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New drug duo aims to ease muscle weakness in myasthenia gravis

NCT ID NCT05070858

Disease control Sponsor: Regeneron Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times

Summary

This study tests two experimental drugs, pozelimab and cemdisiran, alone or together, in 288 adults with generalized myasthenia gravis (gMG), a disease that causes muscle weakness and fatigue. The goal is to see if the drugs improve daily activities and muscle strength. Participants must have a confirmed diagnosis and specific antibodies. The study is active but not recruiting.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

288 people

The number who actually took part.

Started

Dec 2021

Expected to finish

Nov 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria: 1. Male or female participants ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older) 2. Participant with documented diagnosis of Myasthenia Gravis (MG) based on medical history and supported by previous evaluations as described in the protocol 3. Documented prior history of positive serologic test or a positive result during screening of Anti-acetylcholine Receptor (AChR) antibodies or anti-Lipoprotein Receptor-related Protein 4 (LRP4) antibodies. 4. Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening 5. Myasthenia Gravis-Activities of Daily Living (MG-ADL) score ≥6 at screening. Ocular items should not contribute more than 50% of MG-ADL total score as described in the protocol 6. Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator 7. Currently receiving an Immunosuppressive Therapy (IST) for MG, or documented reason why the participant is not taking an IST per investigator 8. If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during Double-Blind Treatment Period (DBTP). 9. Willing and able to comply with clinic visits and study-related procedures, including completion of the primary series of the meningococcal vaccinations required per protocol Key Exclusion Criteria: 1. Patients with antibody profile that is only positive for Muscle-Specific tyrosine Kinase (MuSK) (MuSK positivity is based on a documented prior history of positive serologic test for antibodies to MuSK or a positive result during screening 2. History of thymectomy within 12 months prior to screening or planned during the study 3. History of malignant thymoma (patients with stage 1 may be enrolled), or history of cancer within the past 5 years, except for adequately treated basal cell skin cancer, squamous cell skin cancer, or in situ cervical cancer 4. Myasthenic crisis or MGFA Class V within 1 month of screening 5. Not meeting meningococcal vaccination requirements and, at a minimum, documentation of quadrivalent meningococcal vaccination within 5 years prior to randomization and serotype B vaccine (when available) within 3 years prior to randomization as described in the protocol 6. Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol 7. Participants who require antibiotics for meningococcal prophylaxis and have a contraindication, warning, or precaution precluding the use of penicillin class and penicillin-alternative antibiotics planned to be used for prophylaxis, or a history of intolerance leading to the discontinuation of these antibiotics 8. Positive hepatitis B surface antigen or hepatitis C virus Ribonucleic Acid (RNA) during screening. NOTE: Cases with unclear interpretation should be discussed with the medical monitor 9. History of Human Immunodeficiency Virus (HIV) infection or a positive test at screening per local requirements NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Generalized myasthenia gravis

Contacts and locations

Locations

  • AZ Sint-Lucas

    Ghent, Oost-Vlaanderen, 9000, Belgium

  • Aalborg Universitetshospital

    Aalborg, North Denmark, 09000, Denmark

  • Aarhus University Hospital

    Aarhus N, 8200, Denmark

  • All India Institute of Medical Sciences New Delhi

    New Delhi, National Capital Territory of Delhi, 110029, India

  • Amrita Institute of Medical Sciences and Research Centre (AIMS)

    Kochi, Kerala, 682041, India

  • Apex Hospital

    Jaipur, Rajasthan, 302017, India

  • Aqualane Clinical Research

    Naples, Florida, 34105, United States

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127, Italy

  • Azienda Ospedaliera Sant'andrea

    Rome, Lazio, 00189, Italy

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126, Italy

  • Bangalore Medical College and Research Institute (BMCRI) - Victoria Hospital

    Bangalore, 560002, India

  • CHU Bicetre

    Le Kremlin-Bicêtre, 94275, France

  • Centre Hospitalier Regional Universitaire (CHRU) de Nancy

    Nancy, 54035, France

  • Centre Hospitalier Universitaire de Nice

    Nice, Alpes Maritimes, 6002, France

  • Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

    Krakow, Lesser Poland Voivodeship, 31-505, Poland

  • Chang Gung Memorial Foundation Kaohsiung Branch

    Kaohsiung City, 833, Taiwan

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 333, Taiwan

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117, Germany

  • Chiba University Hospital

    Chiba, 260-8677, Japan

  • China Medical University

    Taichung, 40447, Taiwan

  • Christian Medical College & Hospital

    Ludhiana, Punjab, 141008, India

  • City Neuro Centre, Hyderabad

    Hyderabad, Telangana, 500034, India

  • Clinical Research Center Spolka z Ograniczona Odpowiedzialnoscia Medic-R Sp.k

    Poznan, Greater Poland Voivodeship, 61-731, Poland

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907-5307, United States

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459, United States

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra, 411004, India

  • Diverse Clinical Research

    Miami, Florida, 33175, United States

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340, Turkey (Türkiye)

  • Faculdade de Medicina Do ABC

    Santo André, São Paulo, 09060-870, Brazil

  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

    Milan, Lombardy, 20133, Italy

  • Friedrich Baur Institute

    München, Bavaria, 80336, Germany

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001, China

  • Gdanski Uniwersytet Medyczny

    Gdansk, Pomeranian Voivodeship, 80-952, Poland

  • Government General Hospital, Guntur

    Guntur, Andhra Pradesh, 522001, India

  • Guangdong Hospital of Traditional Chinese Medicine

    Guangdong, Guangdong, 510120, China

  • Hainan General Hospital

    Haikou, Hainan, 570311, China

  • Hiroshima City Hiroshima Citiz

    Hiroshima, 730-8518, Japan

  • HonorHealth Neurology 2018

    Scottsdale, Arizona, 85251, United States

  • Hopital de la Pitie Salpetriere

    Paris, 75013, France

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

    São Paulo, 05403-010, Brazil

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041, Spain

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 201107, China

  • IMV Pesquisa Neurologica

    Porto Alegre, Rio Grande do Sul, 90110-000, Brazil

  • Institute of Neurosciences

    Surat, Gujarat, 395001, India

  • Israeli-Georgian Medical Research Clinic Healthycore, LTD

    Tbilisi, 0112, Georgia

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555, Japan

  • Jordy Sinapse Medicina LTDA

    Itapevi, São Paulo, 06655-250, Brazil

  • Karadeniz Technical University Farabi Hospital

    Trabzon, 61080, Turkey (Türkiye)

  • Kasturba Medical College (KMC)

    Udupi, Karnataka, 576104, India

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047, Japan

  • Kocaeli University Hospital

    Izmit, Van, 41380, Turkey (Türkiye)

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505, Japan

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404, South Korea

  • LTD National Center of Urology Named after L. Managadze

    Tbilisi, 0144, Georgia

  • LTD New Hospitals

    Tbilisi, 0114, Georgia

  • London Health Sciences Centre

    London, Ontario, N6A 5A5, Canada

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo, Tokyo, 113-8519, Japan

  • Medsol Clinical Research Center Inc

    Port Charlotte, Florida, 33952, United States

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186, Georgia

  • NZOZ Neuro-kard

    Poznan, Greater Poland Voivodeship, 61-853, Poland

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510120, China

  • National Cheng Kung University Hospital

    Tainan, 701, Taiwan

  • National Neuromuscular Research Institute

    Austin, Texas, 78759, United States

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030, United States

  • NeuroProtect

    Warsaw, Mazovian, 01-684, Poland

  • Neurological Services of Orlando

    Orlando, Florida, 32806, United States

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610, Japan

  • Nizam's Institute of Medical Sciences (NIMS)

    Panjagutta, Hyderabad, 500082, India

  • NorthShore University Health System

    Glenview, Illinois, 60026-1301, United States

  • Northwest Neurology Ltd. - Clinedge - PPDS

    Rolling Meadows, Illinois, 60080, United States

  • Odense Universitetshospital

    Odense, 05000, Denmark

  • Okinawa National Hospital

    Ginowan-Shi, Okinawa, 901-2214, Japan

  • Okinawa Prefectural Nanbu Medical Center and Children's Medical Center

    Shimajiri, Okinawa, 901-1193, Japan

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55239, Turkey (Türkiye)

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032, China

  • Penn Medicine University City

    Philadelphia, Pennsylvania, 19104, United States

  • Pineo Medical Ecosystem

    Tbilisi, 0114, Georgia

  • Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi

    Kochi, Punjab, 141008, India

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012, India

  • Pseg Centro de Pesquisa Clinica S.A

    São Paulo, 04038-002, Brazil

  • Qilu Hospital of Shandong University (Qingdan)

    Qingdao, Shandong, 266035, China

  • Renmin Hospital of Wuhan University - Hubei Provincial People's Hospital

    Wuhan, Hubei, 430060, China

  • Rigshospitalet, Copenhagen

    Copenhagen, 2100, Denmark

  • SFM Clinical Research, LLC

    Boca Raton, Florida, 33487, United States

  • Saitama Medical University, Saitama Medical Center

    Kawagoe, Saitama, 350-8550, Japan

  • Samsung Medical Center

    Seoul, 06351, South Korea

  • Seth G.S. Medical College & K.E.M. Hospital, Mumbai

    Pārel, Mumbai, 400012, India

  • Sheffield Teaching Hospital NHS Foundation Trust

    Sheffield, South Yorkshire, 511 9NE, United Kingdom

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei, 111, Taiwan

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • St. Elizabeth's Hospital

    O'Fallon, Illinois, 62269, United States

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangzhou, 510405, China

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000, China

  • The Second Affiliated Hospital of the Chinese Peoples' Liberation Army Air Force Medical University

    Xi’an, Shanxi, 710032, China

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053, China

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300050, China

  • Tokyo Medical University Hospital

    Shinjuku, Tokyo, 160-0023, Japan

  • Toronto General Hospital

    Toronto, Ontario, M5G2C4, Canada

  • Universita' Degli Studi di Roma La Sapienza

    Roma, 00161, Italy

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp, 2650, Belgium

  • Universitatsklinikum Jena

    Jena, 07747, Germany

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103, Germany

  • Universitatsklinikum Munster

    Münster, North Rhine-Westphalia, 48149, Germany

  • University Clinical Centre Nis

    Niš, 700461, Serbia

  • University Hospital Birmingham

    Birmingham, B15 2TH, United Kingdom

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45127, Germany

  • University of Alberta

    Edmonton, Alberta, T6G 2X8, Canada

  • University of California Irvine

    Irvine, California, 92697, United States

  • University of Cincinnati Gardner Neuroscience Institute

    Cincinnati, Ohio, 45219, United States

  • University of South Florida Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612, United States

  • University of Southern California

    Los Angeles, California, 90033, United States

  • Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny

    Warsaw, Mosavian, 02-097, Poland

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201, United States

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008, China

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505, Japan

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