Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG (BioDigit MG-03)

November 9, 2025 updated by: BioSensics

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®.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

MG is a chronic autoimmune neuromuscular disease characterized by fluctuating muscle weakness that interferes with activities of daily living. Ocular, facial, swallowing, neck, limb and breathing muscles can be affected. The prevalence of MG is estimated at approximately 60,000 patients in the United States. MG symptoms are currently assessed in person through a careful history and physical exam by a neuromuscular disease expert. This is time-consuming, costly, and poses challenges in a chronic disease with fluctuating symptoms, where patients may not demonstrate any abnormality at the time of in-clinic assessment. The principal means of measuring disease severity are specific scales such as the MGC, QMG and the MG Manual Muscle Testing (MMT) scales. Although valuable, these scales are subjective and require training to administer correctly. Additionally, they provide only snapshot of a patient's disease and do not adequately reflect the spectrum of fluctuating weakness, which is a hallmark of MG. Wearable sensors and digital health technologies could enable objective, sensitive, continuous assessment of physical activity as well as motor and ocular impairments in individuals with MG.

BioSensics LLC (Newton, MA) is a medical device company specializing in wearable sensors and digital health technology for healthcare. BioSensics LLC offers a wearable sensor system and digital health solution for long-term remote monitoring of motor performance during everyday life.

This is an analytic observational study following participants over the course of 16 weeks. Subjects diagnosed with gMG who are initiating treatment with VYVGART® or VYVGART Hytrulo® will be screened and recruited to participate in this non--interventional study.

In addition to standard clinical assessments, the study will leverage BioDigit MG to remotely collect high-frequency wearable and digital health data from participants in their home environments during two treatment cycles with VYVGART® or VYVGART Hytrulo®. The frequency of at-home data collection is increased during the first 2 weeks and last 2 weeks of each treatment cycle to provide a more granular data both the initial phase (first two weeks) and the last two weeks of each treatment cycle. A key objective of the project is to measure changes in disease symptoms using both patient reported outcomes (PROs) and digital measures in individuals with gMG during the treatment cycles. The investigators will also evaluate if the combination of sensors-derived and digital measures from the BioDigit MG serves as a significant early predictor of the standard clinical outcomes.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital, Neuromuscular Diagnostic Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Individuals with gMG with MGFA severity class IIa/b, IIIa/b or IVa/b who are initiating treatment with VYVGART® or VYVGART Hytrulo®

Description

Inclusion Criteria:

  • Diagnosis of autoimmune MG with or without history of thymoma
  • MGFA severity class IIa/b, IIIa/b or IVa/b at the screening visit
  • Diagnosed gMG through one or more of the following:
  • Positive acetylcholine receptor antibody (AChR Ab) test, or
  • Abnormal neuromuscular transmission demonstrated by single-fiber electromyography (SFEMG) or repetitive nerve stimulation (RNS), or
  • Documented positive response to standard MG therapies (e.g., AChE inhibitors, IVIG/PLEX, FcRn antagonists or C5 inhibitors)
  • Currently initiating treatment with VYVGART® or VYVGART Hytrulo®
  • Physically and cognitively able to provide informed consent and adhere to the study procedures, as determined by the investigator.
  • Ambulatory, defined as the ability to walk at least 10 meters independently, with or without the use of an assistive device.
  • Speaks and reads English fluently

Exclusion Criteria:

  • Inability to perform essential activities of daily living required for independent living, such as dressing, bathing, toileting, or eating without assistance.
  • Presence of neurological or orthopedic conditions unrelated to MG that, in the investigator's judgment, significantly impair gait or daily functioning.
  • Any clinically significant medical, laboratory, or psychiatric condition that, in the opinion of the investigator, could interfere with study participation or data integrity.
  • Current residence in a long-term care or institutional facility (e.g., nursing home, skilled nursing facility), receipt of hospice care, or incarceration.
  • MGFA severity classification of Class I or Class V (myasthenic crisis). Pregnant or breastfeeding women.
  • Concurrent participation in another interventional clinical trial (participation in observational studies, biomarker studies, or registries is permitted).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
gMG group
All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Scores for the MG-ADL range from 0-24. A lower score represents a better outcome and a higher score is a worse outcome. Collected 11 times at home, and once at each clinical visit.
From baseline to 16 weeks.
Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) from baseline to 16 weeks
Time Frame: From baseline to 16 weeks.
Scores for the MGQoL-15R range from 0-30. A lower score represents a better outcome and a higher score is a worse outcome. Collected 11 times at home, and once at each clinical visit.
From baseline to 16 weeks.
Change in total score of Quality of Life in Neurological Disorders - Fatigue (Neuro-QoL Fatigue) from baseline to 16 weeks
Time Frame: From baseline to 16 weeks. Collected 11 times at home, and once at each clinical visit.
Scores for the Neuro-QoL Fatigue range from 8-40. A lower score represents a better outcome and a higher score is a worse outcome.
From baseline to 16 weeks. Collected 11 times at home, and once at each clinical visit.
Change in daily walking duration during activities of daily living from baseline to 16 weeks as measured by the PAMSys pendant
Time Frame: From baseline to 16 weeks.
Daily walking duration (hours) will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, Visit 2 (approximately week 8) , and Visit 3 (approximately week 16)
From baseline to 16 weeks.
Change in daily number of sit to stand transitions (count) during activities of daily living from baseline to 16 weeks as measured by the PAMSys pendant
Time Frame: From baseline to week 16.
Daily number of sit to stand transitions will be measured by the PAMSys pendant. PAMSys is a FDA-listed Class II wearable device for measuring physical activity and posture during activities of daily living. PAMSys will be worn for 1 week before the baseline, Visit 2 (approximately week 8), and Visit 3 (approximately week 16).
From baseline to week 16.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in intelligibility when reading a standard Rainbow passage from baseline to 16 weeks as measured by BioDigit Speech
Time Frame: From baseline to 16 weeks.

Speech data will be collected from participants while reading a standard Rainbow passage. Speech data will be collected 11 times using the at-home platform. Speech data will also be collected at each clinical visit.

BioDigit Speech, an automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage.
From baseline to 16 weeks.
Change in Marginal Reflex Distance-1 during the upward gaze test as measured by BioDigit Video from baseline to 16 weeks
Time Frame: From baseline to 16 weeks.

Video data will be collected from participants while performing a standard upward gaze test. Video data will be collected 11 times using the at-home platform. Video data will also be collected at each clinical visit.

BioDigit Video, an automatic video analysis software, will be used to analyze the collected video data to calculate Marginal Reflex Distance-1 during the upward gaze test.
From baseline to 16 weeks.
Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 16 weeks
Time Frame: From baseline to 16 weeks.
Scores for the MGC range from 0-50. A lower score represents a better outcome and a higher score is a worse outcome. Collected once at each clinical visit.
From baseline to 16 weeks.
Change in total score of the Quantitative Myasthenia Gravis (QMG) scale from baseline to 16 weeks
Time Frame: From baseline to 16 weeks.
Scores for the QMG range from 0-39. A lower score represents a better outcome and a higher score is a worse outcome. Collected once at each clinical visit.
From baseline to 16 weeks.

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in daily mean heart rate (beats per minute or BPM) during activities of daily living from baseline to 16 weeks as measured by the Samsung Galaxy watch
Time Frame: From baseline to 16 weeks.
Heart rate will be measured during activities of daily living using the Samsung Galaxy watch. Samsung Galaxy watch will be worn continuously from 1 week prior to baseline until the end of study visit.
From baseline to 16 weeks.
Change in forced vital capacity during a standard spirometer breathing test from baseline to 16 weeks as measured by a FDA-listed spirometer
Time Frame: From baseline to 16 weeks.
Forced vital capacity (FVC) will be measured directly by the spirometer during a standard breathing assessment. The FVC will be measured in Litres. FVC will be collected 11 times at home, and once at each clinical visit.
From baseline to 16 weeks.
Change in mean articulatory rate when reading a standard Rainbow passage from baseline to 16 weeks as measured by BioDigit Speech
Time Frame: From baseline to 16 weeks.

Speech data will be collected from participants while reading a standard Rainbow passage. Speech data will be collected 11 times using the at-home platform. Speech data will also be collected at each clinical visit.

BioDigit Speech, an automatic speech analysis software, will be used to analyze the collected speech data to calculate intelligibility of speech during reading a standard Rainbow passage.
From baseline to 16 weeks.
Change in mean eye aspect ratio during the upward gaze test as measured by BioDigit Video from baseline to 16 weeks
Time Frame: Baseline to 16 weeks.

Video data will be collected from participants while performing a standard upward gaze test. Video data will be collected 11 times using the at-home platform. Video data will also be collected at each clinical visit.

BioDigit Video, an automatic video analysis software, will be used to analyze the collected video data to calculate eye aspect ratio during the upward gaze test.
Baseline to 16 weeks.
Change in daily mean heart rate variability during activities of daily living from baseline to 16 weeks as measured by the Samsung Galaxy watch
Time Frame: From baseline to 16 weeks.
Heart rate variability will be measured during activities of daily living using the Samsung Galaxy watch. Samsung Galaxy watch will be worn continuously from 1 week prior to baseline until the end of study visit
From baseline to 16 weeks.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
BioSensics

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 15, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 7, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 12, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 12, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 9, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • BioDigit MG-03

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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