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Clinical Trials in Poland / NCT07039916
Recruiting Phase 3

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

NCT07039916 · tracked via the Priya Life Science Poland tracker
Sponsor
Immunovant Sciences GmbH
Phase
Phase 3
Started
2025-05-27
Last updated
2026-07-30

Condition(s) studied

Generalized Myasthenia Gravis

Investigational drug(s) / intervention(s)

IMVT-1402 →IMVT-1402 →PlaceboIMVT-1402 →

IMVT-1402: • Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)

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)

Placebo: • Placebo SC QW for 12 weeks (Period 1)

IMVT-1402: * Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria: * 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) Additional inclusion criteria are defined in the protocol. Exclusion Criteria: * 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 Additional exclusion criteria are defined in the protocol.

Primary outcome measure(s)

  • Change from Baseline in MG-ADL Score for Antibody-positive Participants — Baseline to Week 12

Trial sites (88)

FacilityCityRegionStatus
Site Number - 1056 Huntsville Alabama Recruiting
Site Number - 1041 Mobile Alabama Recruiting
Site Number - 1017 Phoenix Arizona Recruiting
Site Number - 1025 Scottsdale Arizona Recruiting
Site Number - 1042 Tucson Arizona Recruiting
Site Number - 1010 Carlsbad California Recruiting
Site Number - 1028 Irvine California Recruiting
Site Number - 1023 Los Angeles California Recruiting
Site Number - 1029 Rancho Mirage California Recruiting
Site Number - 1004 San Francisco California Recruiting
Site Number - 1027 Fort Collins Colorado Recruiting
Site Number - 1001 New Haven Connecticut Recruiting
Site Number - 1024 Washington D.C. District of Columbia Recruiting
Site Number - 1006 Clearwater Florida Recruiting
Site Number - 1037 Ormond Beach Florida Recruiting
Site Number - 1002 Port Charlotte Florida Recruiting
Site Number - 1050 Rockledge Florida Recruiting
Site Number - 1007 Tampa Florida Recruiting
Site Number - 1014 Atlanta Georgia Recruiting
Site Number - 1043 Augusta Georgia Recruiting
Site Number - 1054 Schaumburg Illinois Recruiting
Site Number - 1022 Lexington Kentucky Recruiting
Site Number - 1032 Nicholasville Kentucky Recruiting
Site Number - 1046 New Orleans Louisiana Recruiting
Site Number - 1049 Foxborough Massachusetts Recruiting
Site Number - 1026 Detroit Michigan Recruiting
Site Number - 1005 East Lansing Michigan Recruiting
Site Number - 1018 Omaha Nebraska Recruiting
Site Number - 1019 Totowa New Jersey Recruiting
Site Number - 1036 New York New York Recruiting
Site Number - 1034 New York New York Recruiting
Site Number - 1020 Chapel Hill North Carolina Recruiting
Site Number - 1013 Durham North Carolina Recruiting
Site Number - 1044 Raleigh North Carolina Recruiting
Site Number - 1038 Cincinnati Ohio Recruiting
Site Number - 1045 Oklahoma City Oklahoma Recruiting
Site Number - 1011 Yukon Oklahoma Recruiting
Site Number - 1031 Eugene Oregon Recruiting
Site Number - 1030 Charleston South Carolina Recruiting
Site Number - 1015 Charleston South Carolina Recruiting

+ 48 more sites — see the full list on the official registry below.

More Immunovant Sciences GmbH trials in Poland

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation
Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity Active, not recruiting
A Study to Assess the Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) Active, not recruiting
A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis Active, not recruiting
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease Recruiting

Other trials for the same condition

A Study to Test How Safe Pozelimab and Cemdisiran Combination Therapy and Cemdisiran Alone Are and How Well They Work in Adult Patients With Generalized Myasthenia Gravis Active, not recruiting
An Open-label Extension Study to Evaluate Subcutaneous Zilucoplan in Pediatric Participants With Generalized Myasthenia Gravis Enrolling by invitation
Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of Efgartigimod Administered Intravenously in Children With Generalized Myasthenia Gravis Recruiting
A Study of Efgartigimod PH20 SC in Children Between 2 and Less Than 18 Years of Age With Generalized Myasthenia Gravis Recruiting
A Study to Investigate the Efficacy, Safety and Tolerability of Remibrutinib Versus Placebo in Adult Patients With Generalized Myasthenia Gravis Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07039916 on ClinicalTrials.gov ↗ ← All trials in Poland