Myasthenia Gravis GeneralizedBioDigit MG-03NCT07226830
Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
An observational study of Myasthenia Gravis Generalized, run by BioSensics at 1 site in United States.
Trial 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®. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Myasthenia Gravis Generalized
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2027to 31 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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®
Who may be able to join
- 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)
Show all 10Show fewer
- 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
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital, Neuromuscular Diagnostic Center
Boston, Massachusetts, 02114
Amanda Guidon, MD MPH, 617-726-3642, aguidon@mgb.org
About this study
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.
Read more
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®.
Read the 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.
- Conditions
- Myasthenia Gravis Generalized
- Keywords
- myasthenia gravis, digital health, wearable sensors
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| gMG group | All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in total score of Myasthenia Gravis Activities of Daily Living (MG-ADL) Questionnaire 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.
Measured: From baseline to 16 weeks.
Change in total score of Myasthenia Gravis Quality of Life - Revised (MGQoL-15r) 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.
Measured: 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
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.
Measured: 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
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)
Measured: 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
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).
Measured: From baseline to week 16.
Secondary outcomes (4)
Change in intelligibility when reading a standard Rainbow passage from baseline to 16 weeks as measured by BioDigit Speech
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.
Measured: 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
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.
Measured: From baseline to 16 weeks.
Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire 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.
Measured: From baseline to 16 weeks.
Change in total score of the Quantitative Myasthenia Gravis (QMG) scale 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.
Measured: From baseline to 16 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2025
- Study start15 Mar 2027 (estimated)
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myasthenia Gravis GeneralizedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioSensics
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07226830
- Sponsor's protocol ID
- BioDigit MG-03
- Acronym
- BioDigit MG-03
- Status last verified
- Oct 2026
- First submitted
- 7 Nov 2025
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quantification of Change in MG Disease Activity in Individuals With Generalized Myasthenia Gravis (gMG) After Administration of VYVGART® or VYVGART Hytrulo® Using BioDigit MG
- ClinicalTrials.gov ID
- NCT07226830
- Acronym / sponsor ID
- BioDigit MG-03 / BioDigit MG-03
- Conditions
- Myasthenia Gravis Generalized
- Keywords
- myasthenia gravis, digital health, wearable sensors
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- BioSensicsIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital
- Study start
- 15 Mar 2027 (estimated)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 12 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| gMG group | – | –All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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®
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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)
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).
4 secondary outcomes
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.
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.
Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 16 weeks
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myasthenia Gravis Generalized, run by BioSensics at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ashkan Vaziri, PhD (8885896213, ashkan.vaziri@biosensics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.