Trial Outcomes & Findings for A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis (NCT NCT04124965)

Last Updated: 2023-09-05

Results Overview

A TEAE is defined as an AE starting on or after the time of first administration of investigational medicinal product (IMP) or any unresolved event already present before the first administration of IMP that worsened in intensity following exposure to IMP, up to 8 weeks after the last dose of IMP in study participants who discontinued the study or IMP.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

71 participants

Primary outcome timeframe

From Baseline until End of Study (up to Week 60)

Results posted on

2023-09-05

Participant Flow

The study started to enroll study participants in Oct 2019 and concluded in Sep 2021.

Participant Flow refers to the Randomized Set.

Participant milestones

Participant milestones
Measure	Rozanolixizumab ~7 mg/kg Participants received rozanolixizumab equivalent to approximately 7 milligrams/kilogram (mg/kg), subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Overall Study STARTED	35	36
Overall Study Safety Set	35	35
Overall Study COMPLETED	5	3
Overall Study NOT COMPLETED	30	33

Reasons for withdrawal

Reasons for withdrawal
Measure	Rozanolixizumab ~7 mg/kg Participants received rozanolixizumab equivalent to approximately 7 milligrams/kilogram (mg/kg), subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Overall Study Adverse event, non-fatal	3	1
Overall Study Withdrawal by Subject	1	1
Overall Study Rolled Over To MG0007 Study	25	28
Overall Study Pregnancy	1	0
Overall Study Sponsor and participant decision	0	1
Overall Study Personal surgery	0	1
Overall Study Physician Decision	0	1

Baseline Characteristics

A Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Rozanolixizumab ~7 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=36 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Total n=71 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants	26 Participants n=7 Participants	55 Participants n=5 Participants
Age, Categorical >=65 years	6 Participants n=5 Participants	10 Participants n=7 Participants	16 Participants n=5 Participants
Age, Continuous	50.6 years STANDARD_DEVIATION 14.2 • n=5 Participants	53.7 years STANDARD_DEVIATION 17.2 • n=7 Participants	52.2 years STANDARD_DEVIATION 15.8 • n=5 Participants
Sex: Female, Male Female	19 Participants n=5 Participants	19 Participants n=7 Participants	38 Participants n=5 Participants
Sex: Female, Male Male	16 Participants n=5 Participants	17 Participants n=7 Participants	33 Participants n=5 Participants
Race/Ethnicity, Customized Asian	4 Participants n=5 Participants	4 Participants n=7 Participants	8 Participants n=5 Participants
Race/Ethnicity, Customized Black	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race/Ethnicity, Customized White	17 Participants n=5 Participants	19 Participants n=7 Participants	36 Participants n=5 Participants
Race/Ethnicity, Customized Missing	12 Participants n=5 Participants	9 Participants n=7 Participants	21 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic or Latino	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Not Hispanic or Latino	19 Participants n=5 Participants	25 Participants n=7 Participants	44 Participants n=5 Participants

PRIMARY outcome

Timeframe: From Baseline until End of Study (up to Week 60)

Population: The Safety Set (SS) consisted of all randomized study participants who received at least 1 dose of IMP in this study. This endpoint was planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both rozanolixizumab (RLZ) doses.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=50 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=42 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)	76.0 percentage of participants	78.6 percentage of participants

PRIMARY outcome

Timeframe: From Baseline until End of Study (up to Week 60)

Population: The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. This endpoint was planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both rozanolixizumab doses.

A TEAE is defined as an AE starting on or after the time of first administration of IMP or any unresolved event already present before the first administration of IMP that worsened in intensity following exposure to IMP, up to 8 weeks after the last dose of IMP in study participants who discontinued the study or IMP.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=50 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=42 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of Study Medication	6.0 percentage of participants	0 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60

Population: The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study. Here, number analyzed signifies those participants who were evaluable at specified time points.

The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item patient-reported outcome (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 positive change indicates worsening and a negative change indicates improvement.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 5	-2.7 units on a scale Standard Deviation 3.3	-3.2 units on a scale Standard Deviation 3.8
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 7	-2.7 units on a scale Standard Deviation 3.8	-3.7 units on a scale Standard Deviation 3.4
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 9	-2.8 units on a scale Standard Deviation 3.4	-3.4 units on a scale Standard Deviation 3.7
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 13	-3.1 units on a scale Standard Deviation 3.4	-3.9 units on a scale Standard Deviation 4.0
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 17	-2.8 units on a scale Standard Deviation 3.3	-4.0 units on a scale Standard Deviation 3.9
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 21	-3.0 units on a scale Standard Deviation 3.4	-4.1 units on a scale Standard Deviation 4.3
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 25	-2.7 units on a scale Standard Deviation 3.0	-3.7 units on a scale Standard Deviation 4.7
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 29	-2.8 units on a scale Standard Deviation 2.1	-3.6 units on a scale Standard Deviation 4.3
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 33	-3.0 units on a scale Standard Deviation 2.8	-3.5 units on a scale Standard Deviation 4.5
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 37	-3.9 units on a scale Standard Deviation 2.5	-3.6 units on a scale Standard Deviation 3.6
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 41	-2.8 units on a scale Standard Deviation 2.1	-1.8 units on a scale Standard Deviation 1.0
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 45	-3.8 units on a scale Standard Deviation 2.4	-2.1 units on a scale Standard Deviation 1.1
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 49	-2.4 units on a scale Standard Deviation 1.1	-0.5 units on a scale Standard Deviation 3.7
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 52	-2.6 units on a scale Standard Deviation 1.3	-2.0 units on a scale Standard Deviation NA NA signifies that as pre-specified in the Statistical Analysis Plan, Standard Deviation was only calculated if there were a minimum of 4 participants.
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 60	-0.3 units on a scale Standard Deviation 2.1	-1.3 units on a scale Standard Deviation 3.9

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60

MG-C scale is a validated assessment and scale tests 10 items with individual items being weighted differently. The items included ptosis/upward gaze (range: 0 \[\>45 second\] - 3 \[Immediate\]), double vision on lateral gaze (range: 0 \[\>45 second\] - 4 \[Immediate\]), eye closure (range: 0 \[Normal\] - 2 \[severe weakness\]), talking (range: 0 \[Normal\] - 6 \[difficult to understand speech\]), chewing (range: 0 \[Normal\] - 6 \[gastric tube\]), swallowing (range: 0 \[Normal\] - 6 \[gastric tube\]), breathing (range: 0 \[Normal\] - 9 \[ventilator dependence\]), neck flexion (range: 0 \[Normal\] - 4 \[severe weakness\]), shoulder abduction (range: 0 \[Normal\] - 5 \[severe weakness\]) and hip flexion (range: 0 \[Normal\] - 5 \[severe weakness\]), lower scores= lower disease activity. Total MG-C score was obtained by summing responses to each individual item and score ranges from 0 to 50, with lower scores indicating lower disease activity. A positive change indicates worsening and a negative change indicates improvement.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 5	-4.7 units on a scale Standard Deviation 5.5	-5.5 units on a scale Standard Deviation 7.3
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 7	-5.0 units on a scale Standard Deviation 5.7	-7.1 units on a scale Standard Deviation 7.4
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 9	-5.0 units on a scale Standard Deviation 5.3	-6.0 units on a scale Standard Deviation 7.4
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 13	-4.8 units on a scale Standard Deviation 5.5	-7.0 units on a scale Standard Deviation 7.8
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 17	-4.4 units on a scale Standard Deviation 5.7	-5.5 units on a scale Standard Deviation 8.6
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 21	-5.3 units on a scale Standard Deviation 6.9	-7.3 units on a scale Standard Deviation 8.1
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 25	-6.1 units on a scale Standard Deviation 5.8	-8.8 units on a scale Standard Deviation 7.7
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 29	-5.1 units on a scale Standard Deviation 5.5	-9.1 units on a scale Standard Deviation 9.2
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 33	-4.6 units on a scale Standard Deviation 5.1	-8.4 units on a scale Standard Deviation 8.6
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 37	-6.3 units on a scale Standard Deviation 6.8	-8.6 units on a scale Standard Deviation 6.9
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 41	-6.0 units on a scale Standard Deviation 7.1	-6.5 units on a scale Standard Deviation 5.8
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 45	-4.0 units on a scale Standard Deviation 6.2	-5.3 units on a scale Standard Deviation 4.9
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 49	-1.4 units on a scale Standard Deviation 3.8	-0.8 units on a scale Standard Deviation 9.2
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 52	-3.8 units on a scale Standard Deviation 3.1	NA units on a scale Standard Deviation NA NA signifies that as pre-specified in the Statistical Analysis Plan, mean was only calculated if there were a minimum of 3 participants and standard deviation was only calculated if there were a minimum of 4 participants.
Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 60	1.7 units on a scale Standard Deviation 3.7	-2.3 units on a scale Standard Deviation 8.5

SECONDARY outcome

Timeframe: Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60

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 indicates worsening and a negative change indicates improvement.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 9	-3.3 units on a scale Standard Deviation 3.8	-4.7 units on a scale Standard Deviation 4.3
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 13	-2.6 units on a scale Standard Deviation 4.2	-5.5 units on a scale Standard Deviation 4.4
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 5	-2.9 units on a scale Standard Deviation 4.7	-4.5 units on a scale Standard Deviation 4.4
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 7	-3.3 units on a scale Standard Deviation 4.4	-5.2 units on a scale Standard Deviation 4.3
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 17	-3.1 units on a scale Standard Deviation 4.9	-4.2 units on a scale Standard Deviation 4.4
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 21	-4.0 units on a scale Standard Deviation 4.7	-5.1 units on a scale Standard Deviation 4.9
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 25	-5.1 units on a scale Standard Deviation 4.6	-5.7 units on a scale Standard Deviation 5.5
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 29	-5.4 units on a scale Standard Deviation 3.6	-5.5 units on a scale Standard Deviation 6.3
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 33	-4.9 units on a scale Standard Deviation 4.8	-6.2 units on a scale Standard Deviation 5.7
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 37	-5.3 units on a scale Standard Deviation 3.9	-6.8 units on a scale Standard Deviation 5.9
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 41	-5.7 units on a scale Standard Deviation 4.3	-4.0 units on a scale Standard Deviation 3.1
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 45	-5.3 units on a scale Standard Deviation 2.8	-4.0 units on a scale Standard Deviation 3.5
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 49	-3.8 units on a scale Standard Deviation 0.8	-1.8 units on a scale Standard Deviation 1.8
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 52	-4.6 units on a scale Standard Deviation 2.9	NA units on a scale Standard Deviation NA NA signifies that as pre-specified in the Statistical Analysis Plan, mean was only calculated if there were a minimum of 3 participants and standard deviation was only calculated if there were a minimum of 4 participants.
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods Week 60	-0.9 units on a scale Standard Deviation 2.4	-1.8 units on a scale Standard Deviation 5.1

SECONDARY outcome

Timeframe: From Baseline until End of Study (up to Week 60)

Population: The Safety Set consisted of all randomized study participants who received at least 1 dose of IMP in this study.

Rescue therapy consisted of IVIg or PEX. Study participants who experienced disease worsening (eg, an increase of 2 points on the MG-ADL or 3 points on the QMG scale between 2 consecutive visits) may be considered for rescue therapy at the discretion of the Investigator.

Outcome measures

Outcome measures
Measure	Rozanolixizumab ~7 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=35 Participants Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Percentage of Participants Using Rescue Medication (Intravenous Infusion of Immunoglobulin G (IVIg) or Plasma Exchange (PEX))	11.4 percentage of participants	0 percentage of participants

Adverse Events

Rozanolixizumab ~7 mg/kg

Serious events: 7 serious events

Other events: 27 other events

Deaths: 0 deaths

Rozanolixizumab ~10 mg/kg

Serious events: 2 serious events

Other events: 25 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Rozanolixizumab ~7 mg/kg n=50 participants at risk Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=42 participants at risk Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Cardiac disorders Cardiac failure congestive	2.0% 1/50 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	0.00% 0/42 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Cardiac disorders Pericarditis	0.00% 0/50 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	2.4% 1/42 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Eye disorders Retinal detachment	2.0% 1/50 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	0.00% 0/42 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Investigations Biopsy kidney abnormal	2.0% 1/50 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	0.00% 0/42 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Musculoskeletal and connective tissue disorders Muscular weakness	2.0% 1/50 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	0.00% 0/42 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Nervous system disorders Myasthenia gravis	6.0% 3/50 • Number of events 4 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	2.4% 1/42 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.

Other adverse events

Other adverse events
Measure	Rozanolixizumab ~7 mg/kg n=50 participants at risk Participants received rozanolixizumab equivalent to approximately 7 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).	Rozanolixizumab ~10 mg/kg n=42 participants at risk Participants received rozanolixizumab equivalent to approximately 10 mg/kg, subcutaneously on a weekly basis over a 52-week Treatment Period. After 52-week Treatment Period, participants were followed up for 8 weeks (up to Week 60).
Gastrointestinal disorders Diarrhoea	12.0% 6/50 • Number of events 11 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	16.7% 7/42 • Number of events 10 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Gastrointestinal disorders Abdominal pain	4.0% 2/50 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	4.8% 2/42 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Gastrointestinal disorders Nausea	8.0% 4/50 • Number of events 4 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	11.9% 5/42 • Number of events 8 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Gastrointestinal disorders Vomiting	0.00% 0/50 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	9.5% 4/42 • Number of events 4 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
General disorders Pyrexia	8.0% 4/50 • Number of events 5 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	7.1% 3/42 • Number of events 4 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Immune system disorders Hypogammaglobulinaemia	4.0% 2/50 • Number of events 4 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	4.8% 2/42 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Infections and infestations Nasopharyngitis	4.0% 2/50 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	9.5% 4/42 • Number of events 4 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Infections and infestations Urinary tract infection	10.0% 5/50 • Number of events 5 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	4.8% 2/42 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Investigations Blood immunoglobulin G decreased	12.0% 6/50 • Number of events 12 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	11.9% 5/42 • Number of events 6 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Musculoskeletal and connective tissue disorders Back pain	4.0% 2/50 • Number of events 2 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	7.1% 3/42 • Number of events 3 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Nervous system disorders Headache	30.0% 15/50 • Number of events 55 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	28.6% 12/42 • Number of events 40 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Skin and subcutaneous tissue disorders Rash	2.0% 1/50 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	9.5% 4/42 • Number of events 7 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.
Vascular disorders Hypertension	6.0% 3/50 • Number of events 3 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.	2.4% 1/42 • Number of events 1 • From Baseline until End of Study (up to Week 60) TEAEs are reported in the safety section. TEAEs were planned to be analyzed using the SS by most recent dose received i.e. the most recent dose received at or before the AE onset. Participants who switched doses were counted in both RLZ doses.

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