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

Conditions

• Myasthenia Gravis Generalized

Eligibility Criteria

Sex

ALL

Age

18 Years - 80 Years

Healthy Volunteers

Not accepted

Study Details

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 Dates

Start date

Jan 15, 2026

Status verified

Nov 2025

Primary completion

Jan 31, 2028

Completion

Mar 31, 2028

Study Design

Enrollment

25 participants (estimated)

Arms

• Arm: gMG group
  All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities

Primary Outcome Measure

Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire from baseline to 16 weeks [ Time Frame: From baseline to 16 weeks. ]

Central Contacts

• Ashkan Vaziri, PhD
  8885896213
  [email protected]
• Ana Enriquez
  8885896213
  [email protected]

Locations (1)

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