Trial Title:
Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis
NCT ID:
NCT05556096
Condition:
Generalized Myasthenia Gravis
Conditions: Official terms:
Myasthenia Gravis
Muscle Weakness
Conditions: Keywords:
ALXN1720
anti-acetylcholine receptor antibody-positive
acetylcholine receptor
AChR
generalized myasthenia gravis
myasthenia gravis
MG
gMG
complement component 5
C5
VHH antibody
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention 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.
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Combination Product
Intervention name:
ALXN1720
Description:
Combination product consisting of syringe prefilled with ALXN1720.
Arm group label:
ALXN1720
Intervention type:
Combination Product
Intervention name:
Placebo
Description:
Combination product consisting of syringe prefilled with placebo.
Arm group label:
Placebo
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).
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Research Site
Address:
City:
Scottsdale
Zip:
85251
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orange
Zip:
92868
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rancho Mirage
Zip:
92270
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sylmar
Zip:
91342
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Aurora
Zip:
80045
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fort Collins
Zip:
80528
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Washington
Zip:
20007
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bradenton
Zip:
34209
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Maitland
Zip:
32751
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Orlando
Zip:
32804
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Tampa
Zip:
33612
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Augusta
Zip:
30912
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gainesville
Zip:
30501
Country:
United States
Status:
Completed
Facility:
Name:
Research Site
Address:
City:
Savannah
Zip:
31406
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Springfield
Zip:
62769
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kansas City
Zip:
66160
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lexington
Zip:
40503
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Boston
Zip:
02115
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brighton
Zip:
02135
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Detroit
Zip:
48202
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
East Lansing
Zip:
48824
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Las Vegas
Zip:
89117
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Patchogue
Zip:
11772
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rochester
Zip:
14620
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Syracuse
Zip:
13202
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Portland
Zip:
97239
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
North Charleston
Zip:
29406
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Houston
Zip:
77098
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
McAllen
Zip:
78503
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Richmond
Zip:
23298
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seattle
Zip:
98122
Country:
United States
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Morgantown
Zip:
26506
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madison
Zip:
53705
Country:
United States
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Buenos Aires
Zip:
1015
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Buenos Aires
Zip:
AR-CP 1221
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Caba
Zip:
1181
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Caba
Zip:
C1192AAW
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Capital Federal
Zip:
C1428AQK
Country:
Argentina
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Rosario
Zip:
S2000BZL
Country:
Argentina
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Innsbruck
Zip:
6020
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Vienna
Zip:
1090
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Wels-Grieskirchen
Zip:
4600
Country:
Austria
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Barretos
Zip:
14784-400
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Joinville
Zip:
89202-190
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Porto Alegre
Zip:
90110-000
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Ribeirão Preto
Zip:
14051-140
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Salvador
Zip:
41253-190
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Jose Do Rio Preto
Zip:
15090-000
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Sao Paulo
Zip:
05403-000
Country:
Brazil
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
São Paulo
Zip:
0438-002
Country:
Brazil
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Edmonton
Zip:
T6G 2G3
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
N6A 5A5
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Toronto
Zip:
M5G 2C4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montreal
Zip:
H4A 3TA
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Quebec City
Zip:
G1J 1Z4
Country:
Canada
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100034
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Beijing
Zip:
100730
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Changchun
Zip:
130021
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Changsha
Zip:
410008
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Chengdu
Zip:
610041
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Chongqing
Zip:
400016
Country:
China
Status:
Suspended
Facility:
Name:
Research Site
Address:
City:
Fuzhou
Zip:
350001
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310003
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Hangzhou
Zip:
310020
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Jinan
Zip:
250014
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Qingdao
Zip:
266035
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Shanghai
Zip:
201107
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Suzhou
Zip:
215006
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Wuhan
Zip:
430030
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Xi'an
Zip:
710000
Country:
China
Status:
Active, not recruiting
Facility:
Name:
Research Site
Address:
City:
Aalborg
Zip:
9000
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
København Ø
Zip:
2100
Country:
Denmark
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Angers
Zip:
49033
Country:
France
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Garches
Zip:
92380
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Marseille
Zip:
13385
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Montpellier
Zip:
34295
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nice
Zip:
06000
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Paris
Zip:
75651
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Strasbourg
Zip:
67098
Country:
France
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Berlin
Zip:
10117
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Düsseldorf
Zip:
40225
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Giessen
Zip:
35392
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
München
Zip:
81675
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
München
Zip:
D-80336
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tübingen
Zip:
72076
Country:
Germany
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Wuerzburg
Zip:
97074
Country:
Germany
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hadera
Country:
Israel
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Haifa
Zip:
3109601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Petah Tikva
Zip:
4910000
Country:
Israel
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ramat Gan
Zip:
5266200
Country:
Israel
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bergamo
Zip:
24127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Brescia
Zip:
25123
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Firenze
Zip:
50139
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Milano
Zip:
20133
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Napoli
Zip:
80131
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Palermo
Zip:
90127
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pisa
Zip:
56126
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Roma
Zip:
00168
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Rome
Zip:
00189
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Salerno
Zip:
84131
Country:
Italy
Status:
Withdrawn
Facility:
Name:
Research Site
Address:
City:
Treviso
Zip:
31100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Udine
Zip:
33100
Country:
Italy
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Chiba-shi
Zip:
260-0877
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Fukushima-shi
Zip:
960-1295
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Higashimatsuyama
Zip:
355-0005
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hiroshima-shi
Zip:
734-8551
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Isehara-shi
Zip:
259-1193
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Itabashi-ku
Zip:
173-8610
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kawasaki-shi
Zip:
216-8511
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Morioka
Zip:
020-8505
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagasaki
Zip:
852-8501
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya-shi
Zip:
467-0001
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nagoya
Zip:
466-0065
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Ota-ku
Zip:
143-8541
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinjuku-ku
Zip:
160-0023
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinjuku-ku
Zip:
160-8582
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Shinjuku-ku
Zip:
162-8666
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Suita-shi
Zip:
565-0871
Country:
Japan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Busan
Zip:
49241
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Daegu
Zip:
41404
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Gwangju
Zip:
61469
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
02841
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
03722
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
05505
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
06351
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Seoul
Zip:
5030
Country:
Korea, Republic of
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Amsterdam
Zip:
1105 AZ
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bydgoszcz
Zip:
85-086
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Katowice
Zip:
40-689
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-202
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kraków
Zip:
31-505
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lublin
Zip:
20064
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Poznań
Zip:
61-731
Country:
Poland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Almada
Zip:
2805-267
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Porto
Zip:
4099-001
Country:
Portugal
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Belgrade
Zip:
11000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Nis
Zip:
18000
Country:
Serbia
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Badalona(Barcelona)
Zip:
08916
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Córdoba
Zip:
14004
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Hospitalet de Llobregat
Zip:
08907
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28040
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28046
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Madrid
Zip:
28702
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Málaga
Zip:
29010
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Pamplona
Zip:
31008
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sevilla
Zip:
41009
Country:
Spain
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Lugano
Zip:
CH-6900
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
St. Gallen
Zip:
CH-9007
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Zürich
Zip:
8091
Country:
Switzerland
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kaohsiung City
Zip:
833401
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Tainan City
Zip:
70403
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
11101
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Taipei
Zip:
23561
Country:
Taiwan
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Atakum
Zip:
55280
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Bursa
Zip:
16059
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Istanbul
Zip:
34452
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kocaeli
Zip:
41380
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Kütahya
Zip:
43100
Country:
Turkey
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Liverpool
Zip:
L9 7AL
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
London
Zip:
EC1A 7BE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Oxford
Zip:
0X3 7LE
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
Research Site
Address:
City:
Sheffield
Zip:
S10 2JF
Country:
United Kingdom
Status:
Recruiting
Start date:
November 21, 2022
Completion date:
July 7, 2027
Lead sponsor:
Agency:
Alexion Pharmaceuticals, Inc.
Agency class:
Industry
Source:
Alexion Pharmaceuticals, Inc.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05556096
