October 8, 2026
First Patient In for the HARMONY 360 study
We announce the enrollment of the First Patient In (FPI) in the HARMONY 360 study. Conducted in collaboration with Merck KGaA, Darmstadt, Germany, this prospective, multi-center, exploratory clinical study is designed to explore the feasibility of multimodal, remote digital monitoring in adults with generalized Myasthenia Gravis (gMG) using the investigational medical device MyoSense 360.
HARMONY 360: multimodal digital monitoring in generalized Myasthenia Gravis
The study will involve 100 adults with gMG across a specialized network of 20 investigating sites in five European countries (France, Germany, Italy, Spain and Denmark).
Over a 12-month longitudinal observation period, the study combines traditional, on-site clinical assessments such as the Quantitative Myasthenia Gravis (QMG) test with continuous collection of real-world digital measures. The objective: to explore the feasibility of using MyoSense 360 to detect changes in disease trajectory under real-life, unsupervised conditions.
The investigational version of MyoSense 360 combines three distinct components into a single monitoring platform:
Continuous passive monitoring using a wearable device (ActiGraph LEAP) to capture physical activity, sleep, heart rate and respiratory rate.
Active smartphone-based functional tests performed monthly (morning and evening), including assessments of ptosis, dysarthria, upper and lower limb weakness, and respiratory muscle weakness.
Electronic patient-reported outcomes (ePROs), including MG-ADL and MG-QoL15r, as well as fatigue (NeuroQoL), infection tracking and additional questionnaires administered on the participants' smartphone.
"Transitioning from study design to active patient enrollment in HARMONY 360 marks a pivotal operational shift. The decentralized, real-world data collection is live across European investigating sites, giving clinicians and patients continuous, objective metrics that point-in-time visits simply cannot capture," said Lissandra Klaeylé, Head of Clinical Operations at Ad Scientiam.
The insights obtained from the HARMONY 360 study will directly inform subsequent device optimization, algorithmic refinement and protocol scaling ahead of a future confirmatory study.