Recruiting

Phase 2

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

Sponsor:

Immunovant Sciences GmbH

Code:

NCT06727604

Conditions

Graves' Disease

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

IMVT-1402

Placebo

Study Details

Brief summary:

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.

Conditions

Graves' Disease

Study ID

NCT06727604

Start date

Dec 17, 2024

Status verified date

Aug, 2026

Completion date

Jun, 2028

Anticipated

Primary completion date

Jun, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Enrollment

240 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group 1 Period 1 and 2: IMVT-1402

experimental: Group 2 Period 1 and 2: IMVT-1402

experimental: Group 2 Period 1: IMVT-1402 and Period 2: Placebo

placebo comparator: Group 3 Period 1 and 2: Placebo

Interventions

IMVT-1402

600 mg SC QW for 52 weeks

IMVT-1402

600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks

Placebo

SC QW for 52 weeks

Primary outcome measure

Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26 [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Central Study Contact

18007970414 clinicaltrials@immunovant.com

Locations

Site Number - 1036

Recruiting

Phoenix, Arizona, United States, 85015

Site Number - 1061

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Huntington Beach, California, United States, 92647

Site Number - 1001

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Los Angeles, California, United States, 90033

Site Number - 1047

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Los Angeles, California, United States, 90095

Site Number - 1062

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Orange, California, United States, 92868

Site Number - 1046

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Sacramento, California, United States, 95816

Site Number - 1034

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San Francisco, California, United States, 94143

Site Number - 1005

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Torrance, California, United States, 90502

Site Number - 1013

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Englewood, Colorado, United States, 80113

Site Number - 1010

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Newark, Delaware, United States, 19713

Site Number - 1040

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Washington D.C., District of Columbia, United States, 20010

Site Number - 1029

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Clearwater, Florida, United States, 33756

Site Number - 1055

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Jacksonville, Florida, United States, 32204-1177

Site Number - 1056

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Jacksonville, Florida, United States, 32216

Site Number - 1028

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Miami, Florida, United States, 33136

Site Number - 1065

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Miami, Florida, United States, 33186

Site Number - 1064

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Ocoee, Florida, United States, 34761

Site Number - 1016

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Port Charlotte, Florida, United States, 33952

Site Number - 1038

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Atlanta, Georgia, United States, 30318

Site Number - 1053

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Macon, Georgia, United States, 31210

Site Number - 1027

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Indianapolis, Indiana, United States, 46202

Site Number - 1041

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Kansas City, Kansas, United States, 66210

Site Number - 1045

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Bowling Green, Kentucky, United States, 42101

Site Number - 1054

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Florence, Kentucky, United States, 41042

Site Number - 1063

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Metairie, Louisiana, United States, 70006

Site Number - 1022

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New Orleans, Louisiana, United States, 70112

Site Number - 1048

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Shreveport, Louisiana, United States, 71103

Site Number - 1023

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Baltimore, Maryland, United States, 21287

Site Number - 1026

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Boston, Massachusetts, United States, 02114

Site Number - 1018

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Farmington Hills, Michigan, United States, 48334

Site Number - 1069

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Flint, Michigan, United States, 48532

Site Number - 1008

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Rochester, Minnesota, United States, 55905

Site Number - 1068

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Gulfport, Mississippi, United States, 39501

Site Number - 1017

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Omaha, Nebraska, United States, 68105

Site Number - 1007

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Las Vegas, Nevada, United States, 89148

Site Number - 1050

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Monroe, New York, United States, 10950

Site Number - 1051

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Asheville, North Carolina, United States, 28803

Site Number - 1060

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Wilmington, North Carolina, United States, 28401

Site Number - 1057

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Canton, Ohio, United States, 44718

Site Number - 1003

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Portland, Oregon, United States, 97035

Site Number - 1043

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Pottstown, Pennsylvania, United States, 19464

Site Number - 1015

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Summerville, South Carolina, United States, 29485

Site Number - 1042

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Chattanooga, Tennessee, United States, 37421

Site Number - 1066

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Nashville, Tennessee, United States, 37203

Site Number - 1049

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Nashville, Tennessee, United States, 37212

Site Number - 1002

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Austin, Texas, United States, 78731

Site Number - 1067

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Bellaire, Texas, United States, 77401

Site Number - 1019

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Dallas, Texas, United States, 75208

Site Number - 1071

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Houston, Texas, United States, 77089

Site Number - 1004

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Mesquite, Texas, United States, 75149

Site Number - 1009

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Round Rock, Texas, United States, 78681

Site Number - 1014

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San Antonio, Texas, United States, 78215

Site Number - 1052

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San Antonio, Texas, United States, 78240

Site Number - 1030

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Salt Lake City, Utah, United States, 84108

Site Number - 1070

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Sandy City, Utah, United States, 84093

More Information

Sponsor

Immunovant Sciences GmbH

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

IMVT-1402
Anti Thyroid Drug
Hyperthyroidism
Autoimmune thyroid disease
Imeroprubart

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Immunovant Sciences GmbH on 2026-08-25.