Skip to main content
TrialFinder
TrialFinder is for informational purposes only and does not provide medical advice. Always talk to your doctor about whether a trial is right for you.
RECRUITINGPhase 3INTERVENTIONAL

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

A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

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.

Who May Be Eligible (Plain English)

Who May Qualify: - Participants with the ability to understand the requirements of the trial, provide written willing to sign a consent form, 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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)

Locations (20)

Site Number - 1041
Mobile, Alabama, United States
Site Number - 1017
Phoenix, Arizona, United States
Site Number - 1025
Scottsdale, Arizona, United States
Site Number - 1042
Tucson, Arizona, United States
Site Number - 1010
Carlsbad, California, United States
Site Number - 1028
Irvine, California, United States
Site Number - 1023
Los Angeles, California, United States
Site Number - 1029
Rancho Mirage, California, United States
Site Number - 1004
San Francisco, California, United States
Site Number - 1027
Fort Collins, Colorado, United States
Site Number - 1001
New Haven, Connecticut, United States
Site Number - 1024
Washington D.C., District of Columbia, United States
Site Number - 1006
Clearwater, Florida, United States
Site Number - 1037
Ormond Beach, Florida, United States
Site Number - 1002
Port Charlotte, Florida, United States
Site Number - 1050
Rockledge, Florida, United States
Site Number - 1007
Tampa, Florida, United States
Site Number - 1014
Atlanta, Georgia, United States
Site Number - 1043
Augusta, Georgia, United States
Site Number - 1022
Lexington, Kentucky, United States