Trial · NCT03920293

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

NCT03920293, Phase 3, Completed, Alexion Pharmaceuticals, Inc.; results first posted 2022-05-26

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis. Trials, record NCT03920293. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03920293

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
NCT number: NCT03920293
Status: Completed
Phases: Phase 3
Enrollment: 175 participants, actual
Lead sponsor: Alexion Pharmaceuticals, Inc.
Conditions: Generalized Myasthenia Gravis
Interventions: Ravulizumab, Placebo
First posted: 2019-04-18
Last updated: 2024-05-28
Other registries' IDs: eudract:2018-003243-39
Results first posted: 2022-05-26

Source ClinicalTrials.gov

Registered outcomes6

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

List	Outcome	Time frame	Description
Primary	Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26	Baseline, Week 26	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.
Secondary	Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26	Baseline, Week 26	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.
Secondary	Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26	Week 26	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.
Secondary	Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26	Baseline, Week 26	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.
Secondary	Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26	Baseline, Week 26	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.
Secondary	Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26	Week 26	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.

Source ClinicalTrials.gov

Outcomes6

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26	Baseline, Week 26	Full Analysis Set: All randomized participants who received at least 1 dose of study drug.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26	Baseline, Week 26	Full Analysis Set: All randomized participants who received at least 1 dose of study drug.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26	Week 26	Full Analysis Set: All randomized participants who received at least 1 dose of study drug.	percentage of participants	NUMBER
SECONDARY	Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26	Baseline, Week 26	Full Analysis Set: All randomized participants who received at least 1 dose of study drug.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26	Baseline, Week 26	Full Analysis Set: All randomized participants who received at least 1 dose of study drug.	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Percentage of Participants With a Myasthenia Gravis Activities of Daily Living (MG-ADL) Total Score Reduction of at Least 3 Points At Week 26	Week 26	Full Analysis Set: All randomized participants who received at least 1 dose of study drug.	percentage of participants	NUMBER

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26	Ravulizumab	-3.1	Standard Error 0.38	units on a scale
Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At Week 26	Placebo	-1.4	Standard Error 0.37	units on a scale
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26	Ravulizumab	-2.8	Standard Error 0.46	units on a scale
Change From Baseline In The Quantitative Myasthenia Gravis (QMG) Total Score At Week 26	Placebo	-0.8	Standard Error 0.45	units on a scale
Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26	Ravulizumab	30.0	95% Confidence Interval 19.2 to 43.5	percentage of participants
Percentage of Participants With a Quantitative Myasthenia Gravis (QMG) Total Score Reduction of at Least 5 Points At Week 26	Placebo	11.3	95% Confidence Interval 5.6 to 21.5	percentage of participants
Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26	Ravulizumab	-3.3	Standard Error 0.71	score on a scale
Change From Baseline In the Revised 15 Component Myasthenia Gravis Quality of Life (MG-QOL15r) At Week 26	Placebo	-1.6	Standard Error 0.70	score on a scale
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26	Ravulizumab	-7.0	Standard Error 1.92	units on a scale
Change From Baseline in Neurological Quality of Life (Neuro-QoL) Fatigue Score at Week 26	Placebo	-4.8	Standard Error 1.87	units on a scale

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow14

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Randomized-Controlled Period	STARTED	Ravulizumab to Ravulizumab	86
Randomized-Controlled Period	STARTED	Placebo to Ravulizumab	89
Randomized-Controlled Period	Received at Least 1 Dose of Study Drug	Ravulizumab to Ravulizumab	86
Randomized-Controlled Period	Received at Least 1 Dose of Study Drug	Placebo to Ravulizumab	89
Randomized-Controlled Period	COMPLETED	Ravulizumab to Ravulizumab	79
Randomized-Controlled Period	COMPLETED	Placebo to Ravulizumab	83
Randomized-Controlled Period	NOT COMPLETED	Ravulizumab to Ravulizumab	7
Randomized-Controlled Period	NOT COMPLETED	Placebo to Ravulizumab	6
Open- Label Extension Period	STARTED	Ravulizumab to Ravulizumab	78
Open- Label Extension Period	STARTED	Placebo to Ravulizumab	83

1 to 10 of 14Source ClinicalTrials.gov

See all 14 participant flow

Adverse events604

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	COVID-19	Infections and infestations	Randomized-Controlled Period: Ravulizumab	5	86	5
other	COVID-19	Infections and infestations	Randomized-Controlled Period: Placebo	3	89	3
other	COVID-19	Infections and infestations	Open-Label Extension Period: Placebo to Ravulizumab	26	83	28
other	COVID-19	Infections and infestations	Open-Label Extension Period: Ravulizumab to Ravulizumab	30	78	32
other	Urinary tract infection	Infections and infestations	Randomized-Controlled Period: Ravulizumab	5	86	7
other	Urinary tract infection	Infections and infestations	Randomized-Controlled Period: Placebo	4	89	5
other	Urinary tract infection	Infections and infestations	Open-Label Extension Period: Placebo to Ravulizumab	8	83	13
other	Urinary tract infection	Infections and infestations	Open-Label Extension Period: Ravulizumab to Ravulizumab	7	78	9
other	Nasopharyngitis	Infections and infestations	Randomized-Controlled Period: Ravulizumab	3	86	3
other	Nasopharyngitis	Infections and infestations	Randomized-Controlled Period: Placebo	5	89	7

1 to 10 of 604Source ClinicalTrials.gov

See all 604 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Randomized-Controlled Period: Ravulizumab	2	86
Total, all-cause mortality	Randomized-Controlled Period: Placebo	0	89
Total, all-cause mortality	Open-Label Extension Period: Placebo to Ravulizumab	3	83
Total, all-cause mortality	Open-Label Extension Period: Ravulizumab to Ravulizumab	3	78
Total, other adverse events	Randomized-Controlled Period: Ravulizumab	77	86
Total, other adverse events	Randomized-Controlled Period: Placebo	75	89
Total, other adverse events	Open-Label Extension Period: Placebo to Ravulizumab	79	83
Total, other adverse events	Open-Label Extension Period: Ravulizumab to Ravulizumab	77	78
Total, serious adverse events	Randomized-Controlled Period: Ravulizumab	20	86
Total, serious adverse events	Randomized-Controlled Period: Placebo	14	89

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers4

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
36852670	DERIVED	PubMed
36890354	DERIVED	PubMed
37103755	DERIVED	PubMed
38319212	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

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

Each source's terms

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

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

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03920293

GET https://conductscience.org/api/trials/v1/NCT03920293/events?page=2

API reference For AI assistants