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โ† Trials
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A Study to Evaluate The Long-Term Safety And Efficacy of Rozanolixizumab in Adult Participants With Ocular Myasthenia Gravis

RecruitingPhase 3Ages 18 Years - anyAllUCB Biopharma SRL
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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
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What it tests

  • Rozanolixizumab
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Where

7 sites
Mg0039 10103
Columbus, United States
Mg0039 31901
Beijing, China
Mg0039 31907
Nanchang, China
Mg0039 31902
Suzhou, China
Mg0039 31802
Kobe, Japan
Mg0039 20604
Barcelona, Spain
Mg0039 20611
Madrid, Spain
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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