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

Part of paid clinical trials in Huntsville, Alabama.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT07039916
Phase
PHASE3
Status
Recruiting
Apply to this trial

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • 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)

Study Details

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.

Key Dates

Start date
May 27, 2025
Status verified
May 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
231 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Group 1: IMVT-1402 Dose 1
  • Experimental: Group 2: IMVT-1402 Dose 2
  • Placebo Comparator: Placebo/ IMVT-1402

Primary Outcome Measure

Change from Baseline in MG-ADL Score for Antibody-positive Participants [ Time Frame: Baseline to Week 12 ]

Central Contacts

Locations (46)

FacilityCityStateZIPSite coordinators
Site Number - 1056HuntsvilleAlabama35801-
Site Number - 1041MobileAlabama36604-
Site Number - 1017PhoenixArizona85028-
Site Number - 1025ScottsdaleArizona85251-
Site Number - 1042TucsonArizona85718-
Site Number - 1010CarlsbadCalifornia92011-
Site Number - 1028IrvineCalifornia92697-
Site Number - 1023Los AngelesCalifornia90033-
Site Number - 1029Rancho MirageCalifornia92270-
Site Number - 1004San FranciscoCalifornia94143-
Site Number - 1027Fort CollinsColorado80528-
Site Number - 1001New HavenConnecticut06510-
Site Number - 1024Washington D.C.District of Columbia20010-
Site Number - 1006ClearwaterFlorida33761-
Site Number - 1037Ormond BeachFlorida32174-
Site Number - 1002Port CharlotteFlorida33952-
Site Number - 1050RockledgeFlorida32955-
Site Number - 1007TampaFlorida33612-
Site Number - 1014AtlantaGeorgia30329-
Site Number - 1043AugustaGeorgia30912-
Site Number - 1022LexingtonKentucky40536-0284-
Site Number - 1032NicholasvilleKentucky40356-
Site Number - 1046New OrleansLouisiana70121-
Site Number - 1049FoxboroughMassachusetts02035-
Site Number - 1026DetroitMichigan48201-
Site Number - 1005East LansingMichigan48824-
Site Number - 1018OmahaNebraska68198-
Site Number - 1019TotowaNew Jersey07512-
Site Number - 1034New YorkNew York10065-
Site Number - 1036New YorkNew York10021-
Site Number - 1020Chapel HillNorth Carolina27599-
Site Number - 1013DurhamNorth Carolina27710-
Site Number - 1044RaleighNorth Carolina27607-
Site Number - 1038CincinnatiOhio45221-
Site Number - 1045Oklahoma CityOklahoma73104-
Site Number - 1011YukonOklahoma73099-
Site Number - 1031EugeneOregon97477-
Site Number - 1015CharlestonSouth Carolina29486-
Site Number - 1030CharlestonSouth Carolina29425-
Site Number - 1021MemphisTennessee38120-
Site Number - 1003DallasTexas75206-
Site Number - 1047DentonTexas76208-
Site Number - 1048LubbockTexas79414-
Site Number - 1009CharlottesvilleVirginia22903-
Site Number - 1040RichmondVirginia23298-
Site Number - 1035GreenfieldWisconsin53228-

Find similar trials in Huntsville, AL

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Site Number - 1056· Huntsville, ALSite Number - 1041· Mobile, ALSite Number - 1017· Phoenix, AZSite Number - 1025· Scottsdale, AZSite Number - 1042· Tucson, AZSite Number - 1010· Carlsbad, CA

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