[Pubmed] Batoclimab as induction and maintenance therapy in patients with myasthenia gravis: rationale and study design
Posté : 25 janv. 2024 12:00
BMJ Neurol Open. 2024 Jan 10;6(1):e000536. doi: 10.1136/bmjno-2023-000536. eCollection 2024.
ABSTRACT
INTRODUCTION: Batoclimab, a fully human monoclonal antibody that inhibits the neonatal fragment crystallisable receptor, has shown promising phase 2 clinical trial results in patients with generalised myasthenia gravis (gMG).
METHODS AND ANALYSIS: In this phase 3, randomised, quadruple-blind, placebo-controlled study, adults with gMG will be randomised 1:1:1 to induction therapy with batoclimab 680 mg, batoclimab 340 mg, or placebo, administered once weekly (QW) for 12 weeks as a subcutaneous injection. The primary endpoint is the change from baseline to week 12 on the Myasthenia Gravis Activities of Daily Living (MG-ADL) score. Batoclimab-treated patients achieving a ≥2-point improvement from baseline on MG-ADL at week 10 or week 12 will be re-randomised to maintenance treatment with batoclimab 340 mg QW, batoclimab 340 mg every other week (Q2W), or placebo for 12 weeks; batoclimab-treated patients with a
Source: https://pubmed.ncbi.nlm.nih.gov/3826875 ... 2&v=2.18.0