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Batoclimab weekly

Phase 3

Generalized Myasthenia Gravis | Small molecule | Neurology |Immunovant, Inc.|Last Updated: Jun 5, 2026

Success Probability
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Market & Valuation
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMC
Total Trials1
Total Enrollment240
FDA Designations
No designations recorded
Clinical trial landscape

Batoclimab weekly · 2 trials · 2 indications

Phase 3 1Phase 2 1
NCT05403541Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia GravisGeneralized Myasthenia Gravis
ACTIVE NOT_RECRUITING240 Analytics
PHASE3ACTIVE NOT_RECRUITING
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Generalized Myasthenia GravisUnlock trial analytics
Study Endpoints
Primary Endpoints
Change from Baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in acetylcholine receptor (AChR) Ab seropositive (AChRAb+) participants
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.

Period 2, Cohort A: Proportion of participants who remain relapse-free at Week 36
Week 36

Relapse is defined as a worsening (increase) of \>=1 point on adjusted inflammatory neuropathy cause and treatment (AdjINCAT) score at any time point during Period 2 relative to Period 2 Baseline which is sustained at a Follow-Up visit 1 week later. The INCAT disability scale is a widely used and validated efficacy assessment of neurologic dysfunction in CIDP. Upper and lower limb dysfunction are each separately assessed on a scale of 0-5 and results are summed together for a total composite score of 0-10. Higher scores represent greater disability. The Adj INCAT disability score is identical to INCAT disability score with exception that changes in upper limb function from 0 (normal) to 1 (minor symptoms) and vice versa are excluded since minor symptoms in the fingers, which are implied by an upper limb score of 1, are not considered clinically significant in all participants. The Adj INCAT disability score will be used for participant selection and measurement of clinical response.

Secondary Endpoints
Change from Baseline in Quantitative Myasthenia Gravis (QMG) score in AChRAb+ participants
Baseline (Day 1) to Week 12
Change from Baseline in MG-ADL score for AChRAb+ randomized withdrawal participants
Baseline (Week 12) to Week 24
Percentage of AChRAb+ participants with greater than equal to (>=) 3-point improvement in QMG score
Up to Week 12
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Study Design & Arms
AllocationRANDOMIZED
MaskingTRIPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Batoclimab Induction Dose 1 (Period 1)EXPERIMENTAL -
Batoclimab Induction Dose 2 (Period 1)EXPERIMENTAL -
Placebo Induction Dose (Period 1)PLACEBO_COMPARATOR -
Batoclimab Maintenance Dose 1 (Period 2)EXPERIMENTAL -
Batoclimab Maintenance Dose 2 (Period 2)EXPERIMENTAL -
Placebo Maintenance Dose (Period 2)PLACEBO_COMPARATOR -
Treatment Period 1: Cohort A, Dose 1EXPERIMENTAL -
Treatment Period 1: Cohort A, Dose 2EXPERIMENTAL -
Treatment Period 1: Cohort B, Dose 1EXPERIMENTAL -
Treatment Period 1: Cohort B, Dose 2EXPERIMENTAL -
Treatment Period 1: Cohort C, Dose 1EXPERIMENTAL -
Treatment Period 1: Cohort C, Dose 2EXPERIMENTAL -
Treatment Period 1: Cohort D, Dose 1EXPERIMENTAL -
Treatment Period 1: Cohort D, Dose 2EXPERIMENTAL -
Withdrawal Period 2: Cohort A, Dose 2EXPERIMENTAL -
Withdrawal Period 2: Cohort A, PlaceboEXPERIMENTAL -
Withdrawal Period 2: Cohort B, Dose 2EXPERIMENTAL -
Withdrawal Period 2: Cohort B, PlaceboEXPERIMENTAL -
Withdrawal Period 2: Cohort C, Dose 2EXPERIMENTAL -
Withdrawal Period 2: Cohort C, PlaceboEXPERIMENTAL -
Withdrawal Period 2: Cohort D, Dose 2EXPERIMENTAL -
Withdrawal Period 2: Cohort D, PlaceboEXPERIMENTAL -
LTE Period: With Relapse in Period 2: Dose 1 and Dose 2EXPERIMENTALParticipants will receive Dose 1 for the initial 4 weeks only and Dose 2 for the remaining 48 weeks.
LTE Period: Without Relapse in Period 2: Dose 2EXPERIMENTALParticipants will receive Dose 2 for all 52 weeks.
Interventions
NameTypeDescription
Batoclimab 680 mg SC weeklyDRUGBatoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab 340 mg SC weeklyDRUGBatoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Matching Placebo SCDRUGPlacebo
Batoclimab 340 mg SC bi-weeklyDRUGBatoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Batoclimab 680 milligrams (mg) subcutaneous (SC) weeklyDRUGBatoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
PlaceboDRUGMatching placebo SC
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Eligibility Criteria
Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites93

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...

Countries:United StatesArgentinaBrazilCanadaGeorgiaGermanyHungaryItalyJapanMexicoPolandRomaniaSerbiaSouth KoreaSpainUnited KingdomBelgiumBulgariaDenmarkFinlandGreeceNorwayPortugalSlovakiaSweden
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Recent Changes (Last 90 Days)
LOWJun 5, 2026NCT05403541lastUpdatePostDate: changed
LOWJun 5, 2026NCT05403541lastUpdatePostDate: changed
LOWJun 5, 2026NCT05403541lastUpdatePostDate: changed
LOWJun 5, 2026NCT05403541lastUpdatePostDate: changed
LOWMay 26, 2026NCT05581199primaryCompletionDate: changed
LOWMay 26, 2026NCT05403541primaryCompletionDate: changed
LOWMay 24, 2026NCT05581199studyFirstPostDate: changed
LOWMay 24, 2026NCT05403541studyFirstPostDate: changed