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

March 24, 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

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

240

Phase

  • 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 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

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
Intervention / Treatment
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

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

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
Percentage of Participants with Treatment Emergent Adverse Events (TEAEs)
Time Frame: Up to 76 Weeks
An adverse event (AE) is defined as any untoward medical occurrence in a participant who has either been administered a study drug or has undergone study procedures.
Up to 76 Weeks
Percentage of Participants With Clinically Significant Changes in Vital Sign Measurements
Time Frame: Up to 76 Weeks
Vital signs, including systolic and diastolic blood pressures, pulse rate, respiratory rate, and temperature will be obtained and recorded at specified timepoints. All vital sign measures will be obtained with the participant in the supine position and having rested for at least 5 minutes.
Up to 76 Weeks
Number of Participants with Clinically Significant Changes in Laboratory Results
Time Frame: Up to 76 Weeks
Blood samples will be collected at specified timepoints for the analysis of laboratory parameters including clinical chemistry, hematology and urinalysis.
Up to 76 Weeks
Percentage of participants with clinical laboratory-related TEAEs or treatment emergent laboratory abnormalities.
Time Frame: Up to 76 Weeks
Up to 76 Weeks

Collaborators and Investigators

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

Sponsor

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)

June 27, 2022

Primary Completion (Actual)

January 10, 2025

Study Completion (Estimated)

February 1, 2027

Study Registration Dates

First Submitted

May 26, 2022

First Submitted That Met QC Criteria

May 26, 2022

First Posted (Actual)

June 3, 2022

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 24, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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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