A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease

Part of paid clinical trials in Tucson, Arizona.

Sponsor
Immunovant Sciences GmbH
Study ID
NCT07018323
Phase
PHASE2
Status
Recruiting

Conditions

  • Graves' Disease

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • IMVT-1402 — DRUG
    Dose 1 for 26 weeks
  • IMVT-1402 — DRUG
    Dose 2 for 26 weeks
  • Placebo — DRUG
    For 26 weeks

Study Details

This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b study to assess the efficacy, safety, and tolerability of IMVT-1402 in adult participants with Graves' disease (GD) who are hyperthyroid despite antithyroid drug (ATD) treatment.

Key Dates

Start date
Jun 19, 2025
Status verified
Jun 2026
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

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

Arms

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

Primary Outcome Measure

Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) [ Time Frame: Week 26 ]

Central Contacts

Locations (33)

FacilityCityStateZIPSite coordinators
Site Number - 1015TucsonArizona85710-
Site Number -1014ConcordCalifornia94520-
Site Number - 1013AuroraColorado80045-
Site Number - 1024DoralFlorida33166-
Site Number - 1008HialeahFlorida33016-
Site Number - 1000MiamiFlorida33143-
Site Number - 1020ColumbusGeorgia31904-
Site Number - 1022TopekaKansas66606-
Site Number - 1030LouisvilleKentucky40202-
Site Number - 1033Jefferson CityMissouri65109-
Site Number - 1004Kansas CityMissouri64110-
Site Number - 1019St LouisMissouri63110-
Site Number - 1012RenoNevada89511-
Site Number - 1032Long Island CityNew York11106-
Site Number - 1027New Hyde ParkNew York11434-
Site Number - 1009New YorkNew York10022-
Site Number - 1018WilliamsvilleNew York14221-
Site Number - 1010Chapel HillNorth Carolina27514-
Site Number - 1026HickoryNorth Carolina28601-
Site Number - 1001Morehead CityNorth Carolina27577-
Site Number - 1034RaleighNorth Carolina27612-
Site Number - 1007Oklahoma CityOklahoma73134-
Site Number - 1017MemphisTennessee38119-
Site Number - 1029DallasTexas75224-
Site Number - 1002El PasoTexas79935-
Site Number - 1003Fort WorthTexas76132-
Site Number - 1028HoustonTexas77054-
Site Number - 1031HoustonTexas77030-
Site Number - 1021IrvingTexas75039-
Site Number -1023IrvingTexas75031-
Site Number - 1025McKinneyTexas75069-
Site Number - 1011San AntonioTexas78231-
Site Number - 1016NorfolkVirginia23510-

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