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

Study Type	Interventional
Study Design	Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
Condition	Generalized Myasthenia Gravis
Intervention	Drug: Rozanolixizumab
Enrollment	71

Participant Flow

Recruitment Details	The study started to enroll study participants in Oct 2019 and concluded in Sep 2021.
Pre-assignment Details	Participant Flow refers to the Randomized Set.


Arm/Group Title	Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description	Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description	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).	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).
Period Title: Overall Study
Started	35	36
Safety Set ^[1]	35	35
Completed	5	3
Not Completed	30	33
Reason Not Completed
Adverse event, non-fatal	3	1
Withdrawal by Subject	1	1
Rolled Over To MG0007 Study	25	28
Pregnancy	1	0
Sponsor and participant decision	0	1
Personal surgery	0	1
Physician Decision	0	1
[1] Received at least 1 dose of investigational medicinal product

Baseline Characteristics

Arm/Group Title		Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg	Total
Arm/Group Description		Participants received rozanolixizum...	Participants received rozanolixizum...	Total of all reporting groups
Arm/Group Description		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).	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 of all reporting groups
Overall Number of Baseline Participants		35	36	71
Baseline Analysis Population Description		...
Baseline Analysis Population Description		Baseline Characteristics refer to the Randomized Set (RS) which consisted of all study participants who were randomized, using the treatment assigned instead of the actual treatment received.
Age, Categorical Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	36 participants	71 participants
	<=18 years	0 0.0%	0 0.0%	0 0.0%
	Between 18 and 65 years	29 82.9%	26 72.2%	55 77.5%
	>=65 years	6 17.1%	10 27.8%	16 22.5%
Age, Continuous Mean (Standard Deviation) Unit of measure: Years
	Number Analyzed	35 participants	36 participants	71 participants
		50.6 (14.2)	53.7 (17.2)	52.2 (15.8)
Sex: Female, Male Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	36 participants	71 participants
	Female	19 54.3%	19 52.8%	38 53.5%
	Male	16 45.7%	17 47.2%	33 46.5%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	36 participants	71 participants
	Asian	4 11.4%	4 11.1%	8 11.3%
	Black	2 5.7%	3 8.3%	5 7.0%
	White	17 48.6%	19 52.8%	36 50.7%
	Missing	12 34.3%	10 27.8%	22 31.0%
Race/Ethnicity, Customized Measure Type: Count of Participants Unit of measure: Participants
	Number Analyzed	35 participants	36 participants	71 participants
	Hispanic or Latino	4 11.4%	2 5.6%	6 8.5%
	Not Hispanic or Latino	19 54.3%	25 69.4%	44 62.0%
	Missing	12 34.3%	9 25.0%	21 29.6%

Outcome Measures

1.Primary Outcome


Title	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs)
Description	A TEAE is defined as an AE starting on or after the time of first admi...
Description	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.
Time Frame	From Baseline until End of Study (up to Week 60)

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description:	Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description:	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).	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 Number of Participants Analyzed	50	42
Measure Type: Number Unit of Measure: percentage of participants
	76.0	78.6

2.Primary Outcome


Title	Percentage of Participants With Treatment-emergent Adverse Events (TEAEs) Leading to Permanent Withdrawal of Study Medication
Description	A TEAE is defined as an AE starting on or after the time of first admi...
Description	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.
Time Frame	From Baseline until End of Study (up to Week 60)

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title	Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description:	Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description:	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).	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 Number of Participants Analyzed	50	42
Measure Type: Number Unit of Measure: percentage of participants
	6.0	0

3.Secondary Outcome


Title	Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Each Scheduled Assessment During Treatment and Observation Periods
Description	The Myasthenia Gravis Activities of Daily Living (MG-ADL) is an 8-item...
Description	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.
Time Frame	Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title		Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description:		Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description:		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).	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 Number of Participants Analyzed		35	35
Mean (Standard Deviation) Unit of Measure: units on a scale
Week 5	Number Analyzed	34 participants	34 participants
Week 5		-2.7 (3.3)	-3.2 (3.8)
Week 7	Number Analyzed	35 participants	32 participants
Week 7		-2.7 (3.8)	-3.7 (3.4)
Week 9	Number Analyzed	29 participants	31 participants
Week 9		-2.8 (3.4)	-3.4 (3.7)
Week 13	Number Analyzed	30 participants	30 participants
Week 13		-3.1 (3.4)	-3.9 (4.0)
Week 17	Number Analyzed	25 participants	29 participants
Week 17		-2.8 (3.3)	-4.0 (3.9)
Week 21	Number Analyzed	20 participants	24 participants
Week 21		-3.0 (3.4)	-4.1 (4.3)
Week 25	Number Analyzed	18 participants	17 participants
Week 25		-2.7 (3.0)	-3.7 (4.7)
Week 29	Number Analyzed	13 participants	14 participants
Week 29		-2.8 (2.1)	-3.6 (4.3)
Week 33	Number Analyzed	10 participants	12 participants
Week 33		-3.0 (2.8)	-3.5 (4.5)
Week 37	Number Analyzed	7 participants	10 participants
Week 37		-3.9 (2.5)	-3.6 (3.6)
Week 41	Number Analyzed	6 participants	6 participants
Week 41		-2.8 (2.1)	-1.8 (1.0)
Week 45	Number Analyzed	4 participants	7 participants
Week 45		-3.8 (2.4)	-2.1 (1.1)
Week 49	Number Analyzed	5 participants	6 participants
Week 49		-2.4 (1.1)	-0.5 (3.7)
Week 52	Number Analyzed	5 participants	3 participants
Week 52		-2.6 (1.3)	-2.0 ^[1] (NA)
Week 60	Number Analyzed	7 participants	7 participants
Week 60		-0.3 (2.1)	-1.3 (3.9)

[1]

NA signifies that as pre-specified in the Statistical Analysis Plan, Standard Deviation was only calculated if there were a minimum of 4 participants.

4.Secondary Outcome


Title	Change From Baseline in Myasthenia Gravis-Composite (MG-C) Total Score at Each Scheduled Assessment During Treatment and Observation Periods
Description	MG-C scale is a validated assessment and scale tests 10 items with ind...
Description	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.
Time Frame	Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title		Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description:		Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description:		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).	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 Number of Participants Analyzed		35	35
Mean (Standard Deviation) Unit of Measure: units on a scale
Week 5	Number Analyzed	34 participants	35 participants
Week 5		-4.7 (5.5)	-5.5 (7.3)
Week 7	Number Analyzed	35 participants	33 participants
Week 7		-5.0 (5.7)	-7.1 (7.4)
Week 9	Number Analyzed	29 participants	30 participants
Week 9		-5.0 (5.3)	-6.0 (7.4)
Week 13	Number Analyzed	30 participants	30 participants
Week 13		-4.8 (5.5)	-7.0 (7.8)
Week 17	Number Analyzed	25 participants	29 participants
Week 17		-4.4 (5.7)	-5.5 (8.6)
Week 21	Number Analyzed	20 participants	24 participants
Week 21		-5.3 (6.9)	-7.3 (8.1)
Week 25	Number Analyzed	18 participants	17 participants
Week 25		-6.1 (5.8)	-8.8 (7.7)
Week 29	Number Analyzed	13 participants	14 participants
Week 29		-5.1 (5.5)	-9.1 (9.2)
Week 33	Number Analyzed	9 participants	12 participants
Week 33		-4.6 (5.1)	-8.4 (8.6)
Week 37	Number Analyzed	7 participants	10 participants
Week 37		-6.3 (6.8)	-8.6 (6.9)
Week 41	Number Analyzed	6 participants	6 participants
Week 41		-6.0 (7.1)	-6.5 (5.8)
Week 45	Number Analyzed	4 participants	7 participants
Week 45		-4.0 (6.2)	-5.3 (4.9)
Week 49	Number Analyzed	5 participants	6 participants
Week 49		-1.4 (3.8)	-0.8 (9.2)
Week 52	Number Analyzed	5 participants	2 participants
Week 52		-3.8 (3.1)	NA ^[1] (NA)
Week 60	Number Analyzed	7 participants	7 participants
Week 60		1.7 (3.7)	-2.3 (8.5)

[1]

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.

5.Secondary Outcome


Title	Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Each Scheduled Assessment During Treatment and Observation Periods
Description	The QMG is a validated assessment and the scale tested 13 items, inclu...
Description	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.
Time Frame	Baseline, Weeks 5, 7, 9, 13, 17, 21, 25, 29, 33, 37, 41, 45, 49, 52 and 60

Outcome Measure Data

Analysis Population Description

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.


Arm/Group Title		Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description:		Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description:		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).	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 Number of Participants Analyzed		35	35
Mean (Standard Deviation) Unit of Measure: units on a scale
Week 5	Number Analyzed	34 participants	34 participants
Week 5		-2.9 (4.7)	-4.5 (4.4)
Week 7	Number Analyzed	35 participants	32 participants
Week 7		-3.3 (4.4)	-5.2 (4.3)
Week 9	Number Analyzed	28 participants	30 participants
Week 9		-3.3 (3.8)	-4.7 (4.3)
Week 13	Number Analyzed	30 participants	29 participants
Week 13		-2.6 (4.2)	-5.5 (4.4)
Week 17	Number Analyzed	25 participants	28 participants
Week 17		-3.1 (4.9)	-4.2 (4.4)
Week 21	Number Analyzed	20 participants	23 participants
Week 21		-4.0 (4.7)	-5.1 (4.9)
Week 25	Number Analyzed	18 participants	16 participants
Week 25		-5.1 (4.6)	-5.7 (5.5)
Week 29	Number Analyzed	13 participants	13 participants
Week 29		-5.4 (3.6)	-5.5 (6.3)
Week 33	Number Analyzed	10 participants	11 participants
Week 33		-4.9 (4.8)	-6.2 (5.7)
Week 37	Number Analyzed	7 participants	9 participants
Week 37		-5.3 (3.9)	-6.8 (5.9)
Week 41	Number Analyzed	6 participants	5 participants
Week 41		-5.7 (4.3)	-4.0 (3.1)
Week 45	Number Analyzed	4 participants	6 participants
Week 45		-5.3 (2.8)	-4.0 (3.5)
Week 49	Number Analyzed	5 participants	5 participants
Week 49		-3.8 (0.8)	-1.8 (1.8)
Week 52	Number Analyzed	5 participants	2 participants
Week 52		-4.6 (2.9)	NA ^[1] (NA)
Week 60	Number Analyzed	7 participants	6 participants
Week 60		-0.9 (2.4)	-1.8 (5.1)

[1]

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.

6.Secondary Outcome


Title	Percentage of Participants Using Rescue Medication (Intravenous Infusion of Immunoglobulin G (IVIg) or Plasma Exchange (PEX))
Description	Rescue therapy consisted of IVIg or PEX. Study participants who experi...
Description	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.
Time Frame	From Baseline until End of Study (up to Week 60)

Outcome Measure Data

Analysis Population Description

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


Arm/Group Title	Rozanolixizumab ~7 mg/kg	Rozanolixizumab ~10 mg/kg
Arm/Group Description:	Participants received rozanolixizum...	Participants received rozanolixizum...
Arm/Group Description:	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).	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 Number of Participants Analyzed	35	35
Measure Type: Number Unit of Measure: percentage of participants
	11.4	0

Adverse Events

Time Frame	From Baseline until End of Study (up to Week 60)
Adverse Event Reporting Description	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.

Arm/Group Title	Rozanolixizumab ~7 mg/kg		Rozanolixizumab ~10 mg/kg
Arm/Group Description	Participants received rozanolixizum...		Participants received rozanolixizum...
Arm/Group Description	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).		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).
All-Cause Mortality
	Rozanolixizumab ~7 mg/kg		Rozanolixizumab ~10 mg/kg
	Affected / at Risk (%)		Affected / at Risk (%)
Total	0/50 (0.00%)		0/42 (0.00%)
Serious Adverse Events Serious Adverse Events
	Rozanolixizumab ~7 mg/kg		Rozanolixizumab ~10 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	7/50 (14.00%)		2/42 (4.76%)
Cardiac disorders
Cardiac failure congestive ^* 1	1/50 (2.00%)	2	0/42 (0.00%)	0
Pericarditis ^* 1	0/50 (0.00%)	0	1/42 (2.38%)	1
Eye disorders
Retinal detachment ^* 1	1/50 (2.00%)	1	0/42 (0.00%)	0
Investigations
Biopsy kidney abnormal ^* 1	1/50 (2.00%)	1	0/42 (0.00%)	0
Musculoskeletal and connective tissue disorders
Muscular weakness ^* 1	1/50 (2.00%)	1	0/42 (0.00%)	0
Nervous system disorders
Myasthenia gravis ^* 1	3/50 (6.00%)	4	1/42 (2.38%)	1
1 Term from vocabulary, MedDRA 24.0 * Indicates events were collected by non-systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Rozanolixizumab ~7 mg/kg		Rozanolixizumab ~10 mg/kg
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	27/50 (54.00%)		25/42 (59.52%)
Gastrointestinal disorders
Diarrhoea ^* 1	6/50 (12.00%)	11	7/42 (16.67%)	10
Abdominal pain ^* 1	2/50 (4.00%)	2	2/42 (4.76%)	2
Nausea ^* 1	4/50 (8.00%)	4	5/42 (11.90%)	8
Vomiting ^* 1	0/50 (0.00%)	0	4/42 (9.52%)	4
General disorders
Pyrexia ^* 1	4/50 (8.00%)	5	3/42 (7.14%)	4
Immune system disorders
Hypogammaglobulinaemia ^* 1	2/50 (4.00%)	4	2/42 (4.76%)	2
Infections and infestations
Nasopharyngitis ^* 1	2/50 (4.00%)	2	4/42 (9.52%)	4
Urinary tract infection ^* 1	5/50 (10.00%)	5	2/42 (4.76%)	2
Investigations
Blood immunoglobulin G decreased ^* 1	6/50 (12.00%)	12	5/42 (11.90%)	6
Musculoskeletal and connective tissue disorders
Back pain ^* 1	2/50 (4.00%)	2	3/42 (7.14%)	3
Nervous system disorders
Headache ^* 1	15/50 (30.00%)	55	12/42 (28.57%)	40
Skin and subcutaneous tissue disorders
Rash ^* 1	1/50 (2.00%)	1	4/42 (9.52%)	7
Vascular disorders
Hypertension ^* 1	3/50 (6.00%)	3	1/42 (2.38%)	1
1 Term from vocabulary, MedDRA 24.0 * Indicates events were collected by non-systematic assessment

Limitations and Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Layout table for Results Point of Contact information

Name/Title:	UCB
Organization:	Cares
Phone:	001 844 599 2273
EMail:	UCBCares@ucb.com

Layout table for additonal information

Responsible Party:	UCB Pharma ( UCB Biopharma SRL )
ClinicalTrials.gov Identifier:	NCT04124965
Other Study ID Numbers:	MG0004 2019-000969-21 ( EudraCT Number )
First Submitted:	October 11, 2019
First Posted:	October 14, 2019
Results First Submitted:	July 27, 2023
Results First Posted:	August 21, 2023
Last Update Posted:	September 5, 2023