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Generalized Myasthenia GravisPhase 3NCT05403541

Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

A Phase 3 study testing Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly and Batoclimab 340 mg SC bi-weekly in people with Generalized Myasthenia Gravis, run by Immunovant Sciences GmbH at 93 sites in 16 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. 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?
Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly and Batoclimab 340 mg SC bi-weekly
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
233 participants
Where
93 sitesin 16 countries
Study dates
27 Jun 2022to 7 Aug 2026
Phase
Phase 3
Are there results?
None posted in the registry

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

  • Are ≥ 18 years of age at the Screening Visit.
  • Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
  • Have a QMG score ≥ 11 at the Screening and Baseline Visits.
  • Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
  • Additional inclusion criteria are defined in the protocol.

Who cannot join

  • Have experienced myasthenic crisis within 3 months of the Screening Visit.
  • Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
  • Have any active or untreated malignant thymoma.
  • 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.
  • 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.
  • Additional exclusion criteria are defined in the protocol.

Trial locations and contacts

93 sites in 16 countries.

93 sites in 16 countries

United States30 sites

  • Site Number - 1027

    Aurora, Colorado, 80045

  • Site Number -1001

    Austin, Texas, 78759

  • Site Number - 1021

    Buffalo, New York, 14203

  • Site Number -1002

    Carlsbad, California, 92011

  • Site Number - 1018

    Chapel Hill, North Carolina, 27599

  • Site Number -1005

    Charlottesville, Virginia, 22908

  • Site Number -1007

    Clearwater, Florida, 33761

  • Site Number -1004

    Cleveland, Ohio, 44195

  • Site Number -1016

    Dallas, Texas, 75206

  • Site Number - 1008

    Durham, North Carolina, 27710

  • Site Number -1013

    East Lansing, Michigan, 48824

  • Site Number -1011

    Fairway, Kansas, 66205

  • Site Number - 1034

    Houston, Texas, 77030

  • Site Number -1009

    Irvine, California, 92697

  • Site Number -1003

    Lexington, Kentucky, 40536

  • Site Number -1010

    Maitland, Florida, 32751

  • Site Number - 1026

    Memphis, Tennessee, 38120

  • Site Number - 1020

    Miami, Florida, 33136

  • Site Number - 1024

    Minneapolis, Minnesota, 55414

  • Site Number - 1025

    New Haven, Connecticut, 06519

  • Site Number - 1012

    Olive View, California, 91342

  • Site Number - 1019

    Orlando, Florida, 32806

  • Site Number - 1023

    Philadelphia, Pennsylvania, 19104

  • Site Number -1022

    Phoenix, Arizona, 85028

  • Site Number - 1028

    Port Charlotte, Florida, 33952

  • Site Number -1006

    Portland, Oregon, 97239

  • Site Number - 1014

    Round Rock, Texas, 78681

  • Site Number -1032

    San Francisco, California, 94143

  • Site Number -1029

    Scottsdale, Arizona, 85251

  • Site Number - 1015

    Tampa, Florida, 33612

Other trials in United States

Japan16 sites

  • Site Number - 4020

    Asahikawa-shi, 078-8510

  • Site Number - 4014

    Fuchu-shi, 183-0042

  • Site Number - 4002

    Hanamaki-shi, 025-0082

  • Site Number - 4013

    Higashimatsushima, 355-0005

  • Site Number - 4009

    Kawasaki-shi, 216-8511

  • Site Number - 4012

    Koriyama-shi, 963-8563

  • Site Number - 4007

    Koshigaya-shi, 343-8555

  • Site Number - 4011

    Matsuyama, 791-8026

  • Site Number - 4008

    Miyagi, 983-8520

  • Site Number - 4003

    Narita-shi, 286-8520

  • Site Number - 4010

    Osaka, 534-0021

  • Site Number - 4001

    Osaka, 589-8511

  • Site Number - 4005

    Tokyo, 160-0023

  • Site Number - 4016

    Yokohama, 222-0036

  • Site Number - 4019

    Yokohama, 230-8765

  • Site Number - 4015

    Yokohama, 236-0004

Other trials in Japan

Poland8 sites

  • Site Number - 3007

    Gdansk, 80-214

  • Site Number -3001

    Katowice, 40-123

  • Site Number -3004

    Krakow, 31-324

  • Site Number - 3003

    Krakow, 31-503

  • Site Number -3002

    Krakow, 31-505

  • Site Number - 3008

    Lublin, 20-701

  • Site Number -3006

    Poznan, 61-731

  • Site Number - 3005

    Warsaw, 01-684

Other trials in Poland

Italy6 sites

  • Site Number - 6004

    Bergamo, 24127

  • Site Number -6006

    Brescia, 25123

  • Site Number - 6002

    Genova, 16132

  • Site Number - 6003

    Milan, 20133

  • Site Number - 6007

    Naples, 80131

  • Site Number -6001

    Naples, 80131

Other trials in Italy

Georgia5 sites

  • Site Number -8002

    Tbilisi, 00114

  • Site Number -8004

    Tbilisi, 00114

  • Site Number -8001

    Tbilisi, 00160

  • Site Number -8003

    Tbilisi, 00186

  • Site Number - 8005

    Tbilisi, 0179

Other trials in Georgia

Germany5 sites

  • Site Number - 6507

    Berlin, 10117

  • Site Number - 6505

    Gummersbach, 51643

  • Site Number - 6503

    Jena, 7747

  • Site Number -6504

    Leipzig, 04103

  • Site Number -6502

    Würzburg, 97074

Other trials in Germany

Spain4 sites

  • Site Number -3502

    Barcelona, 08195

  • Site Number -3505

    Barcelona, 8041

  • Site Number -3501

    Madrid, 028034

  • Site Number - 3503

    Madrid, 28046

Other trials in Spain

Argentina3 sites

  • Site Number - 5002

    Buenos Aires, 4190

  • Site Number - 5001

    Buenos Aires, C1428AQK

  • Site Number - 5003

    Rosario, S2000

Other trials in Argentina

Canada3 sites

  • Site Number - 2004

    Montreal, Quebec, H3A 2B4

  • Site Number - 2002

    Toronto, Ontario, M5G 2C4

  • Site Number - 2003

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

Romania3 sites

  • Site Number -7502

    Constanța, 900628

  • Site Number -7501

    Târgu Mureş, 540136

  • Site Number -7503

    Timișoara, 300723

Other trials in Romania

Brazil2 sites

  • Site Number - 5501

    Ribeirão Preto, 14051-140

  • Site Number- 5503

    Rio de Janeiro, 22640-100

Other trials in Brazil

Hungary2 sites

  • Site Number -7553

    Budapest, 1082

  • Site Number - 7552

    Kistarcsa, 2143

Other trials in Hungary

Serbia2 sites

  • Site Number - 9001

    Belgrade, 11000

  • Site Number - 9002

    Niš, 1800

Other trials in Serbia

South Korea2 sites

  • Site Number - 4505

    Daegu, 41944

  • Site Number - 4501

    Seoul, 06351

Other trials in South Korea

Mexico1 site

  • Site Number - 2601

    Mexico City, 06700

Other trials in Mexico

United Kingdom1 site

  • Site Number - 7002

    Sheffield, S102JF

Other trials in United Kingdom

About this study

Official title: A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)

The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.

Being tested
Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly, Matching Placebo SC, Batoclimab 340 mg SC bi-weekly
Keywords
monoclonal antibody, batoclimab, IMVT-1401, Myasthenia Gravis, acetylcholine receptor, RVT-1401
Medical subject headings
Myasthenia Gravis

What participants receive

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

  • Batoclimab 680 mg SC weeklyDrug

    Also called IMVT-1401

    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

  • Batoclimab 340 mg SC weeklyDrug

    Also called IMVT-1401

    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

  • Matching Placebo SCDrug

    Placebo

  • Batoclimab 340 mg SC bi-weeklyDrug

    Also called IMVT-1401

    Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Study groups in NCT05403541
Study groupRoleWhat they receive
Batoclimab Induction Dose 1 (Period 1)ExperimentalNot described
Receives: Drug: Batoclimab 680 mg SC weekly
Batoclimab Induction Dose 2 (Period 1)ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Placebo Induction Dose (Period 1)Placebo comparatorNot described
Receives: Drug: Matching Placebo SC
Batoclimab Maintenance Dose 1 (Period 2)ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC weekly
Batoclimab Maintenance Dose 2 (Period 2)ExperimentalNot described
Receives: Drug: Batoclimab 340 mg SC bi-weekly
Placebo Maintenance Dose (Period 2)Placebo comparatorNot described
Receives: Drug: Matching Placebo SC

What is being measured

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

  1. Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants

    MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.

    Measured: Baseline (Day 1) to Week 12

Secondary outcomes (5)

  1. Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants

    QMG is clinician-reported assessment to evaluate muscle weakness in participants with MG. The QMG consists of 13 items ranging from 0 to 3 with 3 being the most severe. Total score ranges from 0 to 39, with higher scores representing greater impairment.

    Measured: Baseline (Day 1) to Week 12

  2. Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants

    Measured: Baseline (Week 12) to Week 24

  3. Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score

    Measured: Up to Week 12

  4. Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12

    Measured: Up to Week 12

  5. Change from Baseline in MG-ADL score in AChRAb- (AChRAb negative) participants

    Measured: Baseline (Day 1) to Week 12

Timeline

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

  1. First posted3 Jun 2022
  2. Study start27 Jun 2022
  3. Primary completion10 Jan 2025
  4. Study completion7 Aug 2026

Why it stopped: Sponsor Decision

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
233 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403541
Sponsor's protocol ID
IMVT-1401-3101
Status last verified
Sep 2026
First submitted
26 May 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Benatar M, Wiendl H, Nowak R, Zheng Y, Macias W. Batoclimab as induction and maintenance therapy in patients with myasthenia gravis: rationale and study design of a phase 3 clinical trial. BMJ Neurol Open. 2024 Jan 10;6(1):e000536. doi: 10.1136/bmjno-2023-000536. eCollection 2024.

    PubMed 38268752

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly and Batoclimab 340 mg SC bi-weekly in people with Generalized Myasthenia Gravis, run by Immunovant Sciences GmbH at 93 sites in 16 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 5 inclusion and 6 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: stopped early, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 93 sites in United States, Japan, Poland, Italy, Georgia and 11 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. Some participants in this study may receive a placebo. 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?

The study was stopped early (reason given: Sponsor Decision). Results are not available in the source record.

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 from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants (time frame: Baseline (Day 1) to Week 12). 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 NCT05403541, 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 14 Sep 2026.

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