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

Purpose

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.

Condition

  • Graves' Disease

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Sex
All
Accepts 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. - Male or female participants aged ≥ 18 years. - Participants with diagnosis of GD who are hyperthyroid despite ATD treatment. - Other, more specific inclusion criteria are defined in the protocol.

Exclusion Criteria

  • Have previously been successfully treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. - Have an autoimmune disease other than GD requiring treatment that, in the Investigator's judgment, puts the participant at undue risk. - Have moderate-to-severe active thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation. - Additional exclusion criteria are defined in the protocol.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
IMVT-1402 Dose 1
  • Drug: IMVT-1402
    Dose 1 for 26 weeks
Experimental
IMVT-1402 Dose 2
  • Drug: IMVT-1402
    Dose 2 for 26 weeks
Placebo Comparator
Placebo
  • Drug: Placebo
    For 26 weeks

Recruiting Locations

Site Number - 1015
Tucson, Arizona 85710

Site Number -1014
Concord, California 94520

Site Number - 1013
Aurora, Colorado 80045

Site Number - 1024
Doral, Florida 33166

Site Number - 1008
Hialeah, Florida 33016

Site Number - 1000
Miami, Florida 33143

Site Number - 1020
Columbus, Georgia 31904

Site Number - 1022
Topeka, Kansas 66606

Site Number - 1030
Louisville, Kentucky 40202

Site Number - 1033
Jefferson City, Missouri 65109

Site Number - 1004
Kansas City, Missouri 64110

Site Number - 1019
St Louis, Missouri 63110

Site Number - 1012
Reno, Nevada 89511

Site Number - 1032
Long Island City, New York 11106

Site Number - 1027
New Hyde Park, New York 11434

Site Number - 1009
New York, New York 10022

Site Number - 1018
Williamsville, New York 14221

Site Number - 1010
Chapel Hill, North Carolina 27514

Site Number - 1026
Hickory, North Carolina 28601

Site Number - 1001
Morehead City, North Carolina 27577

Site Number - 1034
Raleigh, North Carolina 27612

Site Number - 1007
Oklahoma City, Oklahoma 73134

Site Number - 1017
Memphis, Tennessee 38119

Site Number - 1029
Dallas, Texas 75224

Site Number - 1002
El Paso, Texas 79935

Site Number - 1003
Fort Worth, Texas 76132

Site Number - 1031
Houston, Texas 77030

Site Number - 1028
Houston, Texas 77054

Site Number -1023
Irving, Texas 75031

Site Number - 1021
Irving, Texas 75039

Site Number - 1025
McKinney, Texas 75069

Site Number - 1011
San Antonio, Texas 78231

Site Number - 1016
Norfolk, Virginia 23510

More Details

Status
Recruiting
Sponsor
Immunovant Sciences GmbH

Study Contact

Central Study Contact
18007970414
clinicaltrials@immunovant.com