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

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

  • Graves' Disease

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