Generalized Myasthenia Gravis Clinical Trial
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
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).
| Status | Recruiting |
| Enrollment | 254 |
| Est. completion date | July 7, 2027 |
| Est. primary completion date | August 5, 2025 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Buenos Aires | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Caba | |
| Argentina | Research Site | Capital Federal | |
| Argentina | Research Site | Rosario | |
| Austria | Research Site | Innsbruck | |
| Austria | Research Site | Vienna | |
| Austria | Research Site | Wels-Grieskirchen | |
| Brazil | Research Site | Barretos | |
| Brazil | Research Site | Joinville | |
| Brazil | Research Site | Porto Alegre | |
| Brazil | Research Site | Ribeirão Preto | |
| Brazil | Research Site | Salvador | |
| Brazil | Research Site | Sao Jose Do Rio Preto | |
| Brazil | Research Site | Sao Paulo | |
| Brazil | Research Site | São Paulo | |
| Canada | Research Site | Edmonton | Alberta |
| Canada | Research Site | London | Ontario |
| Canada | Research Site | Montreal | Quebec |
| Canada | Research Site | Quebec City | Quebec |
| Canada | Research Site | Toronto | Ontario |
| China | Research Site | Beijing | |
| China | Research Site | Beijing | |
| China | Research Site | Changchun | |
| China | Research Site | Changsha | |
| China | Research Site | Chengdu | |
| China | Research Site | Chongqing | |
| China | Research Site | Fuzhou | |
| China | Research Site | Hangzhou | |
| China | Research Site | Hangzhou | |
| China | Research Site | Jinan | |
| China | Research Site | Qingdao | |
| China | Research Site | Shanghai | |
| China | Research Site | Suzhou | |
| China | Research Site | Wuhan | |
| China | Research Site | Xi'an | |
| Denmark | Research Site | Aalborg | |
| Denmark | Research Site | København Ø | |
| France | Research Site | Angers | |
| France | Research Site | Garches | |
| France | Research Site | Lille | |
| France | Research Site | Marseille | |
| France | Research Site | Montpellier Cedex 5 | |
| France | Research Site | Nice | |
| France | Research Site | Paris Cedex 13 | |
| France | Research Site | Strasbourg Cedex | |
| Germany | Research Site | Berlin | |
| Germany | Research Site | Düsseldorf | |
| Germany | Research Site | Giessen | |
| Germany | Research Site | München | |
| Germany | Research Site | München | |
| Germany | Research Site | Tübingen | |
| Germany | Research Site | Wuerzburg | |
| Israel | Research Site | Hadera | |
| Israel | Research Site | Haifa | |
| Israel | Research Site | Petah Tikva | |
| Israel | Research Site | Ramat Gan | |
| Italy | Research Site | Bergamo | |
| Italy | Research Site | Brescia | |
| Italy | Research Site | Firenze | |
| Italy | Research Site | Milano | |
| Italy | Research Site | Napoli | |
| Italy | Research Site | Palermo | |
| Italy | Research Site | Roma | |
| Italy | Research Site | Rome | |
| Italy | Research Site | Treviso | |
| Italy | Research Site | Udine | |
| Japan | Research Site | Chiba-shi | |
| Japan | Research Site | Fukushima-shi | |
| Japan | Research Site | Higashimatsuyama | |
| Japan | Research Site | Hiroshima-shi | |
| Japan | Research Site | Isehara-shi | |
| Japan | Research Site | Itabashi-ku | |
| Japan | Research Site | Kawasaki-shi | |
| Japan | Research Site | Morioka | |
| Japan | Research Site | Nagasaki | |
| Japan | Research Site | Nagoya | |
| Japan | Research Site | Nagoya-shi | |
| Japan | Research Site | Ota-ku | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Shinjuku-ku | |
| Japan | Research Site | Suita-shi | |
| Korea, Republic of | Research Site | Busan | |
| Korea, Republic of | Research Site | Daegu | |
| Korea, Republic of | Research Site | Gwangju | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Korea, Republic of | Research Site | Seoul | |
| Netherlands | Research Site | Amsterdam | |
| Poland | Research Site | Bydgoszcz | |
| Poland | Research Site | Katowice | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Kraków | |
| Poland | Research Site | Lublin | |
| Poland | Research Site | Poznan | |
| Portugal | Research Site | Almada | |
| Portugal | Research Site | Porto | |
| Serbia | Research Site | Belgrade | |
| Serbia | Research Site | Nis | |
| Spain | Research Site | Badalona(Barcelona) | |
| Spain | Research Site | Córdoba | |
| Spain | Research Site | Hospitalet de Llobregat | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Madrid | |
| Spain | Research Site | Málaga | |
| Spain | Research Site | Pamplona | |
| Spain | Research Site | San Sebastián de los Reyes | |
| Spain | Research Site | Sevilla | |
| Switzerland | Research Site | Lugano | |
| Switzerland | Research Site | St. Gallen | |
| Switzerland | Research Site | Zürich | |
| Taiwan | Research Site | Kaohsiung City | |
| Taiwan | Research Site | Tainan City | |
| Taiwan | Research Site | Taipei | |
| Taiwan | Research Site | Taipei | |
| Turkey | Research Site | Atakum | |
| Turkey | Research Site | Bursa | |
| Turkey | Research Site | Istanbul | |
| Turkey | Research Site | Kocaeli | |
| Turkey | Research Site | Kütahya | |
| United Kingdom | Research Site | Liverpool | |
| United Kingdom | Research Site | London | |
| United Kingdom | Research Site | Oxford | |
| United Kingdom | Research Site | Sheffield | |
| United States | Research Site | Augusta | Georgia |
| United States | Research Site | Aurora | Colorado |
| United States | Research Site | Boston | Massachusetts |
| United States | Research Site | Bradenton | Florida |
| United States | Research Site | Brighton | Massachusetts |
| United States | Research Site | Chapel Hill | North Carolina |
| United States | Research Site | Detroit | Michigan |
| United States | Research Site | Durham | North Carolina |
| United States | Research Site | East Lansing | Michigan |
| United States | Research Site | Fort Collins | Colorado |
| United States | Research Site | Gainesville | Georgia |
| United States | Research Site | Kansas City | Kansas |
| United States | Research Site | Las Vegas | Nevada |
| United States | Research Site | Lexington | Kentucky |
| United States | Research Site | Los Angeles | California |
| United States | Research Site | Madison | Wisconsin |
| United States | Research Site | Maitland | Florida |
| United States | Research Site | McAllen | Texas |
| United States | Research Site | Morgantown | West Virginia |
| United States | Research Site | North Charleston | South Carolina |
| United States | Research Site | Orange | California |
| United States | Research Site | Orlando | Florida |
| United States | Research Site | Patchogue | New York |
| United States | Research Site | Phoenix | Arizona |
| United States | Research Site | Portland | Oregon |
| United States | Research Site | Rancho Mirage | California |
| United States | Research Site | Richmond | Virginia |
| United States | Research Site | Rochester | New York |
| United States | Research Site | Savannah | Georgia |
| United States | Research Site | Seattle | Washington |
| United States | Research Site | Springfield | Illinois |
| United States | Research Site | Syracuse | New York |
| United States | Research Site | Tampa | Florida |
| United States | Research Site | Washington | District of Columbia |
| Lead Sponsor | Collaborator |
|---|---|
| Alexion Pharmaceuticals, Inc. |
United States, Argentina, Austria, Brazil, Canada, China, Denmark, France, Germany, Israel, Italy, Japan, Korea, Republic of, Netherlands, Poland, Portugal, Serbia, Spain, Switzerland, Taiwan, Turkey, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score at Week 26 | Baseline, Week 26 | ||
| Secondary | Change From Baseline in Quantitative Myasthenia Gravis (QMG) Total Score at Week 26 | Baseline, Week 26 | ||
| Secondary | 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. | Baseline up to Week 26 | |
| Secondary | 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 | |
| Secondary | Change From Baseline in Myasthenia Gravis Composite (MGC) Total Score at Week 26 | Baseline, Week 26 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Active, not recruiting |
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