Phase
Condition
Polymyositis (Inflammatory Muscle Disease)
Myasthenia Gravis Generalised
Neuropathy
Treatment
Rozanolixizumab
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
Study participant is willing to perform and capable of performing homeself-administration
Study participant is considered by the investigator for additional rozanolixizumabtreatment with the posology proposed in this study.
Body weight ≥35 kg
Study participants may be male or female
Exclusion
Exclusion Criteria:
Study participant has a known hypersensitivity to other anti-Fc receptor (FcRn)medications, to any components of the study medication, to any of the excipients (including polysorbate 80), or has a known history of hyperprolinemia, since bothpolysorbate 80 and L-proline are constituents of the rozanolixizumab formulation
Study participant with a known tuberculosis (TB) infection, at high risk ofacquiring TB infection, or latent tuberculosis infection (LTBI), or current orhistory of nontuberculous mycobacterial infection (NTMBI)
Study participant has a clinically relevant active infection or a history of seriousinfection (resulting in hospitalization or requiring IV antibiotic treatment) within 6 weeks before the Baseline Visit
The study participant previously participated in any rozanolixizumab MG study andmet any mandatory withdrawal criteria (unless the reason is directly related toMG0020 participation) or mandatory study drug discontinuation criteria.
Study participant has received a live vaccination within 4 weeks before startingtreatment, or a Bacillus Calmette-Guérin (BCG) vaccine within 1 year before startingtreatment; or intends to have a live vaccination during the course of the study orwithin 8 weeks following the last dose of rozanolixizumab
Study participant with severe (defined as Grade 3 on the Myasthenia GravisActivities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal orrespiratory muscles, or who has myasthenic crisis or impending crisis
Study Design
Connect with a study center
Mg0020 50560
Edmonton,
CanadaSite Not Available
Mg0020 50560
Edmonton 5946768,
CanadaSite Not Available
Mg0020 50069
Toronto,
CanadaSite Not Available
Mg0020 50069
Toronto 6167865,
CanadaSite Not Available
Mg0020 20161
Tbilisi,
GeorgiaSite Not Available
Mg0020 20163
Tbilisi,
GeorgiaActive - Recruiting
Mg0020 20165
Tbilisi,
GeorgiaSite Not Available
Mg0020 20305
Tbilisi,
GeorgiaSite Not Available
Mg0020 20161
Tbilisi 611717,
GeorgiaSite Not Available
Mg0020 20165
Tbilisi 611717,
GeorgiaSite Not Available
Mg0020 20305
Tbilisi 611717,
GeorgiaSite Not Available
Mg0020 40135
Gummersbach,
GermanySite Not Available
Mg0020 40140
Göttingen,
GermanySite Not Available
Mg0020 40140
Göttingen 2918632,
GermanySite Not Available
Mg0020 40177
Münster,
GermanySite Not Available
Mg0020 40177
Münster 2867543,
GermanySite Not Available
Mg0020 40144
Milan 6951411,
ItalySite Not Available
Mg0020 40144
Milano,
ItalySite Not Available
Mg0020 40146
Pavia,
ItalySite Not Available
Mg0020 40146
Pavia 3171366,
ItalySite Not Available
Mg0020 40150
Roma,
ItalySite Not Available
Mg0020 40150
Roma 8957247,
ItalySite Not Available
Mg0020 20068
Chiba 2113015,
JapanSite Not Available
Mg0020 20068
Chiba-shi,
JapanSite Not Available
Mg0020 20078
Hanamaki-shi,
JapanSite Not Available
Mg0020 20077
Sendai,
JapanSite Not Available
Mg0020 20077
Sendai 2111149,
JapanSite Not Available
Mg0020 20076
Shinjuku-ku,
JapanSite Not Available
Mg0020 40155
Gdansk,
PolandSite Not Available
Mg0020 40155
Gdansk 3099434,
PolandSite Not Available
Mg0020 40727
Lodz,
PolandSite Not Available
Mg0020 40727
Lodz 3093133,
PolandSite Not Available
Mg0020 40153
Poznan,
PolandSite Not Available
Mg0020 40153
Poznan 3088171,
PolandSite Not Available
Mg0020 40729
NIS,
SerbiaSite Not Available
Mg0020 40729
Niš 787657,
SerbiaSite Not Available
Mg0020 40160
Barcelona,
SpainSite Not Available
Mg0020 40267
Barcelona,
SpainSite Not Available
Mg0020 40160
Barcelona 3128760,
SpainSite Not Available
Mg0020 40267
Barcelona 3128760,
SpainSite Not Available
Mg0020 40308
San Sebastián de Los Reyes,
SpainSite Not Available
Mg0020 40308
San Sebastián de los Reyes 3110040,
SpainSite Not Available
Mg0020 40168
Nottingham,
United KingdomSite Not Available
Mg0020 40168
Nottingham 2641170,
United KingdomSite Not Available
Mg0020 40163
Oxford,
United KingdomSite Not Available
Mg0020 40163
Oxford 2640729,
United KingdomSite Not Available
Mg0020 50092
Orange, California 92868
United StatesSite Not Available
Mg0020 50099
San Francisco, California 94143
United StatesSite Not Available
Mg0020 50092
Orange 5379513, California 5332921 92868
United StatesSite Not Available
Mg0020 50099
San Francisco 5391959, California 5332921 94143
United StatesSite Not Available
Mg0020 50561
Lexington, Kentucky 40536-0284
United StatesSite Not Available
Mg0020 50561
Lexington 4297983, Kentucky 6254925 40536-0284
United StatesSite Not Available
Mg0020 50090
Winston-Salem, North Carolina 27157
United StatesSite Not Available
Mg0020 50090
Winston-Salem 4499612, North Carolina 4482348 27157
United StatesSite Not Available

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