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Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis

ConditionGeneralized Myasthenia Gravis
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-80
SponsorImmunovant Sciences GmbH

About this trial

The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures.

Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit

Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1)

Disqualifiers

Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit.

Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study

Have any active or untreated malignant thymoma

Trial design

Design model

Parallel

Treatments tested in this trial

  • IMVT-1402

    Drug

    • Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)

  • IMVT-1402

    Drug

    * Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3)

  • Placebo

    Drug

    • Placebo SC QW for 12 weeks (Period 1)

  • IMVT-1402

    Drug

    * Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)

Treatment groups

231 Participants
are divided into 3 treatment groups
Group A: Group 1: IMVT-1402 Dose 1Experimental treatment 1 intervention
Group B: Group 2: IMVT-1402 Dose 2Experimental treatment 1 intervention
Group C: Placebo/ IMVT-1402Placebo comparator 2 interventions

Trial outcomes

Primary outcomes

1

Change from Baseline in MG-ADL Score for Antibody-positive Participants

Time frame
Baseline to Week 12

Secondary outcomes

1

Change from Baseline in Quantitative Myasthenia Gravis (QMG) Score for Antibody-positive Participants

Time frame
Baseline to Week 12
2

Percentage of Antibody-positive Participants Achieving MG-ADL Score of 0 or 1

Time frame
Week 12
3

Percentage of Antibody-positive Participants with ≥50% Improvement in MG-ADL Score

Time frame
Baseline to Week 12

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Immunovant Sciences GmbH

Lead sponsor

Source ClinicalTrials.gov
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