A Phase 3, Open-label, Crossover Study to Evaluate Self-administration of Rozanolixizumab by Study Participants With Generalized Myasthenia Gravis (gMG)

Last updated: November 3, 2025
Sponsor: UCB Biopharma SRL
Overall Status: Completed

Phase

3

Condition

Polymyositis (Inflammatory Muscle Disease)

Myasthenia Gravis Generalised

Neuropathy

Treatment

Rozanolixizumab

Clinical Study ID

NCT05681715
MG0020
2022-003870-21
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to evaluate the ability of study participants with generalized Myasthenia Gravis (gMG) to successfully self-administer rozanolixizumab after training in the self-administration technique using the syringe driver and manual push methods.

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

Total Participants: 62
Treatment Group(s): 1
Primary Treatment: Rozanolixizumab
Phase: 3
Study Start date:
April 17, 2023
Estimated Completion Date:
April 23, 2024

Connect with a study center

  • Mg0020 50560

    Edmonton,
    Canada

    Site Not Available

  • Mg0020 50560

    Edmonton 5946768,
    Canada

    Site Not Available

  • Mg0020 50069

    Toronto,
    Canada

    Site Not Available

  • Mg0020 50069

    Toronto 6167865,
    Canada

    Site Not Available

  • Mg0020 20161

    Tbilisi,
    Georgia

    Site Not Available

  • Mg0020 20163

    Tbilisi,
    Georgia

    Active - Recruiting

  • Mg0020 20165

    Tbilisi,
    Georgia

    Site Not Available

  • Mg0020 20305

    Tbilisi,
    Georgia

    Site Not Available

  • Mg0020 20161

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Mg0020 20165

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Mg0020 20305

    Tbilisi 611717,
    Georgia

    Site Not Available

  • Mg0020 40135

    Gummersbach,
    Germany

    Site Not Available

  • Mg0020 40140

    Göttingen,
    Germany

    Site Not Available

  • Mg0020 40140

    Göttingen 2918632,
    Germany

    Site Not Available

  • Mg0020 40177

    Münster,
    Germany

    Site Not Available

  • Mg0020 40177

    Münster 2867543,
    Germany

    Site Not Available

  • Mg0020 40144

    Milan 6951411,
    Italy

    Site Not Available

  • Mg0020 40144

    Milano,
    Italy

    Site Not Available

  • Mg0020 40146

    Pavia,
    Italy

    Site Not Available

  • Mg0020 40146

    Pavia 3171366,
    Italy

    Site Not Available

  • Mg0020 40150

    Roma,
    Italy

    Site Not Available

  • Mg0020 40150

    Roma 8957247,
    Italy

    Site Not Available

  • Mg0020 20068

    Chiba 2113015,
    Japan

    Site Not Available

  • Mg0020 20068

    Chiba-shi,
    Japan

    Site Not Available

  • Mg0020 20078

    Hanamaki-shi,
    Japan

    Site Not Available

  • Mg0020 20077

    Sendai,
    Japan

    Site Not Available

  • Mg0020 20077

    Sendai 2111149,
    Japan

    Site Not Available

  • Mg0020 20076

    Shinjuku-ku,
    Japan

    Site Not Available

  • Mg0020 40155

    Gdansk,
    Poland

    Site Not Available

  • Mg0020 40155

    Gdansk 3099434,
    Poland

    Site Not Available

  • Mg0020 40727

    Lodz,
    Poland

    Site Not Available

  • Mg0020 40727

    Lodz 3093133,
    Poland

    Site Not Available

  • Mg0020 40153

    Poznan,
    Poland

    Site Not Available

  • Mg0020 40153

    Poznan 3088171,
    Poland

    Site Not Available

  • Mg0020 40729

    NIS,
    Serbia

    Site Not Available

  • Mg0020 40729

    Niš 787657,
    Serbia

    Site Not Available

  • Mg0020 40160

    Barcelona,
    Spain

    Site Not Available

  • Mg0020 40267

    Barcelona,
    Spain

    Site Not Available

  • Mg0020 40160

    Barcelona 3128760,
    Spain

    Site Not Available

  • Mg0020 40267

    Barcelona 3128760,
    Spain

    Site Not Available

  • Mg0020 40308

    San Sebastián de Los Reyes,
    Spain

    Site Not Available

  • Mg0020 40308

    San Sebastián de los Reyes 3110040,
    Spain

    Site Not Available

  • Mg0020 40168

    Nottingham,
    United Kingdom

    Site Not Available

  • Mg0020 40168

    Nottingham 2641170,
    United Kingdom

    Site Not Available

  • Mg0020 40163

    Oxford,
    United Kingdom

    Site Not Available

  • Mg0020 40163

    Oxford 2640729,
    United Kingdom

    Site Not Available

  • Mg0020 50092

    Orange, California 92868
    United States

    Site Not Available

  • Mg0020 50099

    San Francisco, California 94143
    United States

    Site Not Available

  • Mg0020 50092

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • Mg0020 50099

    San Francisco 5391959, California 5332921 94143
    United States

    Site Not Available

  • Mg0020 50561

    Lexington, Kentucky 40536-0284
    United States

    Site Not Available

  • Mg0020 50561

    Lexington 4297983, Kentucky 6254925 40536-0284
    United States

    Site Not Available

  • Mg0020 50090

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

  • Mg0020 50090

    Winston-Salem 4499612, North Carolina 4482348 27157
    United States

    Site Not Available

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