Clinical Trial

Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG

Study acronym: BioDigit MG-03
Not Yet Recruiting
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Summary
Evaluate the feasibility of using digital health technologies to monitor disease symptoms over time in individuals with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo®. Study subjects will be screened and enrolled at Massachusetts General Brigham Hospital to participate in this 16 week observational study. Study subjects will be asked to wear multiple wearable sensors to monitor their physical activity and PPG during daily activities. Participants will also complete speech, video, and ePRO and eCOA digital assessments at home and during study visits. The primary objective of this observational clinical study is to remotely evaluate MG-specific outcomes using digital health technologies in individuals with gMG during two treatment cycles with VYVGART® or VYVGART Hytrulo®.
Trial Details
NCT Number NCT07226830
Lead Sponsor BioSensics
Collaborators: Massachusetts General Hospital
Conditions Myasthenia Gravis Generalized
Enrollment 25 participants
Start Date 2026-01-15
Primary Completion 2028-01-31 (estimated)
Study Completion 2028-03-31 (estimated)
Updated on ClinicalTrials.gov 2025-11-12