Registered outcomes13

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 13 of 13

List	Outcome	Time frame	Description
Primary	Occurrence of serious Treatment-Emergent Adverse Events (TEAEs) up to the End of Study (EOS) Visit	From Baseline up to the EOS Visit (up to 18 weeks)	Serious TEAEs are any untoward medical incidence in a subject during administered study treatment, whether or not these events are related to study treatment and additionally are emergent untoward medical occurrence that at any dose: * Results in death * Is life-threatening * Requires in patient hospitalisation or prolongation of existing hospitalisation * Results in persistent disability/incapacity * Is a congenital anomaly or birth defect * Important medical events
Primary	Occurrence of TEAEs leading to permanent withdrawal of Investigational Medicinal Product (IMP) up to the EOS Visit	From Baseline up to the EOS Visit (up to 18 weeks)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Primary	Occurrence of Adverse Event(s) of Special Monitoring (AESM) up to the EOS Visit (up to 18 weeks)	From Baseline up to the EOS Visit (up to 18 weeks)	AESMs are: Severe and/or serious headache, suspected aseptic meningitis, severe Gastrointestinal (GI) disorders, and opportunistic infection.
Secondary	Percent change in total Immunoglobulin G (IgG) from Baseline at the end of Week 6	From Baseline to the end of Week 6	Plasma concentration analyses of total IgG will be done for all study participants on an ongoing basis throughout the study.
Secondary	Absolute change in total IgG from Baseline at the end of Week 6	From Baseline to the end of Week 6	Plasma concentration analyses of total IgG will be done for all study participants on an ongoing basis throughout the study.
Secondary	Percent change from Baseline in myasthenia gravis (MG) autoantibody levels at the end of Week 6	From Baseline to the end of Week 6	Plasma concentration analyses of MG specific anti-acetylcholine receptor (AChR) or anti-muscle-specific kinase (MuSK) autoantibodies will be done for all study participants on an ongoing basis throughout the study.
Secondary	Absolute change from Baseline in MG-specific autoantibody levels at the end of Week 6	From Baseline to the end of Week 6	Plasma concentration analyses of anti-AChR or anti-MuSK autoantibodies will be done for all study participants on an ongoing basis throughout the study.
Secondary	Change from Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score at the end of Week 6	From Baseline to the end of Week 6	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.
Secondary	Change from Baseline in Quantitative Myasthenia Gravis (QMG) total score at the end of Week 6	From Baseline to the end of Week 6	QMG score is a standardized and validated quantitative strength scoring system that was developed specifically for MG. The QMG total score is obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3). The score ranges from 0 to 39, with lower scores indicating lower disease activity.
Secondary	Occurrence of other TEAEs (including headache, nausea, and infusion site reactions) during Treatment Period 1 (TP1) and Observation Period 1 (OP1)	During TP1 and OP1 (up to 14 weeks)	An Adverse Event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product.
Secondary	Evaluation of local tolerability at each scheduled assessment during TP1	At each scheduled assessment during TP1 (Baseline, week 2, 3, 4, 5, up to 6 weeks)	Local tolerability will be evaluated at each scheduled assessment for all study participants during TP1.
Secondary	Plasma concentration of rozanolixizumab at the 6-week treatment cycle	At the 6-week treatment cycle	Plasma concentration analyses of rozanolixizumab will be done for all study participants on an ongoing basis throughout the study.
Secondary	Incidence of antidrug antibodies (ADAs) at the end of Week 6	At the end of Week 6	Plasma concentration analyses of ADAs will be done for all study participants on an ongoing basis throughout the study.

Source ClinicalTrials.govtrials-2026-11-12-0.4.0

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNone stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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