Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

New drug batoclimab aims to ease muscle weakness in myasthenia gravis

NCT ID NCT05403541

Disease control Sponsor: Immunovant Sciences GmbH 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Sep 15, 2026 · Updated 3 times

Summary

This phase 3 trial tests batoclimab, a drug that blocks certain antibodies, in 240 adults with generalized myasthenia gravis (gMG). The study measures if batoclimab improves daily activities and muscle strength compared to a placebo. Participants receive injections weekly or bi-weekly over several periods, with long-term follow-up for those who respond.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
batoclimab (a drug that blocks certain antibodies to reduce muscle weakness)
What this could lead to
If successful, batoclimab could offer a new treatment option to control symptoms and improve daily function for people with generalized myasthenia gravis.
What could go wrong
This is a phase 3 trial, but results are not yet available. The drug may not work better than placebo, and side effects are possible. It is not a cure, and ongoing treatment may be needed.

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

233 people

The number who actually took part.

Started

Jun 2022

Finished

Aug 2026

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.

Inclusion Criteria: 1. Are ≥ 18 years of age at the Screening Visit. 2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit. 3. Have a QMG score ≥ 11 at the Screening and Baseline Visits. 4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits. 5. Additional inclusion criteria are defined in the protocol. Exclusion Criteria: 1. Have experienced myasthenic crisis within 3 months of the Screening Visit. 2. Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study period. 3. Have any active or untreated malignant thymoma. 4. Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies) within the past year. 5. Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment. 6. Additional exclusion criteria are defined in the protocol.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Generalized myasthenia gravis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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

  • Site Number - 1008

    Durham, North Carolina, 27710, United States

  • Site Number - 1012

    Olive View, California, 91342, United States

  • Site Number - 1014

    Round Rock, Texas, 78681, United States

  • Site Number - 1015

    Tampa, Florida, 33612, United States

  • Site Number - 1018

    Chapel Hill, North Carolina, 27599, United States

  • Site Number - 1019

    Orlando, Florida, 32806, United States

  • Site Number - 1020

    Miami, Florida, 33136, United States

  • Site Number - 1021

    Buffalo, New York, 14203, United States

  • Site Number - 1023

    Philadelphia, Pennsylvania, 19104, United States

  • Site Number - 1024

    Minneapolis, Minnesota, 55414, United States

  • Site Number - 1025

    New Haven, Connecticut, 06519, United States

  • Site Number - 1026

    Memphis, Tennessee, 38120, United States

  • Site Number - 1027

    Aurora, Colorado, 80045, United States

  • Site Number - 1028

    Port Charlotte, Florida, 33952, United States

  • Site Number - 1034

    Houston, Texas, 77030, United States

  • Site Number - 2002

    Toronto, Ontario, M5G 2C4, Canada

  • Site Number - 2003

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Site Number - 2004

    Montreal, Quebec, H3A 2B4, Canada

  • Site Number - 2601

    Mexico City, 06700, Mexico

  • Site Number - 3003

    Krakow, 31-503, Poland

  • Site Number - 3005

    Warsaw, 01-684, Poland

  • Site Number - 3007

    Gdansk, 80-214, Poland

  • Site Number - 3008

    Lublin, 20-701, Poland

  • Site Number - 3503

    Madrid, 28046, Spain

  • Site Number - 4001

    Osaka, 589-8511, Japan

  • Site Number - 4002

    Hanamaki-shi, 025-0082, Japan

  • Site Number - 4003

    Narita-shi, 286-8520, Japan

  • Site Number - 4005

    Tokyo, 160-0023, Japan

  • Site Number - 4007

    Koshigaya-shi, 343-8555, Japan

  • Site Number - 4008

    Miyagi, 983-8520, Japan

  • Site Number - 4009

    Kawasaki-shi, 216-8511, Japan

  • Site Number - 4010

    Osaka, 534-0021, Japan

  • Site Number - 4011

    Matsuyama, 791-8026, Japan

  • Site Number - 4012

    Koriyama-shi, 963-8563, Japan

  • Site Number - 4013

    Higashimatsushima, 355-0005, Japan

  • Site Number - 4014

    Fuchu-shi, 183-0042, Japan

  • Site Number - 4015

    Yokohama, 236-0004, Japan

  • Site Number - 4016

    Yokohama, 222-0036, Japan

  • Site Number - 4019

    Yokohama, 230-8765, Japan

  • Site Number - 4020

    Asahikawa-shi, 078-8510, Japan

  • Site Number - 4501

    Seoul, 06351, South Korea

  • Site Number - 4505

    Daegu, 41944, South Korea

  • Site Number - 5001

    Buenos Aires, C1428AQK, Argentina

  • Site Number - 5002

    Buenos Aires, 4190, Argentina

  • Site Number - 5003

    Rosario, S2000, Argentina

  • Site Number - 5501

    Ribeirão Preto, 14051-140, Brazil

  • Site Number - 6002

    Genova, 16132, Italy

  • Site Number - 6003

    Milan, 20133, Italy

  • Site Number - 6004

    Bergamo, 24127, Italy

  • Site Number - 6007

    Naples, 80131, Italy

  • Site Number - 6503

    Jena, 7747, Germany

  • Site Number - 6505

    Gummersbach, 51643, Germany

  • Site Number - 6507

    Berlin, 10117, Germany

  • Site Number - 7002

    Sheffield, S102JF, United Kingdom

  • Site Number - 7552

    Kistarcsa, 2143, Hungary

  • Site Number - 8005

    Tbilisi, 0179, Georgia

  • Site Number - 9001

    Belgrade, 11000, Serbia

  • Site Number - 9002

    Niš, 1800, Serbia

  • Site Number -1001

    Austin, Texas, 78759, United States

  • Site Number -1002

    Carlsbad, California, 92011, United States

  • Site Number -1003

    Lexington, Kentucky, 40536, United States

  • Site Number -1004

    Cleveland, Ohio, 44195, United States

  • Site Number -1005

    Charlottesville, Virginia, 22908, United States

  • Site Number -1006

    Portland, Oregon, 97239, United States

  • Site Number -1007

    Clearwater, Florida, 33761, United States

  • Site Number -1009

    Irvine, California, 92697, United States

  • Site Number -1010

    Maitland, Florida, 32751, United States

  • Site Number -1011

    Fairway, Kansas, 66205, United States

  • Site Number -1013

    East Lansing, Michigan, 48824, United States

  • Site Number -1016

    Dallas, Texas, 75206, United States

  • Site Number -1022

    Phoenix, Arizona, 85028, United States

  • Site Number -1029

    Scottsdale, Arizona, 85251, United States

  • Site Number -1032

    San Francisco, California, 94143, United States

  • Site Number -3001

    Katowice, 40-123, Poland

  • Site Number -3002

    Krakow, 31-505, Poland

  • Site Number -3004

    Krakow, 31-324, Poland

  • Site Number -3006

    Poznan, 61-731, Poland

  • Site Number -3501

    Madrid, 028034, Spain

  • Site Number -3502

    Barcelona, 08195, Spain

  • Site Number -3505

    Barcelona, 8041, Spain

  • Site Number -6001

    Naples, 80131, Italy

  • Site Number -6006

    Brescia, 25123, Italy

  • Site Number -6502

    Würzburg, 97074, Germany

  • Site Number -6504

    Leipzig, 04103, Germany

  • Site Number -7501

    Târgu Mureş, 540136, Romania

  • Site Number -7502

    Constanța, 900628, Romania

  • Site Number -7503

    Timișoara, 300723, Romania

  • Site Number -7553

    Budapest, 1082, Hungary

  • Site Number -8001

    Tbilisi, 00160, Georgia

  • Site Number -8002

    Tbilisi, 00114, Georgia

  • Site Number -8003

    Tbilisi, 00186, Georgia

  • Site Number -8004

    Tbilisi, 00114, Georgia

  • Site Number- 5503

    Rio de Janeiro, 22640-100, Brazil

More trials for these conditions

Other studies related to the condition(s) this trial covers.