Trial Outcomes & Findings for A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis (NCT NCT04650854)

Last Updated: 2025-04-18

Results Overview

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which did not necessarily had 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. TEAE was defined as any event that was not present prior to first dose of investigational medicinal product (IMP), or any unresolved event already present that worsened in intensity following treatment, up to 8 weeks after end of Treatment Period or after last dose of IMP in participants who discontinued study or IMP.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

165 participants

Primary outcome timeframe

From Baseline (Day 1) to End of Study (up to 34 months)

Results posted on

2025-04-18

Participant Flow

The study started to enroll participants in February 2021 and concluded in January 2024. Participant Flow refers to Full Analysis Set (FAS).

Participants who completed MG0003 (NCT03971422) or required rescue therapy during Observation Period (OP) in MG0003 (except for participants who received intravenous immunoglobulin/plasma exchange in MG0003) or completed at least 6 treatment visits in MG0004 (NCT04124965) were enrolled in this study.

Participant milestones

Participant milestones
Measure	Enrolled, But Not Treated Participants were enrolled but did not receive a treatment cycle of Rozanolixizumab (RLZ) in MG0007 per the Investigator's discretion.	Rozanolixizumab ~7 mg/kg Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Overall Study STARTED	8	80	77
Overall Study COMPLETED	3	15	16
Overall Study NOT COMPLETED	5	65	61

Reasons for withdrawal

Reasons for withdrawal
Measure	Enrolled, But Not Treated Participants were enrolled but did not receive a treatment cycle of Rozanolixizumab (RLZ) in MG0007 per the Investigator's discretion.	Rozanolixizumab ~7 mg/kg Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Overall Study Adverse Event	1	12	14
Overall Study Lack of Efficacy	1	3	6
Overall Study Lost to Follow-up	1	1	0
Overall Study Withdrawal by Subject	2	17	9
Overall Study Last Treatment Per Sponsor Lplv Timelines	0	12	6
Overall Study Participant Withdrawn After Drug Approved By FDA	0	0	1
Overall Study Pi Withdrew the Patients From the Study	0	0	1
Overall Study Withdraw Per Sponsor's Directive	0	1	0
Overall Study Withdrawal Due to Prohibited Treatment	0	0	1
Overall Study Use of Rescue Medication	0	0	1
Overall Study Last Treatment Per Sponsor	0	0	2
Overall Study Rescue Medication	0	0	1
Overall Study Participant Want to Start a Family	0	0	1
Overall Study Withdraw Based on Sponsor Decision	0	0	1
Overall Study Participant Screened For MG0020	0	2	3
Overall Study Patient Withdrawn Due To Inappropriate Behavior	0	1	0
Overall Study Subject Performed PEOT, Not a Completed Subject	0	1	0
Overall Study Participant to Be Screened for MG0020 Study	0	4	5
Overall Study End Of Study	0	2	1
Overall Study Wish To Continue Study IMP in Patient Programme	0	1	0
Overall Study Participant Received Rescue Medication	0	1	0
Overall Study Patient Withdrawn; Lack of IMP Shipments	0	2	1
Overall Study Last Treatment Per Lplv, Screened For MG0020	0	2	2
Overall Study Discontinued Due to Chronic Heart Failure	0	0	1
Overall Study Last Treatment Per Sponsor Lplv Timelines- Japan	0	3	3
Overall Study Enrollment Cup	0	0	1

Baseline Characteristics

A Study to Evaluate Rozanolixizumab in Study Participants With Generalized Myasthenia Gravis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Enrolled, But Not Treated n=8 Participants Participants were enrolled but did not receive a treatment cycle of Rozanolixizumab (RLZ) in MG0007 per the Investigator's discretion.	Rozanolixizumab ~7 mg/kg n=80 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=77 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Total n=165 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 17.6 • n=5 Participants	52.5 years STANDARD_DEVIATION 15.7 • n=7 Participants	52.2 years STANDARD_DEVIATION 17.0 • n=5 Participants	52.7 years STANDARD_DEVIATION 16.4 • n=4 Participants
Age, Customized 18 to <65 years	5 Participants n=5 Participants	61 Participants n=7 Participants	57 Participants n=5 Participants	123 Participants n=4 Participants
Age, Customized 65 to <85 years	2 Participants n=5 Participants	19 Participants n=7 Participants	19 Participants n=5 Participants	40 Participants n=4 Participants
Age, Customized >=85 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	45 Participants n=7 Participants	48 Participants n=5 Participants	96 Participants n=4 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	35 Participants n=7 Participants	29 Participants n=5 Participants	69 Participants n=4 Participants
Race/Ethnicity, Customized American Indian/Alaskan native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Asian	0 Participants n=5 Participants	8 Participants n=7 Participants	8 Participants n=5 Participants	16 Participants n=4 Participants
Race/Ethnicity, Customized Black	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Race/Ethnicity, Customized Native Hawaiian or other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants	1 Participants n=4 Participants
Race/Ethnicity, Customized White	4 Participants n=5 Participants	54 Participants n=7 Participants	54 Participants n=5 Participants	112 Participants n=4 Participants
Race/Ethnicity, Customized Other/mixed	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race/Ethnicity, Customized Missing	1 Participants n=5 Participants	15 Participants n=7 Participants	13 Participants n=5 Participants	29 Participants n=4 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants	10 Participants n=4 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	3 Participants n=5 Participants	63 Participants n=7 Participants	60 Participants n=5 Participants	126 Participants n=4 Participants

PRIMARY outcome

Timeframe: From Baseline (Day 1) to End of Study (up to 34 months)

Population: Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Participants who switched doses were counted in both Rozanolixizumab (RLZ) doses.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=102 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=102 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	78.4 percentage of participants	94.1 percentage of participants

PRIMARY outcome

Timeframe: From Baseline (Day 1) to End of Study (up to 34 months)

Population: Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Participants who switched doses were counted in both RLZ doses.

An adverse event (AE) was any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product, which does not necessarily have a causal relationship with this treatment. AEs leading to permanent withdrawal of study medication.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=102 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=102 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Percentage of Participants With TEAEs Leading to Withdrawal of Investigational Medicinal Product (IMP)	9.8 percentage of participants	16.7 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

Population: Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint.

The MG-ADL is an 8-item PRO instrument developed on basis of QMG. The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0= no symptoms or impaired performance and 3= most severe symptoms or impaired performance. The total score ranges from 0 to 24, with higher score indicating more disability. A positive change in score indicates worsening and negative change indicates improvement. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline \[Day 1\]) value for that cycle.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=74 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=66 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1: Treatment (Day 43)	-3.7 score on a scale Standard Deviation 3.5	-3.1 score on a scale Standard Deviation 2.9
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2: Treatment (Day 43)	-2.9 score on a scale Standard Deviation 3.1	-3.8 score on a scale Standard Deviation 3.9
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3: Treatment (Day 43)	-3.3 score on a scale Standard Deviation 2.7	-3.2 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

The QMG is a validated assessment and the scale tested 13 items, including ocular and facial involvement, swallowing, speech, limb strength, and forced vital capacity. The total QMG score was obtained by summing the responses to each individual item (13 items; Responses: None=0, Mild=1, Moderate=2, Severe=3) and the score ranges from 0 to 39, with lower scores indicating lower disease activity. A positive change in the score indicates worsening and a negative change indicates improvement. For the analyses done by study cycle, Baseline values were the last available values prior to or on the same date (and same time if time was collected for the individual assessment) of first administration of IMP at each cycle (ie, Baseline \[Day 1\]) value for that cycle.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=73 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=64 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1: Treatment (Day 43)	-4.5 score on a scale Standard Deviation 5.0	-4.1 score on a scale Standard Deviation 4.2
Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2: Treatment (Day 43)	-3.9 score on a scale Standard Deviation 4.1	-4.9 score on a scale Standard Deviation 5.5
Change From Baseline (Day 1) to Day 43 in Quantitative Myasthenia Gravis (QMG) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3: Treatment (Day 43)	-5.1 score on a scale Standard Deviation 4.8	-4.2 score on a scale Standard Deviation 4.4

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

Population: Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed included participants who were evaluable for the assessment. Number Analyzed included participants who were evaluable at specified timepoint.

MG-C scale consists of 10 items which included ptosis (score range=0 to 3), double vision on lateral gaze left/right/both (score range=0 to 4), eye closure (score range=0 to 2), talking (score range=0 to 6), chewing (score range=0 to 6), swallowing (score range=0 to 6), breathing (score range=0 to 9), neck flexion or extension (score range=0 to 4), shoulder abduction (score range=0 to 5) and hip flexion (score range= 0 to 5), lower scores= lower disease activity. Total MG-C score obtained by summing responses to each individual item and score ranges from 0 - 50, (lower scores indicating lower disease activity). Positive change = worsening, and negative change = improvement. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline \[Day 1\]) value for that cycle.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=73 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=66 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1: Treatment (Day 43)	-7.6 score on a scale Standard Deviation 7.3	-4.7 score on a scale Standard Deviation 5.7
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2: Treatment (Day 43)	-5.7 score on a scale Standard Deviation 5.4	-7.5 score on a scale Standard Deviation 7.0
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis-Composite (MG-C) Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3: Treatment (Day 43)	-6.8 score on a scale Standard Deviation 5.9	-6.1 score on a scale Standard Deviation 7.2

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

Population: Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint.

The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular symptoms (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option that best described severity of ocular, bulbar, and respiratory symptoms over past 7 days using a 4-point Likert scale ("none" to "severe") and frequency of experiencing physical fatigue and muscle weakness fatigability over past 7 days using a 5-point Likert scale (1="none of the time" - 5= "all of the time"), for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicates more severe symptoms. For analyses done by study cycle, Baseline values were last available values prior to or on the same date of first administration of IMP at each cycle (Baseline \[Day 1\]) value for that cycle.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=75 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=66 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1: Treatment (Day 43)	-17.6 score on a scale Standard Deviation 21.0	-14.6 score on a scale Standard Deviation 17.2
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2: Treatment (Day 43)	-13.2 score on a scale Standard Deviation 19.2	-19.2 score on a scale Standard Deviation 21.6
Change From Baseline (Day 1) to Day 43 in Myasthenia Gravis (MG) Symptoms Patient Reported Outcome (PRO) 'Muscle Weakness Fatigability' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3: Treatment (Day 43)	-12.8 score on a scale Standard Deviation 14.4	-15.4 score on a scale Standard Deviation 17.7

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Study participants had to choose response option based on frequency of experiencing physical fatigue (19-33) over past 7 days using a 5-point Likert scale (1="none of time" - 5="all of time") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=75 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=66 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1: Treatment (Day 43)	-16.5 score on a scale Standard Deviation 18.6	-14.8 score on a scale Standard Deviation 18.5
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2: Treatment (Day 43)	-13.6 score on a scale Standard Deviation 21.6	-16.0 score on a scale Standard Deviation 18.2
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Physical Fatigue' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3: Treatment (Day 43)	-15.3 score on a scale Standard Deviation 16.9	-15.0 score on a scale Standard Deviation 18.4

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

Population: Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed: participants who were evaluable for the assessment. Number Analyzed included those participants who were evaluable at specified timepoint.

The MG symptoms PRO instrument consisted of 42 items across 5 scales: ocular muscle weakness (1-5); bulbar muscle weakness (6-15); respiratory muscle weakness (16-18); physical fatigue (19-33) and muscle weakness fatigability (34-42). Bulbar symptoms are now recognised as bulbar muscle weakness. Study participants were asked to choose response option that best described severity of bulbar muscle weakness (6-15) symptoms over past 7 days using a 4-point Likert scale (1="none" to 4="severe") for each item. Sum of each item score is linearly transformed to have all domain scores ranging from 0 to 100, higher scores indicated severe symptoms.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=75 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=66 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1: Treatment (Day 43)	-13.4 score on a scale Standard Deviation 19.8	-11.6 score on a scale Standard Deviation 16.2
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2: Treatment (Day 43)	-10.4 score on a scale Standard Deviation 16.2	-15.5 score on a scale Standard Deviation 18.1
Change From Baseline (Day 1) to Day 43 in MG Symptoms PRO 'Bulbar Muscle Weakness' Score Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3: Treatment (Day 43)	-14.0 score on a scale Standard Deviation 16.8	-13.0 score on a scale Standard Deviation 17.9

SECONDARY outcome

Timeframe: Day 43 of Cycle 1, 2, and 3

Population: Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number of Participants Analyzed included those participants who were evaluable for the assessment. Number Analyzed: participants who were evaluable at specified timepoint.

The MG-ADL is an 8-item PRO instrument developed on the basis of the Quantitative Myasthenia Gravis (QMG). The MG-ADL targeted symptoms and disability across ocular, bulbar, respiratory, and axial symptoms. The total MG-ADL score was obtained by summing the responses to each individual item (8 items; Grades: 0, 1, 2, 3), where 0 represents no symptoms or impaired performance and 3 represents the most severe symptoms or impaired performance. The total score ranges from 0 to 24, with a higher score indicating more disability. A MG-ADL responder was defined as achieving at least 2.0-point improvement (decrease) in the MG-ADL score from Baseline.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=74 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=66 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) Cycle 1: Treatment (Day 43)	74.3 percentage of participants	63.6 percentage of participants
MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) Cycle 2: Treatment (Day 43)	62.5 percentage of participants	67.7 percentage of participants
MG-ADL Responder Rate (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3 [Day 43]) Cycle 3: Treatment (Day 43)	73.2 percentage of participants	67.2 percentage of participants

SECONDARY outcome

Timeframe: From Baseline (Day 1) to Day 43 of each cycle (Cycles 1, 2, and 3)

Population: Safety Set (SS): All study participants in the FAS who received at least one dose of IMP. Number Analyzed: participants who were evaluable at specified timepoint.

Time to achieve MG-ADL response, defined as at least 2.0-point improvement from Baseline. Time to first MG-ADL response (in days) by study cycle was defined as date of first MG-ADL Response within study cycle - date of MG-ADL Baseline within study cycle + 1.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=80 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=77 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 1	9.00 days Interval 8.0 to 15.0	22.00 days Interval 15.0 to 36.0
Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 2	15.00 days Interval 10.0 to 17.0	15.00 days Interval 9.0 to 22.0
Time to MG-ADL Response (>=2.0-point Improvement From Baseline [Day 1]) Within One Treatment Cycle (Cycle 1, 2, and 3) Cycle 3	15.00 days Interval 9.0 to 15.0	15.00 days Interval 9.0 to 17.0

SECONDARY outcome

Timeframe: From end of the 6-week treatment cycle (Day 43) to the next 6-week treatment cycle (Day 1), assessed up to 2.5 years

Population: Safety Set (SS): All study participants in FAS who received at least 1 dose of IMP. Number Analyzed: participants who were evaluable at specified timepoint.

Time between consecutive treatment cycles: Study participants were assessed for MG worsening prior to repeated cycles. In case of symptom worsening (eg, an increase of 2.0 points on MG-ADL or 3.0 points on QMG scale) between assessments, resulted additional treatment, study participants undergone another 6-week treatment cycle followed by an Observation Period, based on Investigator's discretion. Time between treatment cycles was calculated as: date of first sc infusion in consecutive cycle - date of last sc infusion before new cycle + 1 (or date of censoring - date of last sc infusion before potential new cycle + 1).

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=80 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of subcutaneous (sc) dose of Rozanolixizumab (RLZ) equivalent to approximately 7 milligrams/kilogram (mg/kg) once weekly (QW), followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, premature end of treatment (PEOT) Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.	Rozanolixizumab ~10 mg/kg n=77 Participants Eligible participants from MG0003 were randomized to receive an initial fixed 6-week treatment cycle of sc dose of RLZ equivalent to approximately 10 mg/kg QW, followed by OP that began after last dose of that treatment cycle. Eligible participants from MG0004 who completed at least 6 scheduled visits for RLZ treatment, PEOT Visit and who were in OP could complete End of Study Visit could move directly into OP in MG0007. These participants underwent their first MG0007 treatment with RLZ upon worsening of MG symptoms. Participants continued their last treatment dose from MG0004. Dose adjustments could be applied in further cycles as per Investigator's discretion. If symptom worsens between assessments, resulting in need for additional treatment, participants underwent another 6-week treatment cycle followed by OP, based on Investigator's discretion.
Time Between Consecutive Treatment Cycles Between Cycle 1 and Cycle 2	64.0 days Interval 9.0 to 883.0	51.0 days Interval 2.0 to 856.0
Time Between Consecutive Treatment Cycles Between Cycle 2 and Cycle 3	58.0 days Interval 1.0 to 631.0	50.0 days Interval 15.0 to 575.0
Time Between Consecutive Treatment Cycles Between Cycle 3 and Cycle 4	42.5 days Interval 27.0 to 399.0	43.0 days Interval 5.0 to 194.0
Time Between Consecutive Treatment Cycles Between Cycle 4 and Cycle 5	43.0 days Interval 9.0 to 181.0	43.0 days Interval 17.0 to 242.0
Time Between Consecutive Treatment Cycles Between Cycle 5 and Cycle 6	44.0 days Interval 22.0 to 192.0	43.0 days Interval 15.0 to 175.0
Time Between Consecutive Treatment Cycles Between Cycle 6 and Cycle 7	36.0 days Interval 8.0 to 348.0	43.0 days Interval 7.0 to 106.0
Time Between Consecutive Treatment Cycles Between Cycle 7 and Cycle 8	37.0 days Interval 22.0 to 87.0	37.0 days Interval 6.0 to 84.0
Time Between Consecutive Treatment Cycles Between Cycle 8 and Cycle 9	36.0 days Interval 8.0 to 120.0	36.0 days Interval 7.0 to 134.0
Time Between Consecutive Treatment Cycles Between Cycle 9 and Cycle 10	29.0 days Interval 7.0 to 97.0	29.0 days Interval 8.0 to 72.0
Time Between Consecutive Treatment Cycles Between Cycle 10 and Cycle 11	29.0 days Interval 8.0 to 64.0	29.0 days Interval 8.0 to 99.0
Time Between Consecutive Treatment Cycles Between Cycle 11 and Cycle 12	23.0 days Interval 8.0 to 52.0	22.0 days Interval 7.0 to 37.0
Time Between Consecutive Treatment Cycles Between Cycle 12 and Cycle 13	22.0 days Interval 6.0 to 36.0	22.0 days Interval 7.0 to 38.0
Time Between Consecutive Treatment Cycles Between Cycle 13 and Cycle 14	29.0 days Interval 22.0 to 35.0	16.0 days Interval 8.0 to 65.0
Time Between Consecutive Treatment Cycles Between Cycle 14 and Cycle 15	29.0 days Interval 29.0 to 64.0	9.0 days Interval 8.0 to 16.0
Time Between Consecutive Treatment Cycles Between Cycle 15 and Cycle 16	23.0 days Interval 8.0 to 29.0	26.5 days Interval 9.0 to 44.0
Time Between Consecutive Treatment Cycles Between Cycle 16 and Cycle 17	29.0 days Interval 29.0 to 29.0	—
Time Between Consecutive Treatment Cycles Between Cycle 17 and Cycle 18	8.0 days Interval 8.0 to 8.0	—

Adverse Events

Enrolled, But Not Treated

Serious events: 3 serious events

Other events: 5 other events

Deaths: 1 deaths

Rozanolixizumab ~7 mg/kg

Serious events: 16 serious events

Other events: 67 other events

Deaths: 1 deaths

Rozanolixizumab ~10 mg/kg

Serious events: 31 serious events

Other events: 78 other events

Deaths: 3 deaths

Serious adverse events

Other adverse events

Additional Information

UCB

Cares

Phone: 001 844 599 2273

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: GT60