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NCT Number: NCT05403541

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Generalized Myasthenia Gravis Autoimmune Diseases Autoimmune Diseases of the Nervous System Immune System Diseases Myasthenia Gravis Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Site Number - 5001, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Batoclimab 680 mg SC weekly

Drug

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

Other names: IMVT-1401

Batoclimab 340 mg SC weekly

Drug

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

Other names: IMVT-1401

Matching Placebo SC

Drug

Placebo

Batoclimab 340 mg SC bi-weekly

Drug

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

Other names: IMVT-1401

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

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

    Time frame: Baseline (Week 12) to Week 24

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

    Time frame: Up to Week 12

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

    Time frame: Up to Week 12

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

    Time frame: Baseline (Day 1) to Week 12

Sponsors and collaborators

Lead sponsor

Immunovant Sciences GmbH

Industry

Registry information

Official study 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)

Important dates

Study start
2022
Primary completion
2025
Study completion
2027
First posted
Jun 3, 2022
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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