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

NCT07226830 | Not Yet Recruiting

• 1 other identifier: BioDigit MG-03
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

Brief 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®.

Conditions

Myasthenia Gravis Generalized

Keywords

myasthenia gravis; digital health; wearable sensors

Outcome Measures

Primary Outcomes (5)

• 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.

  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.

  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.

  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)

  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).

  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

  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

  From baseline to 16 weeks.

• Change in total score of the Myasthenia Garvis Composite (MGC) questionnaire from baseline to 16 weeks

  From baseline to 16 weeks.

• Change in total score of the Quantitative Myasthenia Gravis (QMG) scale from baseline to 16 weeks

  From baseline to 16 weeks.

Other Outcomes (5)

• 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

  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

  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

  From baseline to 16 weeks.

Study Arms (1)

gMG group

All participants meeting the study inclusion criteria will be assigned to this group to complete the study activities

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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®

You may qualify if:

• 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

You may not qualify if:

• 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).

Sponsors & Collaborators

• BioSensics: lead
• Massachusetts General Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital, Neuromuscular Diagnostic Center

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Myasthenia Gravis

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Ashkan Vaziri, PhD

CONTACT

8885896213; ashkan.vaziri@biosensics.com

Ana Enriquez

CONTACT

8885896213; ana.enriquez@biosensics.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 7, 2025
• First Posted: November 12, 2025
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 31, 2028
• Study Completion (Estimated): March 31, 2028
• Last Updated: November 12, 2025

Record last verified: 2025-11

Locations

US (1)