Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis

• ClinicalTrials.gov Identifier: NCT03920293
• Recruitment Status: Completed
• First Posted: April 18, 2019
• Results First Posted: May 26, 2022
• Last Update Posted: August 29, 2023
• Sponsor: Alexion Pharmaceuticals, Inc.
• Information provided by (Responsible Party): Alexion Pharmaceuticals, Inc.

• Study Type: Interventional
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Treatment
• Condition: Generalized Myasthenia Gravis
• Interventions: Biological: Ravulizumab; Drug: Placebo
• Enrollment: 175

Participant Flow

Recruitment Details
Pre-assignment Details	Participants were randomized 1:1 to either the ravulizumab or placebo group during the Randomized-Controlled Period. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.

Arm/Group Title	Randomized-Controlled Period: Ravulizumab	Randomized-Controlled Period: Placebo
Arm/Group Description	Participants received a weight-based single loading dose (2400 to 3000 milligrams [mg]) of ravulizumab intravenously (IV) on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 once every 8 weeks (q8w), during the 26-week Randomized-Controlled Period of the study.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study.
Period Title: Overall Study
Started	86	89
Received at Least 1 Dose of Study Drug	86	89
Completed	79	83
Not Completed	7	6
Reason Not Completed
Withdrawal by Subject	2	1
Physician Decision	1	2
Adverse Event	0	2
Sponsor Decision	0	1
Death	2	0
Protocol Violation	1	0
Noncompliance	1	0

Baseline Characteristics

Arm/Group Title		Ravulizumab	Placebo	Total
Arm/Group Description		Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Total of all reporting groups
Overall Number of Baseline Participants		86	89	175
Baseline Analysis Population Description		Full Analysis Set: All randomized participants who received at least 1 dose of study drug.
Age, Continuous; Mean (Standard Deviation); Unit of measure: Years
	Number Analyzed	86 participants	89 participants	175 participants
		58.0 (13.82)	53.3 (16.05)	55.6 (15.14)
Sex: Female, Male; Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	86 participants	89 participants	175 participants
	Female	44 51.2%	45 50.6%	89 50.9%
	Male	42 48.8%	44 49.4%	86 49.1%
Ethnicity (NIH/OMB); Measure Type: Count of Participants; Unit of measure: Participants
	Number Analyzed	86 participants	89 participants	175 participants
	Hispanic or Latino	2 2.3%	5 5.6%	7 4.0%
	Not Hispanic or Latino	79 91.9%	78 87.6%	157 89.7%
	Unknown or Not Reported	5 5.8%	6 6.7%	11 6.3%
Race/Ethnicity, Customized; Measure Type: Count of Participants; Unit of measure: Participants	Number Analyzed	86 participants	89 participants	175 participants
American Indian or Alaska Native		0 0.0%	1 1.1%	1 0.6%
Asian		15 17.4%	16 18.0%	31 17.7%
Native Hawaiian or Other Pacific Islander		0 0.0%	0 0.0%	0 0.0%
Black or African American		2 2.3%	4 4.5%	6 3.4%
White		67 77.9%	61 68.5%	128 73.1%
Other		0 0.0%	1 1.1%	1 0.6%
Unknown or Not Reported		2 2.3%	6 6.7%	8 4.6%

Outcome Measures

1. Primary Outcome

Title	Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26
Description	The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Estimates were based on Mixed Effect Repeated Measures (MMRM) that included treatment group, stratification factor region, and MG-ADL total score at baseline, study visit, and study visit by treatment group interaction.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Ravulizumab	Placebo
Arm/Group Description:	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
Overall Number of Participants Analyzed	86	89
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-3.1 (0.38)	-1.4 (0.37)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ravulizumab, Placebo
	Comments	[Not Specified]
	Type of Statistical Test	Superiority
	Comments	[Not Specified]
Statistical Test of Hypothesis	P-Value	=0.0009
	Comments	Statistical significance was tested at α=0.05.
	Method	MMRM
	Comments	[Not Specified]
Method of Estimation	Estimation Parameter	LS Mean Difference
	Estimated Value	-1.6
	Confidence Interval	(2-Sided) 95%; -2.6 to -0.7
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.49
	Estimation Comments	[Not Specified]

2. Secondary Outcome

Title	Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26
Description	The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. The QMG scoring system was considered to be an objective evaluation of therapy for MG and was based on quantitative testing of sentinel muscle groups. A decrease in score indicated improvement. Estimates were based on MMRM that included treatment group, stratification factor region, and QMG total score at baseline, study visit, and study visit by treatment group interaction.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Ravulizumab	Placebo
Arm/Group Description:	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
Overall Number of Participants Analyzed	86	89
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-2.8 (0.46)	-0.8 (0.45)

3. Secondary Outcome

Title	Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26
Description	The QMG scoring system consisted of 13 items: ocular (2 items), facial (1 item), bulbar (2 items), gross motor (6 items), axial (1 item), and respiratory (1 item); each graded 0 to 3, with 3 being the most severe. The range of total QMG score is 0 to 39. A decrease in score indicated improvement. Percentage of participants with a ≥5-point reduction in the QMG total score are reported. Estimates were based on a generalized linear mixed model (GLMM) that included treatment group, stratification factor region and QMG total score at baseline, study visit and study visit by treatment group interaction.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Ravulizumab	Placebo
Arm/Group Description:	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
Overall Number of Participants Analyzed	86	89
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	30.0; (19.2 to 43.5)	11.3; (5.6 to 21.5)

4. Secondary Outcome

Title	Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26
Description	The revised Myasthenia Gravis Qualify of Life 15-item scale (MG-QOL15r) is a health-related QoL evaluative instrument specific to participants with MG. The MG-QOL15r was designed to provide information about participants' perception of impairment and disability, determine the degree to which disease manifestations are tolerated, and to be administered and interpreted easily. Each item was graded on a scale of 0 to 2, with 2 being the most severe. The range of MG-QOL15r score is 0 to 30. Higher scores indicated greater extent of and dissatisfaction with MG-related dysfunction. Estimates are based on MMRM that included treatment group, stratification factor region and MG-QOL15r score at baseline, study visit and study visit by treatment group interaction.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Ravulizumab	Placebo
Arm/Group Description:	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
Overall Number of Participants Analyzed	86	89
Least Squares Mean (Standard Error); Unit of Measure: score on a scale
	-3.3 (0.71)	-1.6 (0.70)

5. Secondary Outcome

Title	Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26
Description	The Neuro-QOL Fatigue is a reliable and validated brief 19-item survey of fatigue, completed by the participant. Each items was rated on a scale of 1 to 5, with 5 being the most severe. The range of total score is 19 to 95. Higher scores indicated greater fatigue and greater impact of MG on activities. Estimates were based on MMRM that included treatment group, stratification factor region and Neuro-QoL Fatigue score at baseline, study visit, and study visit by treatment group interaction.
Time Frame	Baseline, Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Ravulizumab	Placebo
Arm/Group Description:	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
Overall Number of Participants Analyzed	86	89
Least Squares Mean (Standard Error); Unit of Measure: units on a scale
	-7.0 (1.92)	-4.8 (1.87)

6. Secondary Outcome

Title	Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26
Description	The MG-ADL is an 8-point questionnaire that focused on relevant symptoms and functional performance of activities of daily living in participants with MG. The 8 items of the MGADL questionnaire were derived from symptom-based components of the original 13-item QMG scale to assess disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item), and gross motor or limb (2 items) impairment related to effects from MG. In this functional status instrument, each response was graded 0 (normal) to 3 (most severe). The range of total MG-ADL score was 0 to 24. A decrease in score indicated improvement. Percentage of participants with a ≥3-point reduction in the MG-ADL total score are reported. Estimates were based on a GLMM that included treatment group, stratification factor region and MG-ADL total score at baseline, study visit and study visit by treatment group interaction.
Time Frame	Week 26

Outcome Measure Data

Analysis Population Description

Full Analysis Set: All randomized participants who received at least 1 dose of study drug.

Arm/Group Title	Ravulizumab	Placebo
Arm/Group Description:	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.	Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
Overall Number of Participants Analyzed	86	89
Measure Type: Number; Number (95% Confidence Interval); Unit of Measure: percentage of participants
	56.7; (44.3 to 68.3)	34.1; (23.8 to 46.1)

Adverse Events

Time Frame	Day 1 (after dosing) through Week 26
Adverse Event Reporting Description	Treatment-emergent adverse events reported during the 26-week randomized-controlled period of the study are presented. The Open-Label Extension Period is ongoing, and results will be presented when the study is completed.
Arm/Group Title	Randomized-Controlled Period: Ravulizumab		Randomized-Controlled Period: Placebo
Arm/Group Description	Participants received a weight-based single loading dose (2400 to 3000 mg) of ravulizumab IV on Day 1, followed by regular maintenance IV weight-based doses (3000 to 3600 mg) of ravulizumab beginning on Day 15 q8w during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.		Participants received a weight-based single loading dose of placebo IV on Day 1, followed by regular maintenance IV weight-based doses of placebo beginning on Day 15 q8w, during the 26-week Randomized-Controlled Period of the study. Following the placebo-controlled part of the study, participants were transitioned to the ongoing Open-Label Extension Period to receive treatment with ravulizumab.
All-Cause Mortality
	Randomized-Controlled Period: Ravulizumab		Randomized-Controlled Period: Placebo
	Affected / at Risk (%)		Affected / at Risk (%)
Total	2/86 (2.33%)		0/89 (0.00%)
Serious Adverse Events
	Randomized-Controlled Period: Ravulizumab		Randomized-Controlled Period: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	20/86 (23.26%)		14/89 (15.73%)
Cardiac disorders
Congestive cardiomyopathy † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Eye disorders
Visual impairment † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Gastrointestinal disorders
Dysphagia † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Nausea † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Enteritis † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
General disorders
Asthenia † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
General physical health deterioration † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Non-cardiac chest pain † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Infections and infestations
COVID-19 pneumonia † 1	2/86 (2.33%)	3	0/89 (0.00%)	0
Arthritis bacterial † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Diverticulitis † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Gangrene † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Gastroenteritis viral † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Herpes zoster † 1	1/86 (1.16%)	1	1/89 (1.12%)	1
Infected skin ulcer † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Pneumonia respiratory syncytial viral † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Staphylococcal sepsis † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
COVID-19 † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Cellulitis † 1	0/86 (0.00%)	0	2/89 (2.25%)	2
Injury, poisoning and procedural complications
Multiple fractures † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Infusion-related reaction † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Metabolism and nutrition disorders
Steroid diabetes † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Diabetic ketoacidosis † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Nodal osteoarthritis † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Tendonitis † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Spinal stenosis † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Ureteral neoplasm † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Nervous system disorders
Transient ischaemic attack † 1	2/86 (2.33%)	2	0/89 (0.00%)	0
Cerebral haemorrhage † 1	1/86 (1.16%)	2	0/89 (0.00%)	0
Myasthenia gravis crisis † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Syncope † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Facial paresis † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Myasthenia gravis † 1	0/86 (0.00%)	0	3/89 (3.37%)	3
Trigeminal neuralgia † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Psychiatric disorders
Suicide attempt † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Renal and urinary disorders
Nephrotic syndrome † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Renal failure † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
Respiratory, thoracic and mediastinal disorders
Dyspnoea † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Dyspnoea exertional † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Lung infiltration † 1	1/86 (1.16%)	1	0/89 (0.00%)	0
Skin and subcutaneous tissue disorders
Granuloma skin † 1	0/86 (0.00%)	0	1/89 (1.12%)	1
1 Term from vocabulary, MedDRA 24.0; † Indicates events were collected by systematic assessment
Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events	5%
	Randomized-Controlled Period: Ravulizumab		Randomized-Controlled Period: Placebo
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	77/86 (89.53%)		75/89 (84.27%)
Gastrointestinal disorders
Diarrhoea † 1	13/86 (15.12%)	14	11/89 (12.36%)	15
Nausea † 1	9/86 (10.47%)	12	9/89 (10.11%)	10
Abdominal pain † 1	5/86 (5.81%)	6	0/89 (0.00%)	0
General disorders
Fatigue † 1	6/86 (6.98%)	7	6/89 (6.74%)	6
Pyrexia † 1	1/86 (1.16%)	1	5/89 (5.62%)	6
Infections and infestations
COVID-19 † 1	5/86 (5.81%)	5	3/89 (3.37%)	3
Urinary tract infection † 1	5/86 (5.81%)	7	4/89 (4.49%)	5
Nasopharyngitis † 1	3/86 (3.49%)	3	5/89 (5.62%)	7
Musculoskeletal and connective tissue disorders
Back pain † 1	7/86 (8.14%)	7	5/89 (5.62%)	5
Arthralgia † 1	6/86 (6.98%)	8	7/89 (7.87%)	8
Nervous system disorders
Headache † 1	16/86 (18.60%)	19	23/89 (25.84%)	27
Dizziness † 1	8/86 (9.30%)	9	3/89 (3.37%)	3
1 Term from vocabulary, MedDRA 24.0; † Indicates events were collected by 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

• Name/Title: Alexion Pharmaceuticals Inc.
• Organization: Alexion Pharmaceuticals Inc.
• Phone: +1 855-752-2356
• EMail: clinicaltrials@alexion.com

• Responsible Party: Alexion Pharmaceuticals, Inc.
• ClinicalTrials.gov Identifier: NCT03920293
• Other Study ID Numbers: ALXN1210-MG-306; 2018-003243-39 ( EudraCT Number )
• First Submitted: April 16, 2019
• First Posted: April 18, 2019
• Results First Submitted: May 3, 2022
• Results First Posted: May 26, 2022
• Last Update Posted: August 29, 2023