Back to resultsSafety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Primary Purpose
Generalized Myasthenia Gravis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
ALXN1720
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Myasthenia Gravis focused on measuring ALXN1720, anti-acetylcholine receptor antibody-positive, acetylcholine receptor, AChR, generalized myasthenia gravis, myasthenia gravis, MG, gMG, complement component 5, C5, VHH antibody
Eligibility Criteria
Inclusion Criteria:
- Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
- Positive serological test for autoantibodies against AChR.
Exclusion Criteria:
- History of thymectomy or any other thymic surgery within 12 months prior to Screening
- Untreated thymic malignancy, carcinoma, or thymoma
- History of Neisseria meningitidis infection
- Pregnancy, breastfeeding, or intention to conceive during the course of the study.
Sites / Locations
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Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ALXN1720
Placebo
Arm Description
Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks.
Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.
Outcomes
Primary Outcome Measures
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26
Secondary Outcome Measures
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26
Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26
Response defined as reduction of the MG-ADL total score by >= 3 points from baseline at Week 26.
Percentage of Responders based on Reduction of the QMG Total Score at Week 26
Response defined as reduction of the QMG total score by >= 5 points from baseline at Week 26
Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05556096
Brief Title
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel, Multicenter Study to Evaluate the Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 21, 2022 (Actual)
Primary Completion Date
August 5, 2025 (Anticipated)
Study Completion Date
July 7, 2027 (Anticipated)
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
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of ALXN1720 for the treatment of generalized MG (gMG) in adults with autoantibodies against acetylcholine receptor (AChR).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Myasthenia Gravis
Keywords
ALXN1720, anti-acetylcholine receptor antibody-positive, acetylcholine receptor, AChR, generalized myasthenia gravis, myasthenia gravis, MG, gMG, complement component 5, C5, VHH antibody
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
This is a treatment study with 2 parallel intervention groups. The study is blinded for sponsor staff, sponsor designees, investigative site personnel, other staff directly associated with the conduct of the study, and study participants.
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
254 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
ALXN1720
Arm Type
Experimental
Arm Description
Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.
Intervention Type
Combination Product
Intervention Name(s)
ALXN1720
Intervention Description
Combination product consisting of syringe prefilled with ALXN1720.
Intervention Type
Combination Product
Intervention Name(s)
Placebo
Intervention Description
Combination product consisting of syringe prefilled with placebo.
Primary Outcome Measure Information:
Title
Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26
Time Frame
Baseline, Week 26
Secondary Outcome Measure Information:
Title
Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26
Time Frame
Baseline, Week 26
Title
Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26
Description
Response defined as reduction of the MG-ADL total score by >= 3 points from baseline at Week 26.
Time Frame
Baseline up to Week 26
Title
Percentage of Responders based on Reduction of the QMG Total Score at Week 26
Description
Response defined as reduction of the QMG total score by >= 5 points from baseline at Week 26
Time Frame
Baseline up to Week 26
Title
Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26
Time Frame
Baseline, Week 26
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV
Positive serological test for autoantibodies against AChR
Exclusion Criteria:
History of thymectomy, or any other thymic surgery within 12 months prior to Screening
Untreated thymic malignancy, carcinoma, or thymoma
History of Neisseria meningitidis infection
Pregnancy, breastfeeding, or intention to conceive during the course of the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
AstraZeneca Clinical Study Information Center
Phone
1-877-240-9479
Email
information.center@astrazeneca.com
Facility Information:
Facility Name
Research Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34209
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Gainesville
State/Province
Georgia
ZIP/Postal Code
30501
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62769
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Individual Site Status
Recruiting
Facility Name
Research Site
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40503
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United States
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Recruiting
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City
Detroit
State/Province
Michigan
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48202
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United States
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Recruiting
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East Lansing
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Michigan
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48824
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United States
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Las Vegas
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Nevada
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89145
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United States
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Recruiting
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City
Patchogue
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New York
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11772
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United States
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Recruiting
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Syracuse
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New York
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13202
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United States
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Chapel Hill
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North Carolina
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27599
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United States
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Portland
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Oregon
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97239
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United States
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North Charleston
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South Carolina
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29406
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United States
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Richmond
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Virginia
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23298
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United States
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City
Seattle
State/Province
Washington
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98122
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United States
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City
Morgantown
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West Virginia
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26506
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United States
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Buenos Aires
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1015
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Argentina
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Caba
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1181
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Argentina
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Caba
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C1192AAW
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Argentina
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Recruiting
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City
Capital Federal
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C1428AQK
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Argentina
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Not yet recruiting
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Rosario
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S2000BZL
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Argentina
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Innsbruck
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Austria
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Wels-Grieskirchen
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Barretos
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Joinville
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89202-190
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Porto Alegre
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90110-000
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Brazil
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City
Ribeirão Preto
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14049-901
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Brazil
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Salvador
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41253-190
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Brazil
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Sao Jose Do Rio Preto
ZIP/Postal Code
15090-000
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Brazil
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City
Sao Paulo
ZIP/Postal Code
05403-000
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Brazil
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City
London
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Ontario
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N6A 5A5
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Canada
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Recruiting
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City
Montreal
State/Province
Quebec
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H4A 3TA
Country
Canada
Individual Site Status
Recruiting
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City
Beijing
ZIP/Postal Code
100034
Country
China
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Not yet recruiting
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City
Aalborg
ZIP/Postal Code
9000
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Denmark
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Recruiting
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City
København Ø
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2100
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Denmark
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City
Angers
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49033
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France
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City
Garches
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92380
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France
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City
Lille
ZIP/Postal Code
59037
Country
France
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Recruiting
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City
Marseille
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13385
Country
France
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Recruiting
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City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
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City
Nice
ZIP/Postal Code
06000
Country
France
Individual Site Status
Recruiting
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City
Paris Cedex 13
ZIP/Postal Code
75651
Country
France
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Recruiting
Facility Name
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City
Strasbourg Cedex
ZIP/Postal Code
67098
Country
France
Individual Site Status
Recruiting
Facility Name
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City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Individual Site Status
Recruiting
Facility Name
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City
München
ZIP/Postal Code
81675
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
München
ZIP/Postal Code
D-80336
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Wuerzburg
ZIP/Postal Code
97074
Country
Germany
Individual Site Status
Recruiting
Facility Name
Research Site
City
Hadera
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Individual Site Status
Recruiting
Facility Name
Research Site
City
Petah Tikva
ZIP/Postal Code
4910000
Country
Israel
Individual Site Status
Recruiting
Facility Name
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City
Ramat Gan
ZIP/Postal Code
5266200
Country
Israel
Individual Site Status
Recruiting
Facility Name
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City
Bergamo
ZIP/Postal Code
24127
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Milano
ZIP/Postal Code
20133
Country
Italy
Individual Site Status
Recruiting
Facility Name
Research Site
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
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City
Palermo
ZIP/Postal Code
90127
Country
Italy
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Recruiting
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City
Roma
ZIP/Postal Code
00168
Country
Italy
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Recruiting
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City
Rome
ZIP/Postal Code
00189
Country
Italy
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Recruiting
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City
Treviso
ZIP/Postal Code
31100
Country
Italy
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City
Udine
ZIP/Postal Code
33100
Country
Italy
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Chiba-shi
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260-0877
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Japan
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Fukushima-shi
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960-1295
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Japan
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Higashimatsuyama
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355-0005
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Japan
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Hiroshima-shi
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734-8551
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Japan
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Isehara-shi
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259-1193
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Japan
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Itabashi-ku
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173-8610
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Japan
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Kawasaki-shi
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216-8511
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Japan
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Morioka
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020-8505
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Japan
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Nagasaki
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852-8501
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Japan
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Recruiting
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Nagoya-shi
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467-0001
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Japan
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City
Nagoya
ZIP/Postal Code
466-0065
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Japan
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Recruiting
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City
Shinjuku-ku
ZIP/Postal Code
160-0023
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Japan
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Recruiting
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City
Shinjuku-ku
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160-8582
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Japan
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Recruiting
Facility Name
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City
Shinjuku-ku
ZIP/Postal Code
162-8666
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Japan
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Recruiting
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City
Suita-shi
ZIP/Postal Code
565-0871
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Japan
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Recruiting
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City
Busan
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49241
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Korea, Republic of
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Recruiting
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Research Site
City
Daegu
ZIP/Postal Code
41404
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Korea, Republic of
Individual Site Status
Recruiting
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Research Site
City
Gwangju
ZIP/Postal Code
61469
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Korea, Republic of
Individual Site Status
Recruiting
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Research Site
City
Seoul
ZIP/Postal Code
02841
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Research Site
City
Seoul
ZIP/Postal Code
5030
Country
Korea, Republic of
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Recruiting
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City
Bydgoszcz
ZIP/Postal Code
85-086
Country
Poland
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Recruiting
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City
Katowice
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40-123
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Poland
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Recruiting
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City
Kraków
ZIP/Postal Code
31-202
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Poland
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Recruiting
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City
Kraków
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31-505
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Poland
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City
Lublin
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20064
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Poland
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Recruiting
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Poznań
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61-731
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Poland
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Almada
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2805-267
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Portugal
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Belgrade
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11000
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Serbia
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Nis
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18000
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Serbia
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Badalona(Barcelona)
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08916
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Spain
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Córdoba
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14004
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Spain
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Hospitalet de Llobregat
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08907
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Spain
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City
Madrid
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28034
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Spain
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City
Madrid
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28040
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Spain
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City
Madrid
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28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Málaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
San Sebastián de los Reyes
ZIP/Postal Code
28702
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kaohsiung City
ZIP/Postal Code
833401
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
11101
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Taipei
ZIP/Postal Code
23561
Country
Taiwan
Individual Site Status
Recruiting
Facility Name
Research Site
City
Atakum
ZIP/Postal Code
55280
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Bursa
ZIP/Postal Code
16059
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Istanbul
ZIP/Postal Code
34452
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Individual Site Status
Recruiting
Facility Name
Research Site
City
Kütahya
ZIP/Postal Code
43100
Country
Turkey
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
Learn more about this trial
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
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