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

Primary Purpose

Generalized Myasthenia Gravis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ravulizumab
Placebo
Sponsored by
Alexion
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Myasthenia Gravis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria.
  2. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening.
  3. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1).
  4. Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis).

Exclusion Criteria:

Medical Conditions

  1. Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening.
  2. History of thymectomy within the 12 months prior to screening.
  3. History of N meningitidis infection.

  4. Use of the following within the time period specified below:

    • IV immunoglobulin within 4 weeks of randomization
    • Use of plasma exchange within 4 weeks of randomization
    • Use of rituximab within 6 months of screening
  5. Participants who have received previous treatment with complement inhibitors (for example, eculizumab).

Sites / Locations

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Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Ravulizumab

Placebo

Arm Description

Participants will receive ravulizumab for the duration of the study.

Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.

Outcomes

Primary Outcome Measures

Change From Baseline In Myasthenia Gravis-Activities Of Daily Living (MG-ADL) Total Score At 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 Outcome Measures

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

Full Information

First Posted
April 16, 2019
Last Updated
August 16, 2023
Sponsor
Alexion
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1. Study Identification

Unique Protocol Identification Number
NCT03920293
Brief Title
Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis
Official Title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
March 26, 2019 (Actual)
Primary Completion Date
May 11, 2021 (Actual)
Study Completion Date
May 25, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Alexion

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab for the treatment of participants with generalized myasthenia gravis (gMG).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Masking Description
All investigative site personnel, sponsor staff, sponsor designees, staff directly associated with the conduct of the study, and all participants will be blinded to treatment assignments.
Allocation
Randomized
Enrollment
175 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ravulizumab
Arm Type
Experimental
Arm Description
Participants will receive ravulizumab for the duration of the study.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo during the 26-week randomized-controlled period of the study, after which they will enter the open-label extension period of the study and receive ravulizumab.
Intervention Type
Biological
Intervention Name(s)
Ravulizumab
Other Intervention Name(s)
ALXN1210, Ultomiris
Intervention Description
Concentrated sterile, preservative-free aqueous solution (10 milligrams [mg]/milliliter [mL]) in single-use, 30-mL vial for intravenous (IV) infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching, sterile, preservative-free aqueous solution in single-use, 30-mL vial for IV infusion. Single loading dose on Day 1, followed by regular maintenance dosing beginning on Day 15, based on weight.
Primary Outcome Measure Information:
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
Secondary Outcome Measure Information:
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
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
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
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
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosed with Myasthenia Gravis at least 6 months (180 days) prior to the date of the Screening Visit as confirmed by specific criteria. Myasthenia Gravis Foundation of America Clinical Classification Class II to IV at screening. MG-ADL profile must be ≥ 6 at screening and randomization (Day 1). Vaccinated against meningococcal infections within 3 years prior to, or at the time of, initiating study drug to reduce the risk of meningococcal infection (N meningitidis). Exclusion Criteria: Medical Conditions Any active or untreated thymoma. History of thymic carcinoma or thymic malignancy unless deemed cured by adequate treatment with no evidence of recurrence for ≥ 5 years before screening. History of thymectomy within the 12 months prior to screening. History of N meningitidis infection. Use of the following within the time period specified below: IV immunoglobulin within 4 weeks of randomization Use of plasma exchange within 4 weeks of randomization Use of rituximab within 6 months of screening Participants who have received previous treatment with complement inhibitors (for example, eculizumab).
Facility Information:
Facility Name
Clinical Trial Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85013-4409
Country
United States
Facility Name
Clinical Trial Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Clinical Trial Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85082
Country
United States
Facility Name
Clinical Trial Site
City
Loma Linda
State/Province
California
ZIP/Postal Code
92354
Country
United States
Facility Name
Clinical Trial Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
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United States
Facility Name
Clinical Trial Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
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United States
Facility Name
Clinical Trial Site
City
Palo Alto
State/Province
California
ZIP/Postal Code
94304
Country
United States
Facility Name
Clinical Trial Site
City
San Francisco
State/Province
California
ZIP/Postal Code
94109
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United States
Facility Name
Clinical Trial Site
City
Sylmar
State/Province
California
ZIP/Postal Code
91342
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United States
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Clinical Trial Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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United States
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Clinical Trial Site
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
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United States
Facility Name
Clinical Trial Site
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
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United States
Facility Name
Clinical Trial Site
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06510
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United States
Facility Name
Clinical Trial Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Clinical Trial Site
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33761
Country
United States
Facility Name
Clinical Trial Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Clinical Trial Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
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United States
Facility Name
Clinical Trial Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Clinical Trial Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Clinical Trial Site
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Clinical Trial Site
City
Rolling Meadows
State/Province
Illinois
ZIP/Postal Code
60008
Country
United States
Facility Name
Clinical Trial Site
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Clinical Trial Site
City
Fairway
State/Province
Kansas
ZIP/Postal Code
66205
Country
United States
Facility Name
Clinical Trial Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
Country
United States
Facility Name
Clinical Trial Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Facility Name
Clinical Trial Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Clinical Trial Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Clinical Trial Site
City
Burlington
State/Province
Massachusetts
ZIP/Postal Code
08013
Country
United States
Facility Name
Clinical Trial Site
City
East Lansing
State/Province
Michigan
ZIP/Postal Code
48824
Country
United States
Facility Name
Clinical Trial Site
City
Grand Rapids
State/Province
Michigan
ZIP/Postal Code
49503
Country
United States
Facility Name
Clinical Trial Site
City
Detroit Lakes
State/Province
Minnesota
ZIP/Postal Code
48201
Country
United States
Facility Name
Clinical Trial Site
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States
Facility Name
Clinical Trial Site
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Clinical Trial Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Clinical Trial Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89145
Country
United States
Facility Name
Clinical Trial Site
City
East Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Clinical Trial Site
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Clinical Trial Site
City
New York
State/Province
New York
ZIP/Postal Code
10075
Country
United States
Facility Name
Clinical Trial Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Clinical Trial Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Clinical Trial Site
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Clinical Trial Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Clinical Trial Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Clinical Trial Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Clinical Trial Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Clinical Trial Site
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43214
Country
United States
Facility Name
Clinical Trial Site
City
Springfield
State/Province
Oregon
ZIP/Postal Code
97499
Country
United States
Facility Name
Clinical Trial Site
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Clinical Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104-4206
Country
United States
Facility Name
Clinical Trial Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Clinical Trial Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29406
Country
United States
Facility Name
Clinical Trial Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29459
Country
United States
Facility Name
Clinical Trial Site
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Clinical Trial Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Clinical Trial Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78753
Country
United States
Facility Name
Clinical Trial Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75214
Country
United States
Facility Name
Clinical Trial Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Trial Site
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Clinical Trial Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Clinical Trial Site
City
Burlington
State/Province
Vermont
ZIP/Postal Code
05405
Country
United States
Facility Name
Clinical Trial Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Clinical Trial Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
Clinical Trial Site
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26506
Country
United States
Facility Name
Clinical Trial Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Clinical Trial Site
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Clinical Trial Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Clinical Trial Site
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Clinical Trial Site
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Clinical Trial Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Clinical Trial Site
City
Montreal
ZIP/Postal Code
H3A2B4
Country
Canada
Facility Name
Clinical Trial Site
City
Prague
State/Province
Czech Republic
ZIP/Postal Code
128 01
Country
Czechia
Facility Name
Clinical Trial Site
City
Ostrava
State/Province
Moravian-Silesian
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Clinical Trial Site
City
Brno
ZIP/Postal Code
62500
Country
Czechia
Facility Name
Clinical Trial Site
City
Prague
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Clinical Trial Site
City
Copenhagen
State/Province
Hovedstaden
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Clinical Trial Site
City
Aarhus N
State/Province
Jutland
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Clinical Trial Site
City
Aalborg
State/Province
North Jutland Region
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Clinical Trial Site
City
Lille
State/Province
Cedex
ZIP/Postal Code
59037
Country
France
Facility Name
Clinical Trial Site
City
Marseille
State/Province
Provence-Alpes-Cote d'Azur
ZIP/Postal Code
13385
Country
France
Facility Name
Clinical Trial Site
City
Nice
State/Province
Provence-Alpes-Cote d'Azur
ZIP/Postal Code
6000
Country
France
Facility Name
Clinical Trial Site
City
Garches
ZIP/Postal Code
92380
Country
France
Facility Name
Clinical Trial Site
City
Würzburg
State/Province
Bavaria
ZIP/Postal Code
97070
Country
Germany
Facility Name
Clinical Trial Site
City
Essen
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Clinical Trial Site
City
Münster
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48149
Country
Germany
Facility Name
Clinical Trial Site
City
Halle
State/Province
Sachsen-Anhalt
ZIP/Postal Code
6120
Country
Germany
Facility Name
Clinical Trial Site
City
Leipzig
State/Province
Saxony
ZIP/Postal Code
04103
Country
Germany
Facility Name
Clinical Trial Site
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Clinical Trial Site
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Clinical Trial Site
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Clinical Trial Site
City
Haifa
State/Province
Hefa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Clinical Trial Site
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Clinical Trial Site
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
Country
Italy
Facility Name
Clinical Trial Site
City
Genova
State/Province
Genoa
ZIP/Postal Code
16132
Country
Italy
Facility Name
Clinical Trial Site
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
Clinical Trial Site
City
Bergamo
State/Province
Roma
ZIP/Postal Code
24127
Country
Italy
Facility Name
Clinical Trial Site
City
Rome
State/Province
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Clinical Trial Site
City
Rome
State/Province
Roma
ZIP/Postal Code
00189
Country
Italy
Facility Name
Clinical Trial Site
City
Messina
State/Province
Sicilia
ZIP/Postal Code
98124
Country
Italy
Facility Name
Clinical Trial Site
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
466-8560
Country
Japan
Facility Name
Clinical Trial Site
City
Chuo Ku
State/Province
Chiba
ZIP/Postal Code
260-8677
Country
Japan
Facility Name
Clinical Trial Site
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Clinical Trial Site
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-8543
Country
Japan
Facility Name
Clinical Trial Site
City
Kanazawa-shi
State/Province
Ishikawa
ZIP/Postal Code
920-8641
Country
Japan
Facility Name
Clinical Trial Site
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
120-0047
Country
Japan
Facility Name
Clinical Trial Site
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
852-8501
Country
Japan
Facility Name
Clinical Trial Site
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Facility Name
Clinical Trial Site
City
Izumi-Shi
State/Province
Osaka
ZIP/Postal Code
594-0073
Country
Japan
Facility Name
Clinical Trial Site
City
Moriguchi-shi
State/Province
Osaka
ZIP/Postal Code
570-8507
Country
Japan
Facility Name
Clinical Trial Site
City
Osaka Sayama-shi
State/Province
Osaka
ZIP/Postal Code
5898511
Country
Japan
Facility Name
Clinical Trial Site
City
Suita-shi
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Clinical Trial Site
City
Toyonaka-shi
State/Province
Osaka
ZIP/Postal Code
560-8552
Country
Japan
Facility Name
Clinical Trial Site
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Clinical Trial Site
City
Sapporo-shi
State/Province
Sapporo
ZIP/Postal Code
0630005
Country
Japan
Facility Name
Clinical Trial Site
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8431
Country
Japan
Facility Name
Clinical Trial Site
City
Bunkyō-Ku
State/Province
Tokyo
ZIP/Postal Code
113-8655
Country
Japan
Facility Name
Clinical Trial Site
City
Shinjuku-Ku
State/Province
Tokyo
ZIP/Postal Code
160-8582
Country
Japan
Facility Name
Clinical Trial Site
City
Ube-shi
State/Province
Yamaguchi
ZIP/Postal Code
755-8505
Country
Japan
Facility Name
Clinical Trial Site
City
Hanamaki-shi
ZIP/Postal Code
025-0075
Country
Japan
Facility Name
Clinical Trial Site
City
Tokyo
ZIP/Postal Code
100-0001
Country
Japan
Facility Name
Clinical Trial Site
City
Yangsan
State/Province
Gyeongsangnam-do
ZIP/Postal Code
50612
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Daegu
ZIP/Postal Code
41404
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Seoul
ZIP/Postal Code
3080
Country
Korea, Republic of
Facility Name
Clinical Trial Site
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Clinical Trial Site
City
Leiden
State/Province
Noord-Holland
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
Clinical Trial Site
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Clinical Trial Site
City
Barakaldo
State/Province
Bizkaia
ZIP/Postal Code
48903
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
8025
Country
Spain
Facility Name
Clinical Trial Site
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Clinical Trial Site
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Facility Name
Clinical Trial Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Clinical Trial Site
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Clinical Trial Site
City
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Clinical Trial Site
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Clinical Trial Site
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Learn more about this trial

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

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