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NOT YET RECRUITING
NCT07226830

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

Sponsor: BioSensics

View on ClinicalTrials.gov

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®.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

OBSERVATIONAL

Enrollment

25

Start Date

2026-01-15

Completion Date

2028-03-31

Last Updated

2025-11-12

Healthy Volunteers

No

Locations (1)

Massachusetts General Hospital, Neuromuscular Diagnostic Center

Boston, Massachusetts, United States