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

UCB

Status and phase: Completed; Phase 3

Conditions: Generalized Myasthenia Gravis

Treatments: Drug: Rozanolixizumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT05681715

MG0020

2022-003870-21 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 62 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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62 participants in 2 patient groups

Rozanolixizumab Sequence 1: Syringe Driver - Manual Push

Experimental group

Description:

Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.

Treatment:

Drug: Rozanolixizumab

Rozanolixizumab Sequence 2: Manual Push - Syringe Driver

Experimental group

Description:

Study participants will receive predefined weekly doses of rozanolixizumab for 18 weeks.

Treatment:

Drug: Rozanolixizumab