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

Completed · Phase 3

Conditions studied: Generalized Myasthenia Gravis

In brief

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.

Key facts

Study ID

NCT05681715

Run by

UCB Biopharma SRL

People needed

62

Starts

2023-04-17

Expected to finish

2024-04-23

Last updated by the study team

2025-11-06

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Study participant must have a documented diagnosis of generalized Myasthenia Gravis (gMG)
• Study participant is willing to perform and capable of performing home self-administration
• Study participant is considered by the investigator for additional rozanolixizumab treatment with the posology proposed in this study.
• Body weight ≥35 kg
• Study participants may be male or female

You may not qualify if…

• 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 both polysorbate 80 and L-proline are constituents of the rozanolixizumab formulation
• Study participant with a known tuberculosis (TB) infection, at high risk of acquiring TB infection, or latent tuberculosis infection (LTBI), or current or history of nontuberculous mycobacterial infection (NTMBI)
• Study participant has a clinically relevant active infection or a history of serious infection (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 and met any mandatory withdrawal criteria (unless the reason is directly related to MG0020 participation) or mandatory study drug discontinuation criteria.
• Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette-Guérin (BCG) vaccine within 1 year before starting treatment; or intends to have a live vaccination during the course of the study or within 8 weeks following the last dose of rozanolixizumab
• Study participant with severe (defined as Grade 3 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) scale) weakness affecting oropharyngeal or respiratory muscles, or who has myasthenic crisis or impending crisis

Where it is running

• Mg0020 20305 — Tbilisi, Georgia
• Mg0020 40140 — Göttingen, Germany
• Mg0020 40177 — Münster, Germany
• Mg0020 40144 — Milan, Italy
• Mg0020 40146 — Pavia, Italy
• Mg0020 40150 — Roma, Italy
• Mg0020 20068 — Chiba, Japan
• Mg0020 20078 — Hanamaki-shi, Japan
• Mg0020 20077 — Sendai, Japan
• Mg0020 20076 — Shinjuku-ku, Japan
• Mg0020 40155 — Gdansk, Poland
• Mg0020 40727 — Lodz, Poland
• Mg0020 40153 — Poznan, Poland
• Mg0020 40729 — Niš, Serbia
• Mg0020 40160 — Barcelona, Spain
• Mg0020 40267 — Barcelona, Spain
• Mg0020 40308 — San Sebastián de los Reyes, Spain
• Mg0020 40168 — Nottingham, United Kingdom
• Mg0020 40163 — Oxford, United Kingdom
• Mg0020 50092 — Orange, California, United States
• Mg0020 50099 — San Francisco, California, United States
• Mg0020 50561 — Lexington, Kentucky, United States
• Mg0020 50090 — Winston-Salem, North Carolina, United States
• Mg0020 50560 — Edmonton, Canada
• Mg0020 50069 — Toronto, Canada

Full record on ClinicalTrials.gov

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