Ad Scientiam, a French MedTech company specialised in the development of digital biomarkers, has announced 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.
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.
— Lissandra Klaeylé, Head of Clinical Operations, Ad Scientiam
The HARMONY 360 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 is to explore the feasibility of using MyoSense 360 to detect changes in disease trajectory in adults with generalized Myasthenia Gravis, under real-life, unsupervised conditions.
The investigational version of MyoSense 360 combines three distinct components into a single monitoring platform:
– Continuous passive monitoring utilizing a wearable device (ActiGraph LEAP), to continuously 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 measures such as MG-ADL and MG-QoL15r, as well as fatigue (NeuroQoL), infection tracking, and additional questionnaires administered using 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.
