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

June 3, 2026 updated by: Immunovant Sciences GmbH

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
240

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina, 4190
        • Site Number - 5002
      • Buenos Aires, Argentina, C1428AQK
        • Site Number - 5001
      • Rosario, Argentina, S2000
        • Site Number - 5003
  • Brazil
      • Ribeirão Preto, Brazil, 14051-140
        • Site Number - 5501
      • Rio de Janeiro, Brazil, 22640-100
        • Site Number- 5503
  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • Site Number - 2003
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Site Number - 2002
    • Quebec
      • Montreal, Quebec, Canada, H3A 2B4
        • Site Number - 2004
  • Georgia
      • Tbilisi, Georgia, 00114
        • Site Number -8002
      • Tbilisi, Georgia, 00114
        • Site Number -8004
      • Tbilisi, Georgia, 00160
        • Site Number -8001
      • Tbilisi, Georgia, 00186
        • Site Number -8003
      • Tbilisi, Georgia, 0179
        • Site Number - 8005
  • Germany
      • Berlin, Germany, 10117
        • Site Number - 6507
      • Gummersbach, Germany, 51643
        • Site Number - 6505
      • Jena, Germany, 7747
        • Site Number - 6503
      • Leipzig, Germany, 04103
        • Site Number -6504
      • Würzburg, Germany, 97074
        • Site Number -6502
  • Hungary
      • Budapest, Hungary, 1082
        • Site Number -7553
      • Kistarcsa, Hungary, 2143
        • Site Number - 7552
  • Italy
      • Bergamo, Italy, 24127
        • Site Number - 6004
      • Brescia, Italy, 25123
        • Site Number -6006
      • Genova, Italy, 16132
        • Site Number - 6002
      • Milan, Italy, 20133
        • Site Number - 6003
      • Naples, Italy, 80131
        • Site Number - 6007
      • Naples, Italy, 80131
        • Site Number -6001
  • Japan
      • Asahikawa-shi, Japan, 078-8510
        • Site Number - 4020
      • Fuchu-shi, Japan, 183-0042
        • Site Number - 4014
      • Hanamaki-shi, Japan, 025-0082
        • Site Number - 4002
      • Higashimatsushima, Japan, 355-0005
        • Site Number - 4013
      • Kawasaki-shi, Japan, 216-8511
        • Site Number - 4009
      • Koriyama-shi, Japan, 963-8563
        • Site Number - 4012
      • Koshigaya-shi, Japan, 343-8555
        • Site Number - 4007
      • Matsuyama, Japan, 791-8026
        • Site Number - 4011
      • Miyagi, Japan, 983-8520
        • Site Number - 4008
      • Narita-shi, Japan, 286-8520
        • Site Number - 4003
      • Osaka, Japan, 534-0021
        • Site Number - 4010
      • Osaka, Japan, 589-8511
        • Site Number - 4001
      • Tokyo, Japan, 160-0023
        • Site Number - 4005
      • Yokohama, Japan, 236-0004
        • Site Number - 4015
      • Yokohama, Japan, 222-0036
        • Site Number - 4016
      • Yokohama, Japan, 230-8765
        • Site Number - 4019
  • Mexico
      • Mexico City, Mexico, 06700
        • Site Number - 2601
  • Poland
      • Gdansk, Poland, 80-214
        • Site Number - 3007
      • Katowice, Poland, 40-123
        • Site Number -3001
      • Krakow, Poland, 31-324
        • Site Number -3004
      • Krakow, Poland, 31-503
        • Site Number - 3003
      • Krakow, Poland, 31-505
        • Site Number -3002
      • Lublin, Poland, 20-701
        • Site Number - 3008
      • Poznan, Poland, 61-731
        • Site Number -3006
      • Warsaw, Poland, 01-684
        • Site Number - 3005
  • Romania
      • Constanța, Romania, 900628
        • Site Number -7502
      • Timișoara, Romania, 300723
        • Site Number -7503
      • Târgu Mureş, Romania, 540136
        • Site Number -7501
  • Serbia
      • Belgrade, Serbia, 11000
        • Site Number - 9001
      • Niš, Serbia, 1800
        • Site Number - 9002
  • South Korea
      • Daegu, South Korea, 41944
        • Site Number - 4505
      • Seoul, South Korea, 06351
        • Site Number - 4501
  • Spain
      • Barcelona, Spain, 08195
        • Site Number -3502
      • Barcelona, Spain, 8041
        • Site Number -3505
      • Madrid, Spain, 028034
        • Site Number -3501
      • Madrid, Spain, 28046
        • Site Number - 3503
  • United Kingdom
      • Sheffield, United Kingdom, S102JF
        • Site Number - 7002
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85028
        • Site Number -1022
      • Scottsdale, Arizona, United States, 85251
        • Site Number -1029
    • California
      • Carlsbad, California, United States, 92011
        • Site Number -1002
      • Irvine, California, United States, 92697
        • Site Number -1009
      • Olive View, California, United States, 91342
        • Site Number - 1012
      • San Francisco, California, United States, 94143
        • Site Number -1032
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Site Number - 1027
    • Connecticut
      • New Haven, Connecticut, United States, 06519
        • Site Number - 1025
    • Florida
      • Clearwater, Florida, United States, 33761
        • Site Number -1007
      • Maitland, Florida, United States, 32751
        • Site Number -1010
      • Miami, Florida, United States, 33136
        • Site Number - 1020
      • Orlando, Florida, United States, 32806
        • Site Number - 1019
      • Port Charlotte, Florida, United States, 33952
        • Site Number - 1028
      • Tampa, Florida, United States, 33612
        • Site Number - 1015
    • Kansas
      • Fairway, Kansas, United States, 66205
        • Site Number -1011
    • Kentucky
      • Lexington, Kentucky, United States, 40536
        • Site Number -1003
    • Michigan
      • East Lansing, Michigan, United States, 48824
        • Site Number -1013
    • Minnesota
      • Minneapolis, Minnesota, United States, 55414
        • Site Number - 1024
    • New York
      • Buffalo, New York, United States, 14203
        • Site Number - 1021
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Site Number - 1018
      • Durham, North Carolina, United States, 27710
        • Site Number - 1008
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Site Number -1004
    • Oregon
      • Portland, Oregon, United States, 97239
        • Site Number -1006
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Site Number - 1023
    • Tennessee
      • Memphis, Tennessee, United States, 38120
        • Site Number - 1026
    • Texas
      • Austin, Texas, United States, 78759
        • Site Number -1001
      • Dallas, Texas, United States, 75206
        • Site Number -1016
      • Houston, Texas, United States, 77030
        • Site Number - 1034
      • Round Rock, Texas, United States, 78681
        • Site Number - 1014
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Site Number -1005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Batoclimab Induction Dose 1 (Period 1)
Drug: Batoclimab 680 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Batoclimab Induction Dose 2 (Period 1)
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Placebo Comparator: Placebo Induction Dose (Period 1)
Drug: Matching Placebo SC
Placebo
Experimental: Batoclimab Maintenance Dose 1 (Period 2)
Drug: Batoclimab 340 mg SC weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Experimental: Batoclimab Maintenance Dose 2 (Period 2)
Drug: Batoclimab 340 mg SC bi-weekly
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Other Names:
  • IMVT-1401
Placebo Comparator: Placebo Maintenance Dose (Period 2)
Drug: Matching Placebo SC
Placebo

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
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.
Baseline (Day 1) to Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants
Time Frame: Baseline (Day 1) to Week 12
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.
Baseline (Day 1) to Week 12
Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants
Time Frame: Baseline (Week 12) to Week 24
Baseline (Week 12) to Week 24
Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score
Time Frame: Up to Week 12
Up to Week 12
Percentage of AChRAb+ participants achieving MG-ADL score of 0 or 1 by Week 12
Time Frame: Up to Week 12
Up to Week 12
Change from Baseline in MG-ADL score in AChRAb- (AChRAb negative) participants
Time Frame: Baseline (Day 1) to Week 12
Baseline (Day 1) to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Immunovant Sciences GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 27, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 10, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 3, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 5, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 3, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IMVT-1401-3101

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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