Batoclimab as induction and maintenance therapy in patients with myasthenia gravis: rationale and study design of a phase 3 clinical trial.

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.

Subcutaneous batoclimab in generalized myasthenia gravis: Results from a Phase 2a trial with an open-label extension.

Objectives: To assess the safety, tolerability, and key pharmacodynamic effects of subcutaneous batoclimab, a fully human anti-neonatal Fc receptor monoclonal antibody, in patients with generalized myasthenia gravis and anti-acetylcholine receptor antibodies.

Methods: A Phase 2a, proof-of-concept, randomized, double-blind, placebo-controlled trial is described. Eligible patients were randomized (1:1:1) to receive once-weekly subcutaneous injections of batoclimab 340 mg, batoclimab 680 mg, or matching placebo for 6 weeks.

Insights to Improve Dietary Guidelines for Americans Communication and Policy.

This study aims to tease out why the Dietary Guidelines for Americans (DGA) have largely failed to support positive attitudinal and behavioral dietary change in the U.S. over the past decade.

Proof-of-concept and Randomized, Placebo-controlled Trials of an FcRn Inhibitor, Batoclimab, for Thyroid Eye Disease.

Context: Inhibition of the neonatal fragment crystallizable receptor (FcRn) reduces pathogenic thyrotropin receptor antibodies (TSH-R-Ab) that drive pathology in thyroid eye disease (TED).

Objective: We report the first clinical studies of an FcRn inhibitor, batoclimab, in TED.

Design: Proof-of-concept (POC) and randomized, double-blind placebo-controlled trials.

Refining the online health information searcher typology: Applying the patient health engagement model.

Background: Despite numerous quantitative findings on online health information seeking, little is known about the process of online health information seeking itself.

Objectives: The study aimed to learn about how adults search for health information online, whether Macias et al.'s Online Health Searcher Typology applies to a broader, non-university sample, and to better identify and understand online health searchers by employing the Patient Health Engagement (PHE) model.