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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
StatusNot Yet Recruiting
PhaseNot specified
SponsorBioSensics
Started
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Record History

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  1. Start date: Jan 15, 2026 to Mar 15, 2027
    • Eligibility criteria expanded, about 16 words
    • Secondary endpoints: details revised at 4 of 4 entries
  2. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
BioSensics
8 trials monitored
See 1 trial at risk
Myasthenia Gravis
193 trials monitored
See 7 trials at risk
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
(from sponsor)		 Myasthenia Gravis Generalized
Related terms Myasthenia Gravis
Enrollment 25 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov