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

• Status: Not yet recruiting
• Trial end date: 2024-04-29
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Biopharma SRL
• Treatments: Rozanolixizumab

Criteria

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 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-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