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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

  • Have documented diagnosis of GD. - Have a TSH value < 0.1 mIU/L as assessed by the local laboratory at the Screening Visit. - Meet one of the following at the Screening Visit: - Have been on ATD for ≥ 3 months in the period immediately preceding the Screening Visit and both of the following: - Are on ATD at the Screening Visit with an ATD dose of ≥ 20 mg/day methimazole or equivalent for the 4-week period immediately preceding the Screening Visit. - Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization. - Have been on ATD for ≥ 6 months in the period immediately preceding the Screening Visit and all of the following: - Have been treated with ≥ 15 mg/day methimazole or equivalent at any point during the participant's treatment history. - Are on ATD at the Screening Visit with an ATD dose a specified amount of methimazole or equivalent for the 4-week period immediately preceding the Screening Visit. - Are anticipated to be on a stable dose of ATD for the 4-week period immediately preceding Randomization. Additional inclusion criteria are defined in the protocol.

Exclusion Criteria

  • Have previously been treated with radioactive iodine (RAI) therapy or have undergone total thyroidectomy. - Have a T3 (Total T3 or FT3, as available and per standard of care at local laboratory) or FT4 value < lower limit of normal (LLN) as assessed by the local laboratory at the Screening Visit. - Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within 6 weeks of the Screening Visit. - Have a history of hyperthyroidism not caused by GD (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within 6 months of the Screening Visit. - 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 - 1032
Phoenix 5308655, Arizona 5551752 85006

Site Number - 1036
Phoenix 5308655, Arizona 5551752 85015

Site Number - 1001
Los Angeles 5368361, California 5332921 90033

Site Number - 1034
San Francisco 5391959, California 5332921 94143

Site Number - 1035
Santa Clarita 5393049, California 5332921 91321

Site Number - 1005
Torrance 5403022, California 5332921 90502

Site Number - 1013
Englewood 5421250, Colorado 5417618 80113

Site Number - 1010
Newark 4143861, Delaware 4142224 19713

Site Number - 1029
Clearwater 4151316, Florida 4155751 33756

Site Number - 1028
Miami 4164138, Florida 4155751 33136

Site Number - 1011
Orlando 4167147, Florida 4155751 32819

Site Number - 1016
Port Charlotte 4169130, Florida 4155751 33952

Site Number - 1012
West Palm Beach 4177887, Florida 4155751 33401

Site Number - 1038
Atlanta 4180439, Georgia 4197000 30318

Site Number - 1020
Stockbridge 4224681, Georgia 4197000 30281

Site Number - 1027
Indianapolis 4259418, Indiana 4921868 46202

Site Number - 1022
New Orleans 4335045, Louisiana 4331987 70112

Site Number - 1023
Baltimore 4347778, Maryland 4361885 21287

Site Number - 1026
Boston 4930956, Massachusetts 6254926 02114

Site Number - 1018
Farmington Hills 4992523, Michigan 5001836 48334

Site Number - 1008
Rochester 5043473, Minnesota 5037779 55905

Site Number - 1017
Omaha 5074472, Nebraska 5073708 68105

Site Number - 1007
Las Vegas 5506956, Nevada 5509151 89148

Site Number - 1003
Portland 5746545, Oregon 5744337 97035

Site Number - 1033
Philadelphia 4560349, Pennsylvania 6254927 19140

Site Number - 1015
Summerville 4597919, South Carolina 4597040 29485

Site Number - 1042
Chattanooga 4612862, Tennessee 4662168 37421

Site Number - 1002
Austin 4671654, Texas 4736286 78731

Site Number - 1019
Dallas 4684888, Texas 4736286 75208

Site Number - 1031
Dallas 4684888, Texas 4736286 75231

Site Number - 1004
Mesquite 4710826, Texas 4736286 75149

Site Number - 1009
Round Rock 4724129, Texas 4736286 78681

Site Number - 1014
San Antonio 4726206, Texas 4736286 78215

Site Number - 1030
Salt Lake City 5780993, Utah 5549030 84108

Site Number - 1037
San Juan 4568127, Puerto Rico 00921-3313

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.