Исследование по оценке долгосрочной безопасности и эффективности розаниликсимаба у взрослых участников с глазной формой миастении гравис (MyVisionXT)

The study is composed of Extended Observation Period(s) and Symptom-driven Cycle(s). Based on their clinical need for treatment, study participants will be able to start the study with either an Extended Observation Period or a Symptom-driven Cycle.

A Symptom-driven Cycle will be initiated based on disease worsening and participants will receive rozanolixizumab based on investigator's medical judgement.

Rozanolixizumab will be administered by subcutaneous infusion.

• UCB7665

Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment.

An SAE is defined as any untoward medical occurrence that, at any dose, meets 1 or more of the criteria listed:

• Results in death
• Is life-threatening
• Requires inpatient hospitalization or prolongation of existing hospitalization
• Results in persistent or significant disability/incapacity
• Is a congenital anomaly/birth defect
• Other important medical events which based on medical or scientific judgement may jeopardize the patients or may require medical or surgical intervention to prevent any of the above.

Treatment Emergent Adverse Events (TEAEs) are any untoward medical incidence in a participant after the administration of study treatment, whether or not these events are related to study treatment. This measure considers any TEAE leading to permanent withdrawal from study.

MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week".

The MG-ADL score is an 8-item patient-reported outcome (PRO) instrument. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability. The two ocular items will be summed for the ocular score, ranging from 0 to 6.

The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (items 1-5); bulbar muscle weakness (items 6-15); respiratory muscle weakness (items 16-18); physical fatigue (items 19-33) and muscle weakness fatigability (items 34-42). Only the ocular muscle weakness scale will be used in this study. Ocular symptom severity is assessed over the past 7 days using a 4-point verbal rating scale (none, mild, moderate, severe)

The MG-QoL15r is a 15-item PRO measure that is designed to assess aspects of health-related quality of life related to MG. The recall period that will be used is "past 7 days". Each item has 3 response options (0-2) and the total score ranges from 0 to 30, with higher scores indicating more severe impact on health-related QoL (HRQOL).

MGFA Clinical Classification is a 5-stage classification (I to V), with a higher class indicating more severe disease.

MGII is a measure of disease severity based on the signs and symptoms of MG patients. The MGII has 22 patient-reported items and 6 examination items and scores are presented as a sum of all items for a total score but also as an ocular and generalized sub-score. The scoring range is 0 to 84, 0-23 for the ocular score, and 0-61 for the generalized score, where higher scores are indicative of more severe symptoms. The recall period is "the past week".

The MG-ADL score is an 8-item patient-reported outcome (PRO) instrument. The MG-ADL targets symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability. The two ocular items will be summed for the ocular score, ranging from 0 to 6.