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NCT07465289From ClinicalTrials.govRecruiting

A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants 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

  • Ocular Myasthenia Gravis

At a glance

Phase
Phase 3
Study type
Interventional
Sponsor
UCB Biopharma SRL
Enrolment target
100
Started
16 September 2026
Main results due
23 January 2031
Study sites
7
Registry updated
24 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
Inclusion Criteria:

* Participant must be a minimum of 18 years of age inclusive at the time of signing the informed consent form (ICF)
* Participant must have received at least 1 dose of investigational medicinal product (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 woman of childbearing potential (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

Exclusion Criteria:

* Participant meets any of the withdrawal criteria defined in MG0038
* Participant has a clinically relevant active infection (resulting in hospitalization or requiring intravenous (IV) antibiotic treatment) within 6 weeks before study entry.
* Participant intends to have a live vaccination during the study or within 8 weeks following the final dose of rozanolixizumab
* Participant has been administered with the prohibited immunosuppressive medications, biologics, or other therapies
* Participant has planned use of prohibited medications

What this study is about

In the sponsor’s own words, from the registry.

The purpose of the study is to assess the long-term safety and efficacy of rozanolixizumab in adult study participants with ocular myasthenia gravis.

Study sites(7)

  • Mg0039 10103

    Columbus, Ohio, United States

    Recruiting

  • Mg0039 31901

    Beijing, China

    Recruiting

  • Mg0039 31907

    Nanchang, China

    Recruiting

  • Mg0039 31902

    Suzhou, China

    Recruiting

  • Mg0039 31802

    Kobe, Japan

    Recruiting

  • Mg0039 20604

    Barcelona, Spain

    Recruiting

  • Mg0039 20611

    Madrid, Spain

    Recruiting

Showing 7 of 7 sites. 7 of the 7 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT07465289. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Mya | Trialion