Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis

NCT ID: NCT05556096

Last Updated: 2026-01-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

261 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-21

Study Completion Date

2027-08-31

Brief Summary

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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).

Detailed Description

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Conditions

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Generalized Myasthenia Gravis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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ALXN1720

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.

Group Type EXPERIMENTAL

ALXN1720

Intervention Type COMBINATION_PRODUCT

Combination product consisting of syringe prefilled with ALXN1720.

Placebo

Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Combination product consisting of syringe prefilled with placebo.

Interventions

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ALXN1720

Combination product consisting of syringe prefilled with ALXN1720.

Intervention Type COMBINATION_PRODUCT

Placebo

Combination product consisting of syringe prefilled with placebo.

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Alexion Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Research Site

Beijing, , China

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Beijing, , China

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Changchun, , China

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Changsha, , China

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Chengdu, , China

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Fuzhou, , China

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Hangzhou, , China

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Hangzhou, , China

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Jinan, , China

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Qingdao, , China

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Shanghai, , China

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Suzhou, , China

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Wuhan, , China

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Xi'an, , China

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Aalborg, , Denmark

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Copenhagen, , Denmark

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Garches, , France

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Lille, , France

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Marseille, , France

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Nice, , France

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Paris, , France

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Strasbourg, , France

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Berlin, , Germany

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Düsseldorf, , Germany

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München, , Germany

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Würzburg, , Germany

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Hadera, , Israel

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Haifa, , Israel

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Petah Tikva, , Israel

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Bergamo, , Italy

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Brescia, , Italy

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Florence, , Italy

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Milan, , Italy

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Napoli, , Italy

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Palermo, , Italy

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Pisa, , Italy

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Roma, , Italy

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Rome, , Italy

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Chiba, , Japan

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Fukushima, , Japan

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Higashimatsuyama-shi, , Japan

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Isehara-shi, , Japan

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Itabashi-ku, , Japan

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Kawasaki-shi, , Japan

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Morioka, , Japan

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Nagasaki, , Japan

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Nagoya, , Japan

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Nagoya, , Japan

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Shinjuku-ku, , Japan

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Shinjuku-ku, , Japan

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Suita-shi, , Japan

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Amsterdam, , Netherlands

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Bydgoszcz, , Poland

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Katowice, , Poland

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Krakow, , Poland

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Krakow, , Poland

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Lublin, , Poland

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Poznan, , Poland

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Almada, , Portugal

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Porto, , Portugal

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Belgrade, , Serbia

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Niš, , Serbia

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Busan, , South Korea

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Daegu, , South Korea

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Gwangju, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Badalona (Barcelona), , Spain

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Córdoba, , Spain

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L'Hospitalet de Llobregat, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Málaga, , Spain

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Seville, , Spain

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Sankt Gallen, , Switzerland

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Kaohsiung City, , Taiwan

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New Taipei City, , Taiwan

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Tainan, , Taiwan

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Taipei, , Taiwan

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Bursa, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Kocaeli, , Turkey (Türkiye)

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Samsun, , Turkey (Türkiye)

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Liverpool, , United Kingdom

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London, , United Kingdom

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Oxford, , United Kingdom

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Sheffield, , United Kingdom

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Orange, California, United States

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Fort Collins, Colorado, United States

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Washington D.C., District of Columbia, United States

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Bradenton, Florida, United States

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Maitland, Florida, United States

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Tampa, Florida, United States

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Augusta, Georgia, United States

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Gainesville, Georgia, United States

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Savannah, Georgia, United States

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Springfield, Illinois, United States

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Kansas City, Kansas, United States

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Lexington, Kentucky, United States

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Detroit, Michigan, United States

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East Lansing, Michigan, United States

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Las Vegas, Nevada, United States

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Patchogue, New York, United States

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Rochester, New York, United States

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Syracuse, New York, United States

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Chapel Hill, North Carolina, United States

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North Charleston, South Carolina, United States

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Houston, Texas, United States

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Richmond, Virginia, United States

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Morgantown, West Virginia, United States

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CABA, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Ciudad de Buenos Aires, , Argentina

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Rosario, , Argentina

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Innsbruck, , Austria

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Wels, , Austria

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Barretos, , Brazil

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Joinville, , Brazil

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Porto Alegre, , Brazil

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Ribeirão Preto, , Brazil

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Salvador, , Brazil

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São José do Rio Preto, , Brazil

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São Paulo, , Brazil

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Edmonton, Alberta, Canada

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Toronto, Ontario, Canada

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Québec, Quebec, Canada

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Countries

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United States Argentina Austria Brazil Canada China Denmark France Germany Israel Italy Japan Netherlands Poland Portugal Serbia South Korea Spain Switzerland Taiwan Turkey (Türkiye) United Kingdom

Other Identifiers

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2022-000460-21

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

ALXN1720-MG-301

Identifier Type: -

Identifier Source: org_study_id

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