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Generalized Myasthenia GravisPhase 3NIMBLENCT05070858

A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis

A Phase 3 study testing Pozelimab + Cemdisiran, Cemdisiran and Pozelimab in people with Generalized Myasthenia Gravis, run by Regeneron Pharmaceuticals at 116 sites in 19 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

This study is researching the experimental drugs called pozelimab and cemdisiran, and cemdisiran monotherapy. The study is focused on patients with generalized Myasthenia Gravis (gMG). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Generalized Myasthenia Gravis
What is being tested?
Pozelimab + Cemdisiran, Cemdisiran and Pozelimab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
288 participants
Where
116 sitesin 19 countries
Study dates
14 Dec 2021to 11 Nov 2028
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female participants ≥18 years of age at screening (or ≥ legal age of adulthood based on local regulations, whichever is older)
  • Participant with documented diagnosis of Myasthenia Gravis (MG) based on medical history and supported by previous evaluations as described in the protocol
  • 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
  • Myasthenia Gravis Foundation of America (MGFA) Clinical Classification Class II to IVa at screening
  • 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
  • Currently receiving an acetylcholinesterase inhibitor or documented reason for not using acetylcholinesterase inhibitor therapy per investigator
Show all 10Show fewer
  • Currently receiving an Immunosuppressive Therapy (IST) for MG, or documented reason why the participant is not taking an IST per investigator
  • If currently receiving an IST, not anticipated to have IST dosage changed before randomization or during Double-Blind Treatment Period (DBTP)
  • 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
  • For the optional PK sub-study: Must have a Body Mass Index (BMI) ≥ 18.5 kg/m^2 and ≤ 30 kg/m^2 at screening

Who cannot join

  • Participants 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
  • History of thymectomy within 12 months prior to screening or planned during the study
  • 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
  • Myasthenic crisis or MGFA Class V within 1 month of screening
  • 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
  • Known contraindication to meningococcal vaccines (group ACWY conjugate and group B vaccines) as described in the protocol
Show all 10Show fewer
  • 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
  • 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
  • History of Human Immunodeficiency Virus (HIV) infection or a positive test at screening per local requirements
  • NOTE: Other protocol-defined Inclusion/ Exclusion Criteria apply

Trial locations and contacts

116 sites in 19 countries.

116 sites in 19 countries

United States19 sites

  • National Neuromuscular Research Institute

    Austin, Texas, 78759

  • SFM Clinical Research, LLC

    Boca Raton, Florida, 33487

  • Dayton Center for Neurological Disorders

    Centerville, Ohio, 45459

  • University of Cincinnati Gardner Neuroscience Institute

    Cincinnati, Ohio, 45219

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado, 80907-5307

  • Wayne State University School of Medicine

    Detroit, Michigan, 48201

  • NorthShore University Health System

    Glenview, Illinois, 60026-1301

  • Nerve and Muscle Center of Texas

    Houston, Texas, 77030

  • University of California Irvine

    Irvine, California, 92697

  • University of Southern California

    Los Angeles, California, 90033

  • Diverse Clinical Research

    Miami, Florida, 33175

  • Aqualane Clinical Research

    Naples, Florida, 34105

  • St. Elizabeth's Hospital

    O'Fallon, Illinois, 62269

  • Neurological Services of Orlando

    Orlando, Florida, 32806

  • Penn Medicine University City

    Philadelphia, Pennsylvania, 19104

  • Medsol Clinical Research Center Inc

    Port Charlotte, Florida, 33952

  • Northwest Neurology Ltd. - Clinedge - PPDS

    Rolling Meadows, Illinois, 60080

  • HonorHealth Neurology 2018

    Scottsdale, Arizona, 85251

  • University of South Florida Morsani Center for Advanced Healthcare

    Tampa, Florida, 33612

Other trials in United States

China15 sites

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100032

  • The First Hospital of Jilin University

    Changchun, Jilin, 130000

  • Xiangya Hospital Central South University

    Changsha, Hunan, 410008

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Guangdong Hospital of Traditional Chinese Medicine

    Guangdong, Guangdong, 510120

  • Nanfang Hospital Southern Medical University

    Guangzhou, Guangdong, 510120

  • The First Affiliated Hospital of Guangzhou University of Chinese Medicine

    Guangzhou, Guangzhou, 510405

  • Hainan General Hospital

    Haikou, Hainan, 570311

  • Qilu Hospital of Shandong University (Qingdan)

    Qingdao, Shandong, 266035

  • Huashan Hospital Fudan University

    Shanghai, Shanghai Municipality, 201107

  • The University of Hong Kong-Shenzhen Hospital

    Shenzhen, Guangdong, 518053

  • Tianjin Medical University General Hospital

    Tianjin, Tianjin Municipality, 300050

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

    Wuhan, Hubei, 430060

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

    Xi’an, Shanxi, 710032

Other trials in China

India14 sites

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

    Bangalore, 560002

  • Postgraduate Institute of Medical Education & Research

    Chandigarh, 160012

  • Government General Hospital, Guntur

    Guntur, Andhra Pradesh, 522001

  • City Neuro Centre, Hyderabad

    Hyderabad, Telangana, 500034

  • Apex Hospital

    Jaipur, Rajasthan, 302017

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

    Kochi, Kerala, 682041

  • Polakulath Narayanan Renai Medicity Multi Specialty Hospital, Kochi

    Kochi, Punjab, 141008

  • Christian Medical College & Hospital

    Ludhiana, Punjab, 141008

  • All India Institute of Medical Sciences New Delhi

    New Delhi, National Capital Territory of Delhi, 110029

  • Nizam's Institute of Medical Sciences (NIMS)

    Panjagutta, Hyderabad, 500082

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

    Parel, Mumbai, 400012

  • Deenanath Mangeshkar Hospital and Research Centre

    Pune, Maharashtra, 411004

  • Institute of Neurosciences

    Surat, Gujarat, 395001

  • Kasturba Medical College (KMC)

    Udupi, Karnataka, 576104

Other trials in India

Japan12 sites

  • Medical Hospital of Tokyo Medical and Dental University

    Bunkyo, Tokyo, 113-8519

  • Chiba University Hospital

    Chiba, 260-8677

  • Okinawa National Hospital

    Ginowan-Shi, Okinawa, 901-2214

  • Hiroshima City Hiroshima Citiz

    Hiroshima, 730-8518

  • Saitama Medical University, Saitama Medical Center

    Kawagoe, Saitama, 350-8550

  • Kobe City Medical Center General Hospital

    Kobe, Hyōgo, 650-0047

  • Kochi Medical School Hospital

    Nankoku, Kochi, 783-8505

  • Japanese Red Cross Osaka Hospital

    Osaka, 543-8555

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

    Shimajiri, Okinawa, 901-1193

  • Tokyo Medical University Hospital

    Shinjuku, Tokyo, 160-0023

  • Nihon University Itabashi Hospital

    tabashi City, Tokyo, 173-8610

  • Yamaguchi University Hospital

    Ube, Yamaguchi, 755-8505

Other trials in Japan

Germany6 sites

  • Charite - Universitatsmedizin Berlin

    Berlin, 10117

  • University Hospital Essen

    Essen, North Rhine-Westphalia, 45127

  • Universitatsklinikum Jena

    Jena, 07747

  • Universitatsklinikum Leipzig

    Leipzig, Saxony, 04103

  • Friedrich Baur Institute

    München, Bavaria, 80336

  • Universitatsklinikum Munster

    Münster, North Rhine-Westphalia, 48149

Other trials in Germany

Poland6 sites

  • Gdanski Uniwersytet Medyczny

    Gdansk, Pomeranian Voivodeship, 80-952

  • Centrum Neurologii Klinicznej, Krakowska Akademia Neurologii

    Krakow, Lesser Poland Voivodeship, 31-505

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

    Poznan, Greater Poland Voivodeship, 61-731

  • NZOZ Neuro-kard

    Poznan, Greater Poland Voivodeship, 61-853

  • NeuroProtect

    Warsaw, Mazovian, 01-684

  • Uniwersyteckie Centrum Kliniczne WUM, Centralny Szpital Kliniczny

    Warsaw, Mosavian, 02-097

Other trials in Poland

Brazil5 sites

  • Jordy Sinapse Medicina LTDA

    Itapevi, São Paulo, 06655-250

  • IMV Pesquisa Neurologica

    Porto Alegre, Rio Grande do Sul, 90110-000

  • Faculdade de Medicina Do ABC

    Santo André, São Paulo, 09060-870

  • Pseg Centro de Pesquisa Clinica S.A

    São Paulo, 04038-002

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

    São Paulo, 05403-010

Other trials in Brazil

Georgia5 sites

  • Israeli-Georgian Medical Research Clinic Healthycore, LTD

    Tbilisi, 0112

  • LTD New Hospitals

    Tbilisi, 0114

  • Pineo Medical Ecosystem

    Tbilisi, 0114

  • LTD National Center of Urology Named after L. Managadze

    Tbilisi, 0144

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

Other trials in Georgia

Italy5 sites

  • Azienda Ospedaliera Papa Giovanni XXIII

    Bergamo, 24127

  • Fondazione IRCCS Di Rilievo Nazionale Istituto Nazionale Neurologico Carlo Besta

    Milan, Lombardy, 20133

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

  • Universita' Degli Studi di Roma La Sapienza

    Roma, 00161

  • Azienda Ospedaliera Sant'andrea

    Rome, Lazio, 00189

Other trials in Italy

Taiwan5 sites

  • Chang Gung Memorial Foundation Kaohsiung Branch

    Kaohsiung City, 833

  • China Medical University

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 701

  • Shin Kong Wu Ho Su Memorial Hospital

    Taipei, 111

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, 333

Other trials in Taiwan

Denmark4 sites

  • Aalborg Universitetshospital

    Aalborg, North Denmark, 09000

  • Aarhus University Hospital

    Aarhus N, 8200

  • Rigshospitalet, Copenhagen

    Copenhagen, 2100

  • Odense Universitetshospital

    Odense, 05000

Other trials in Denmark

France4 sites

  • CHU Bicetre

    Le Kremlin-Bicêtre, 94275

  • Centre Hospitalier Regional Universitaire (CHRU) de Nancy

    Nancy, 54035

  • Centre Hospitalier Universitaire de Nice

    Nice, Alpes Maritimes, 6002

  • Hopital de la Pitie Salpetriere

    Paris, 75013

Other trials in France

Turkey (Türkiye)4 sites

  • Dokuz Eylul University Medical Faculty

    Izmir, 35340

  • Kocaeli University Hospital

    Izmit, Van, 41380

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55239

  • Karadeniz Technical University Farabi Hospital

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Canada3 sites

  • University of Alberta

    Edmonton, Alberta, T6G 2X8

  • London Health Sciences Centre

    London, Ontario, N6A 5A5

  • Toronto General Hospital

    Toronto, Ontario, M5G2C4

Other trials in Canada

Belgium2 sites

  • Universitair Ziekenhuis Antwerpen

    Edegem, Antwerp, 2650

  • AZ Sint-Lucas

    Ghent, Oost-Vlaanderen, 9000

Other trials in Belgium

South Korea2 sites

  • Kyungpook National University Chilgok Hospital

    Daegu, 41404

  • Samsung Medical Center

    Seoul, 06351

Other trials in South Korea

Spain2 sites

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08041

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

United Kingdom2 sites

  • University Hospital Birmingham

    Birmingham, B15 2TH

  • Sheffield Teaching Hospital NHS Foundation Trust

    Sheffield, South Yorkshire, 511 9NE

Other trials in United Kingdom

Serbia1 site

  • University Clinical Centre Nis

    Niš, 700461

Other trials in Serbia

About this study

Official title: Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Monotherapy in Patients With Symptomatic Generalized Myasthenia Gravis

This study is researching the experimental drugs called pozelimab and cemdisiran, and cemdisiran monotherapy. The study is focused on patients with generalized Myasthenia Gravis (gMG). Myasthenia gravis is a disease that causes weakness and fatigue in muscles in the body because the nerves and muscles are not communicating properly.

The aim of the study is to see how effective pozelimab and cemdisiran are when used in combination and when pozelimab and cemdisiran are used alone for patients with gMG.

Read more

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drugs
  • How the study drugs work inside the body
  • How much of the study drugs are in the blood at different times
  • Whether the body makes antibodies against pozelimab and cemdisiran (which could make the drugs less effective or could lead to side effects)
Read the detailed description

DBTP- Double Blind Treatment Period (24 weeks) ETP - Extension Treatment Period (28 weeks) OLTP- Open Label Treatment Period (68 weeks) FUP-Off treatment Follow Up Period (52 weeks)

Being tested
Pozelimab + Cemdisiran, Cemdisiran, Placebo, Pozelimab
Medical subject headings
Myasthenia Gravis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pozelimab + CemdisiranDrug

    Subcutaneous administration as described in the protocol

  • CemdisiranDrug

    Also called ALN-CC5

    SC administration as described in the protocol

  • PlaceboOther

    SC administration as described in the protocol

  • PozelimabDrug

    Also called REGN3918

    SC administration as described in the protocol

Study groups in NCT05070858
Study groupRoleWhat they receive
Group 1ExperimentalPlacebo in DBTP; Re-randomized to Combination or Cemdisiran in ETP. Participants who received combination therapy during ETP and have not yet reached OLTP be reallocated to cemdisiran at the start of OLTP. In OLTP, participants on combination therapy who have not reached week 108 will switch to cemdisiran, while those who have reached week 108 will continue combination therapy
Receives: Drug: Pozelimab + Cemdisiran; Drug: Cemdisiran; Other: Placebo
Group 2ExperimentalCombination regimen in DBTP and ETP. Participants who have not yet reached OLTP will be reallocated to cemdisiran at the start of OLTP. Participants who are in OLTP and have not reached week 108 will switch to cemdisiran, while those who have reached week 108 will continue combination therapy.
Receives: Drug: Pozelimab + Cemdisiran; Drug: Cemdisiran
Group 3ExperimentalCemdisiran throughout the study
Receives: Drug: Cemdisiran
Group 4ExperimentalPozelimab monotherapy in DBTP followed by combination in ETP. Participants who have not yet reached OLTP will be reallocated to cemdisiran at the start of OLTP. Participants who are in OLTP and have not reached week 108 will switch to cemdisiran, while those who have reached week 108 will continue combination therapy.
Receives: Drug: Pozelimab + Cemdisiran; Drug: Cemdisiran; Drug: Pozelimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score

    The total MG-ADL score ranges from 0 to 24 points, with higher scores indicating greater functional impairment and disability

    Measured: From baseline to week 24

Secondary outcomes (27)

  1. Change from baseline in Quantitative Myasthenia Gravis (QMG) score

    QMG total scores range from 0 to 39, with higher scores representing greater impairment

    Measured: Week 24

  2. Achievement of a ≥3-point reduction (improvement) in MG-ADL total score

    Measured: From baseline to week 24

  3. Achievement of a ≥5-point reduction (improvement) in QMG total score

    Measured: From baseline to week 24

  4. Achievement of a consistent response on the MG-ADL

    A participant with a ≥2-point reduction (improvement) in MG-ADL total score on 2 or more consecutive assessments spanning 4 or more weeks during the DBTP

    Measured: From baseline to week 24

  5. Achievement of Minimal Symptom Expression (MSE)

    Score of 0 to 1 on the MG-ADL

    Measured: Week 24

  6. Change from baseline in the Myasthenia Gravis Composite (MGC) total score

    MGC score ranges from 0 to 50, with higher score indicating higher impairment

    Measured: Week 24

  7. Change from baseline in Myasthenia Gravis Quality of Life (MG-QOL15r) total score

    Total score ranges from 0 to 30 points; a higher score represents greater impairment

    Measured: Week 24

  8. Achievement of a ≥2-, 4-, 5-, 6-, 7-, 8-, 9-, or 10-point reduction on MG-ADL total score

    Measured: From baseline to week 24

  9. Achievement of a ≥3-, 4-, 6-, 7-, 8-, 9-, or 10-point reduction on QMG

    Measured: From baseline to week 24

  10. Incidence and severity of Treatment-Emergent Adverse Events (TEAEs) in participants treated with pozelimab + cemdisiran combination therapy, cemdisiran monotherapy or placebo

    Measured: Through week 24

  11. Incidence and severity of Serious Adverse Events (SAEs) in participants treated with pozelimab + cemdisiran combination therapy, cemdisiran monotherapy or placebo

    Measured: Through week 24

  12. Incidence and severity of Adverse Events of Special Interest (AESIs) in participants treated with pozelimab + cemdisiran combination therapy, cemdisiran monotherapy or placebo

    Measured: Through week 24

  13. Concentrations of total pozelimab in serum

    Measured: Through study duration, approximately 172 weeks

  14. Concentrations of total Complement component 5 (C5) in plasma

    Measured: Through study duration, approximately 172 weeks

  15. Concentrations of cemdisiran and its metabolites in plasma

    Measured: Through study duration, approximately 172 weeks

  16. Incidence of treatment-emergent Anti-Drug Antibodies (ADAs) to pozelimab over time

    Measured: Through study duration, approximately 172 weeks

  17. Incidence of treatment-emergent ADAs to cemdisiran over time

    Measured: Through study duration, approximately 172 weeks

  18. Change in total complement hemolysis activity assay (CH50) over time

    Measured: Through study duration, approximately 172 weeks

  19. Percent change in CH50 over time

    Measured: Through study duration, approximately 172 weeks

  20. Concentrations of cemdisiran and its metabolite in plasma

    During the OLTP for the optional PK sub-study

    Measured: At week 60 and up to week 120

  21. Concentrations of total C5 in plasma

    During the OLTP for the optional PK sub-study

    Measured: At week 60 and up to week 120

  22. Incidence of TEAEs

    During the OLTP for the optional PK sub-study

    Measured: Through week 144

  23. Severity of TEAEs

    During the OLTP for the optional PK sub-study

    Measured: Through week 144

  24. Incidence of SAEs

    During the OLTP for the optional PK sub-study

    Measured: Through week 144

  25. Severity of SAEs

    During the OLTP for the optional PK sub-study

    Measured: Through week 144

  26. Incidence of AESIs

    During the OLTP for the optional PK sub-study

    Measured: Through week 144

  27. Severity of AESIs

    During the OLTP for the optional PK sub-study

    Measured: Through week 144

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Oct 2021
  2. Study start14 Dec 2021
  3. Primary completion8 Jul 2025
  4. Study completion11 Nov 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
288 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05070858
Sponsor's protocol ID
R3918-MG-2018
Other IDs
2020-003272-41, 2023-508842-17-00, 2023
Acronym
NIMBLE
Status last verified
Oct 2026
First submitted
27 Sep 2021
Last updated
28 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Publications

  • Vu T, Habib AA, Jacob S, Mantegazza R, Murai H, Vissing J, Shaibani A, Levine T, Hussain Y, Meisel A, Adamczak-Ratajczak A, Ilkowski J, Sgobbi P, Guerreiro A, Luo S, Pavani R, Chaudhari U, Jalali N, DeVeaux M, Moore W, Meagher KA, Burczynski ME, Kokate S, Sherman S, Pawaskar D, Singh N, Souttou A, Sirulnik A, Perlee L, Yancopoulos GD, Howard JF Jr; NIMBLE Trial Investigators. Efficacy and safety of cemdisiran siRNA in myasthenia gravis (NIMBLE): a double-blind, randomised, placebo-controlled, phase 3 trial. Lancet. 2026 May 2;407(10540):1712-1725. doi: 10.1016/S0140-6736(26)00690-2. Epub 2026 Apr 21.

    PubMed 42030965

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pozelimab + Cemdisiran, Cemdisiran and Pozelimab in people with Generalized Myasthenia Gravis, run by Regeneron Pharmaceuticals at 116 sites in 19 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 116 sites in United States, China, India, Japan, Germany and 14 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Myasthenia Gravis-Activities of Daily Living (MG-ADL) total score (time frame: From baseline to week 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05070858, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.

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