A Phase 3, open-label, crossover study to evaluate self-administration of rozanolixizumab by study participants with generalized Myasthenia Gravis(gMG).

JRCT ID: jRCT2021230009

Registered date:13/06/2023

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Generalized Myasthenia Gravis
• Date of first enrollment: 01/06/2023
• Target sample size: 4
• Countries of recruitment: Canada,Japan,Georgia,Japan,Germany,Japan,Italy,Japan,Poland,Japan,Serbia,Japan,Spain,Japan,United Kingdom,Japan,United States,Japan
• Study type: Interventional
• Intervention(s): Rozanolixizumab self-administration via Syringe Driver or Manual Push.

Outcome(s)

Primary Outcome

- Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respectively) during the Selfadministration Period at Visit 13
- Successful self-administration of rozanolixizumab (with correct use of syringe driver and manual push, respecively) during the Selfadministration Period at Visit 19

Secondary Outcome

- Occurrence of Treatment-Emergent Adverse Events (TEAEs) after syringe driver or manual push self-administration from Visit 2 up to the End of Study Visit
- Occurrence of local site reactions up to 24 hours after each administration during the Training Period and Self-administration Periods
- Occurrence of medication errors associated with adverse reactions during the 2 Self-administration Periods of the study

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include 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 for additional rozanolixizumab treatment with the posology proposed in this study
- Body weight >=35 kg
- Study participants may be male or female

Exclude criteria

- Study participant has a known hypersensitivity to any components of the study medication or other anti-neonatal Fc receptor (FcRn) medications
- 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 or mandatory study drug discontinuation criteria
- Study participant has received a live vaccination within 4 weeks before starting treatment, or a Bacillus Calmette Guerin (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

Related Information

• Primary Sponsor: Kaori Ikeda
• Secondary ID(s): 2022-003870-21,NCT05681715