm its status | Bilbao | Spain | Not yet recruiting |
| Bellvitge University Hospital Coordinator of this site? Confirm its status | L'hospitalet De Llobregat | Spain | Not yet recruiting |
| Hospital Universitario Ramón y Cajal Coordinator of this site? Confirm its status | Madrid | Spain | Not yet recruiting |
| Hospital Universitario Regional de Málaga Coordinator of this site? Confirm its status | Málaga | Spain | Not yet recruiting |
| University Clinical Hospital Virgen De La Arrixaca Coordinator of this site? Confirm its status | Murcia | Spain | Not yet recruiting |
| Hospital Universitario Infanta Sofia Coordinator of this site? Confirm its status | San Sebastián de los Reyes | Spain | Not yet recruiting |
| Hospital Universitario Virgen De La Macarena Coordinator of this site? Confirm its status | Sevilla | Spain | Not yet recruiting |
| Centre Hospitalier Universitaire de Dijon Coordinator of this site? Confirm its status | Dijon | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Not yet recruiting |
| Centre Hospitalier Regional De Marseille Coordinator of this site? Confirm its status | Marseille | France | Not yet recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Nantes | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Not yet recruiting |
| Centre Hospitalier National d'Ophtalmologie des Quize-Vingts Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Fondation A. de Rothschild Coordinator of this site? Confirm its status | Paris | France | Not yet recruiting |
| Centre Hospitalier Universitaire de Toulouse Coordinator of this site? Confirm its status | Toulouse | France | Not yet recruiting |
| Eginitio Hospital Coordinator of this site? Confirm its status | Athens | Greece | Not yet recruiting |
| University General Hospital "ATTIKON" - General Hospital of West Attica "H AGIA VARVARA" Coordinator of this site? Confirm its status | Chaïdári | Greece | Not yet recruiting |
| General University Hospital of Larissa Coordinator of this site? Confirm its status | Larissa | Greece | Not yet recruiting |
| General University Hospital Of Patras Coordinator of this site? Confirm its status | Patras | Greece | Not yet recruiting |
| Semmelweis University Coordinator of this site? Confirm its status | Budapest VIII | Hungary | Completed |
| University of Pecs Coordinator of this site? Confirm its status | Pécs | Hungary | Completed |
| University of Szeged Coordinator of this site? Confirm its status | Szeged | Hungary | Completed |
| Azienda Socio Sanitaria Territoriale Papa Giovanni XXIII Coordinator of this site? Confirm its status | Bergamo | Italy | Not yet recruiting |
| Azienda Ospedaliero-Universitaria Careggi Coordinator of this site? Confirm its status | Florence | Italy | Not yet recruiting |
| Azienda Ospedaliera Universitaria Gaetano Martino Messina Coordinator of this site? Confirm its status | Messina | Italy | Not yet recruiting |
| IRCCS Foundation Istituto Neurologico Carlo Besta Coordinator of this site? Confirm its status | Milan | Italy | Not yet recruiting |
| Azienda Ospedaliera di Rilievo Nazionale Antonio Cardarelli Coordinator of this site? Confirm its status | Naples | Italy | Not yet recruiting |
| Fondazione Istituto Neurologico Nazionale Casimiro Mondino Coordinator of this site? Confirm its status | Pavia | Italy | Not yet recruiting |
| Azienda Ospedaliero Universitaria Pisana Coordinator of this site? Confirm its status | Pisa | Italy | Not yet recruiting |
| Krakowska Akademia Neurologii Sp. z o.o. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Neurocor Banaszkiewicz Tomaszewski Lekarze sp.p. Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Coordinator of this site? Confirm its status | Cracow | Poland | Not yet recruiting |
| Neurologia Śląska Centrum Medyczne Coordinator of this site? Confirm its status | Katowice | Poland | Not yet recruiting |
| Centrum Medyczne Hope Clinic Sebastian Szklener Coordinator of this site? Confirm its status | Lublin | Poland | Not yet recruiting |
| Clinical Research Center Sp z o o Medic R Sp k Coordinator of this site? Confirm its status | Poznan | Poland | Not yet recruiting |
| NeuroProtect Sp. z o.o. Coordinator of this site? Confirm its status | Warsaw | Poland | Not yet recruiting |
| Clinhouse Sp. z o.o. Coordinator of this site? Confirm its status | Zabrze | Poland | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.