Self-administration of rozanolixizumab via manual push and infusion pump methods in patients with generalised myasthenia gravis: a randomised, phase 3, open-label, crossover study.

ABSTRACT:

Background

The phase 3, open-label, randomised, crossover MG0020 study investigated rozanolixizumab self-administration, efficacy, and safety in patients with generalised myasthenia gravis (gMG) using infusion pump and manual push methods.

Methods

Adults with gMG received once-weekly rozanolixizumab for 18 weeks, comprising a 6-week Training Period and two 6-week Self-Administration Periods where patients were randomised 1:1 to Sequence 1 (infusion pump then manual push) or Sequence 2 (manual push then infusion pump). The primary endpoint was successful rozanolixizumab self-administration (choosing correct infusion site, administering subcutaneously, delivering intended dose), evaluated by a healthcare professional (HCP) at weeks 12 and 18. Secondary endpoints included treat

SUBMITTER: Bril V 

PROVIDER: S-EPMC12515207 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature