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Purpose

This is a 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. The primary objective of this study is to evaluate the efficacy of IMVT-1402 versus placebo as assessed by T3 (total triiodothyronine [T3] or free triiodothyronine [FT3]), free thyroxine (FT4), thyroid-stimulating hormone (TSH), and ATD dose at Week 26.

Condition

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
Group 1 Period 1 and 2: IMVT-1402
  • Drug: IMVT-1402
    600 mg SC QW for 52 weeks
Experimental
Group 2 Period 1 and 2: IMVT-1402
  • Drug: IMVT-1402
    600 mg SC QW for 52 weeks
Experimental
Group 2 Period 1: IMVT-1402 and Period 2: Placebo
  • Drug: IMVT-1402
    600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks
Placebo Comparator
Group 3 Period 1 and 2: Placebo
  • Drug: Placebo
    SC QW for 52 weeks

Recruiting Locations

Site Number - 1036
Phoenix, Arizona 85015

Site Number - 1061
Huntington Beach, California 92647

Site Number - 1001
Los Angeles, California 90033

Site Number - 1047
Los Angeles, California 90095

Site Number - 1062
Orange, California 92868

Site Number - 1046
Sacramento, California 95816

Site Number - 1034
San Francisco, California 94143

Site Number - 1005
Torrance, California 90502

Site Number - 1013
Englewood, Colorado 80113

Site Number - 1010
Newark, Delaware 19713

Site Number - 1040
Washington D.C., District of Columbia 20010

Site Number - 1029
Clearwater, Florida 33756

Site Number - 1055
Jacksonville, Florida 32204-1177

Site Number - 1056
Jacksonville, Florida 32216

Site Number - 1028
Miami, Florida 33136

Site Number - 1065
Miami, Florida 33186

Site Number - 1064
Ocoee, Florida 34761

Site Number - 1011
Orlando, Florida 32819

Site Number - 1016
Port Charlotte, Florida 33952

Site Number - 1012
West Palm Beach, Florida 33401

Site Number - 1038
Atlanta, Georgia 30318

Site Number - 1053
Macon, Georgia 31210

Site Number - 1020
Stockbridge, Georgia 30281

Site Number - 1027
Indianapolis, Indiana 46202

Site Number - 1041
Kansas City, Kansas 66210

Site Number - 1045
Bowling Green, Kentucky 42101

Site Number - 1054
Florence, Kentucky 41042

Site Number - 1063
Metairie, Louisiana 70006

Site Number - 1022
New Orleans, Louisiana 70112

Site Number - 1048
Shreveport, Louisiana 71103

Site Number - 1023
Baltimore, Maryland 21287

Site Number - 1026
Boston, Massachusetts 02114

Site Number - 1018
Farmington Hills, Michigan 48334

Site Number - 1069
Flint, Michigan 48532

Site Number - 1008
Rochester, Minnesota 55905

Site Number - 1068
Gulfport, Mississippi 39501

Site Number - 1017
Omaha, Nebraska 68105

Site Number - 1007
Las Vegas, Nevada 89148

Site Number - 1050
Monroe, New York 10950

Site Number - 1051
Asheville, North Carolina 28803

Site Number - 1060
Wilmington, North Carolina 28401

Site Number - 1057
Canton, Ohio 44718

Site Number - 1003
Portland, Oregon 97035

Site Number - 1043
Pottstown, Pennsylvania 19464

Site Number - 1015
Summerville, South Carolina 29485

Site Number - 1042
Chattanooga, Tennessee 37421

Site Number - 1066
Nashville, Tennessee 37203

Site Number - 1049
Nashville, Tennessee 37212

Site Number - 1002
Austin, Texas 78731

Site Number - 1067
Bellaire, Texas 77401

Site Number - 1019
Dallas, Texas 75208

Site Number - 1071
Houston, Texas 77089

Site Number - 1004
Mesquite, Texas 75149

Site Number - 1009
Round Rock, Texas 78681

Site Number - 1014
San Antonio, Texas 78215

Site Number - 1052
San Antonio, Texas 78240

Site Number - 1030
Salt Lake City, Utah 84108

Site Number - 1070
Sandy City, Utah 84093

Site Number - 1058
San Juan, Puerto Rico 00907

More Details

Status
Recruiting
Sponsor
Immunovant Sciences GmbH

Study Contact

Central Study Contact
18007970414
clinicaltrials@immunovant.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.