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

NCT07039916 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2026-05-22

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

IMVT-1402

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

DRUG

IMVT-1402

* 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)

DRUG

Placebo

• Placebo SC QW for 12 weeks (Period 1)

DRUG

IMVT-1402

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

Sponsors & Collaborators

  • Immunovant Sciences GmbH

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-27
Primary Completion
2027-12-31
Completion
2028-12-31
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Czechia
  • Denmark
  • Georgia
  • Germany
  • Greece
  • Hungary
  • Italy
  • Poland
  • Romania
  • Serbia
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07039916 on ClinicalTrials.gov