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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-000460-21 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALXN1720 | Experimental | 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. |
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| Placebo | Placebo Comparator | Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALXN1720 | Combination Product | Combination product consisting of syringe prefilled with ALXN1720. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26 | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 | Baseline, Week 26 | |
| Percentage of Responders Based on Reduction of the MG-ADL Total Score at Week 26 | Response is defined as reduction of the MG-ADL total score by >= 3 points from baseline at Week 26. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Orange | California | 92868 | United States | ||
| Research Site |
Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.
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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.
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| Placebo | Combination Product | Combination product consisting of syringe prefilled with placebo. |
|
| Baseline up to Week 26 |
| Percentage of Responders based on Reduction of the QMG Total Score at Week 26 | Response is defined as reduction of the QMG total score by >= 5 points from baseline at Week 26 | Baseline up to Week 26 |
| Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 | Baseline, Week 26 |
| Change from Baseline in the QMG total score at Week 4 | Baseline, Week 4 |
| Fort Collins |
| Colorado |
| 80528 |
| United States |
| Research Site | Washington D.C. | District of Columbia | 20007 | United States |
| Research Site | Bradenton | Florida | 34209 | United States |
| Research Site | Maitland | Florida | 32751 | United States |
| Research Site | Tampa | Florida | 33612 | United States |
| Research Site | Augusta | Georgia | 30912 | United States |
| Research Site | Gainesville | Georgia | 30501 | United States |
| Research Site | Savannah | Georgia | 31406 | United States |
| Research Site | Springfield | Illinois | 62769 | United States |
| Research Site | Kansas City | Kansas | 66160 | United States |
| Research Site | Lexington | Kentucky | 40503 | United States |
| Research Site | Detroit | Michigan | 48202 | United States |
| Research Site | East Lansing | Michigan | 48824 | United States |
| Research Site | Las Vegas | Nevada | 89117 | United States |
| Research Site | Patchogue | New York | 11772 | United States |
| Research Site | Rochester | New York | 14620 | United States |
| Research Site | Syracuse | New York | 13202 | United States |
| Research Site | Chapel Hill | North Carolina | 27599 | United States |
| Research Site | North Charleston | South Carolina | 29406 | United States |
| Research Site | Houston | Texas | 77030 | United States |
| Research Site | Richmond | Virginia | 23298 | United States |
| Research Site | Morgantown | West Virginia | 26506 | United States |
| Research Site | CABA | C1192AAW | Argentina |
| Research Site | Ciudad de Buenos Aires | 1015 | Argentina |
| Research Site | Ciudad de Buenos Aires | 1181 | Argentina |
| Research Site | Ciudad de Buenos Aires | AR-CP 1221 | Argentina |
| Research Site | Rosario | S2000BZL | Argentina |
| Research Site | Innsbruck | 6020 | Austria |
| Research Site | Wels | 4600 | Austria |
| Research Site | Barretos | 14784-400 | Brazil |
| Research Site | Joinville | 89202-190 | Brazil |
| Research Site | Porto Alegre | 90620-130 | Brazil |
| Research Site | Ribeirão Preto | 14051-140 | Brazil |
| Research Site | Salvador | 41253-190 | Brazil |
| Research Site | São José do Rio Preto | 15090-000 | Brazil |
| Research Site | São Paulo | 05403-010 | Brazil |
| Research Site | Edmonton | Alberta | T6G 2G3 | Canada |
| Research Site | Toronto | Ontario | M5G 2C4 | Canada |
| Research Site | Québec | Quebec | G1J 1Z4 | Canada |
| Research Site | Beijing | 100034 | China |
| Research Site | Beijing | 100730 | China |
| Research Site | Changchun | 130021 | China |
| Research Site | Changsha | 410008 | China |
| Research Site | Chengdu | 610041 | China |
| Research Site | Fuzhou | 350001 | China |
| Research Site | Hangzhou | 310003 | China |
| Research Site | Hangzhou | 310016 | China |
| Research Site | Jinan | 250014 | China |
| Research Site | Qingdao | 266035 | China |
| Research Site | Shanghai | 200040 | China |
| Research Site | Suzhou | 215006 | China |
| Research Site | Wuhan | 430030 | China |
| Research Site | Xi'an | 710000 | China |
| Research Site | Aalborg | 9000 | Denmark |
| Research Site | Copenhagen | 2100 | Denmark |
| Research Site | Garches | 92380 | France |
| Research Site | Lille | 59037 | France |
| Research Site | Marseille | 13385 | France |
| Research Site | Nice | 06000 | France |
| Research Site | Paris | 75651 | France |
| Research Site | Strasbourg | 67098 | France |
| Research Site | Berlin | 10117 | Germany |
| Research Site | Düsseldorf | 40225 | Germany |
| Research Site | München | 81675 | Germany |
| Research Site | Würzburg | 97074 | Germany |
| Research Site | Hadera | 38100 | Israel |
| Research Site | Haifa | 3109601 | Israel |
| Research Site | Petah Tikva | 4910000 | Israel |
| Research Site | Bergamo | 24127 | Italy |
| Research Site | Brescia | 25123 | Italy |
| Research Site | Florence | 50139 | Italy |
| Research Site | Milan | 20133 | Italy |
| Research Site | Naples | 80131 | Italy |
| Research Site | Palermo | 90127 | Italy |
| Research Site | Pisa | 56126 | Italy |
| Research Site | Roma | 00168 | Italy |
| Research Site | Rome | 00189 | Italy |
| Research Site | Chiba | 260-8677 | Japan |
| Research Site | Fukushima | 960-1295 | Japan |
| Research Site | Higashimatsuyama-shi | 355-0005 | Japan |
| Research Site | Isehara-shi | 259-1193 | Japan |
| Research Site | Itabashi-ku | 173-8610 | Japan |
| Research Site | Kawasaki-shi | 216-8511 | Japan |
| Research Site | Morioka | 020-8505 | Japan |
| Research Site | Nagasaki | 852-8501 | Japan |
| Research Site | Nagoya | 466-0065 | Japan |
| Research Site | Nagoya | 467-0001 | Japan |
| Research Site | Shinjuku-ku | 160-0023 | Japan |
| Research Site | Shinjuku-ku | 160-8582 | Japan |
| Research Site | Suita-shi | 565-0871 | Japan |
| Research Site | Amsterdam | 1105 AZ | Netherlands |
| Research Site | Bydgoszcz | 85-086 | Poland |
| Research Site | Katowice | 40-689 | Poland |
| Research Site | Krakow | 31-202 | Poland |
| Research Site | Krakow | 31-505 | Poland |
| Research Site | Lublin | 20064 | Poland |
| Research Site | Poznan | 61-731 | Poland |
| Research Site | Almada | 2805-267 | Portugal |
| Research Site | Porto | 4099-001 | Portugal |
| Research Site | Belgrade | 11000 | Serbia |
| Research Site | Niš | 18000 | Serbia |
| Research Site | Busan | 49241 | South Korea |
| Research Site | Daegu | 41404 | South Korea |
| Research Site | Gwangju | 61469 | South Korea |
| Research Site | Seoul | 02841 | South Korea |
| Research Site | Seoul | 03722 | South Korea |
| Research Site | Seoul | 05505 | South Korea |
| Research Site | Seoul | 06351 | South Korea |
| Research Site | Seoul | 5030 | South Korea |
| Research Site | Badalona (Barcelona) | 08916 | Spain |
| Research Site | Córdoba | 14004 | Spain |
| Research Site | L'Hospitalet de Llobregat | 08907 | Spain |
| Research Site | Madrid | 28034 | Spain |
| Research Site | Madrid | 28040 | Spain |
| Research Site | Madrid | 28046 | Spain |
| Research Site | Madrid | 28702 | Spain |
| Research Site | Málaga | 29010 | Spain |
| Research Site | Seville | 41009 | Spain |
| Research Site | Sankt Gallen | CH-9007 | Switzerland |
| Research Site | Kaohsiung City | 833401 | Taiwan |
| Research Site | New Taipei City | 23561 | Taiwan |
| Research Site | Tainan | 70403 | Taiwan |
| Research Site | Taipei | 11101 | Taiwan |
| Research Site | Bursa | 16059 | Turkey (Türkiye) |
| Research Site | Istanbul | 34452 | Turkey (Türkiye) |
| Research Site | Kocaeli | 41380 | Turkey (Türkiye) |
| Research Site | Samsun | 55139 | Turkey (Türkiye) |
| Research Site | Liverpool | L9 7AL | United Kingdom |
| Research Site | London | EC1A 7BE | United Kingdom |
| Research Site | Oxford | 0X3 7LE | United Kingdom |
| Research Site | Sheffield | S10 2JF | United Kingdom |
| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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