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:

NCT07018323

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 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.

Conditions

Graves' Disease

Study ID

NCT07018323

Start date

Jun 19, 2025

Status verified date

Aug, 2026

Completion date

May, 2027

Anticipated

Primary completion date

May, 2027

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

210 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: IMVT-1402 Dose 1

experimental: IMVT-1402 Dose 2

placebo comparator: Placebo

Interventions

IMVT-1402

Dose 1 for 26 weeks

IMVT-1402

Dose 2 for 26 weeks

Placebo

For 26 weeks

Primary outcome measure

Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Central Study Contact

18007970414 clinicaltrials@immunovant.com

Locations

Site Number - 1015

Recruiting

Tucson, Arizona, United States, 85710

Site Number -1014

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Concord, California, United States, 94520

Site Number - 1013

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Aurora, Colorado, United States, 80045

Site Number - 1024

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Doral, Florida, United States, 33166

Site Number - 1008

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Hialeah, Florida, United States, 33016

Site Number - 1000

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Miami, Florida, United States, 33143

Site Number - 1020

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Columbus, Georgia, United States, 31904

Site Number - 1022

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Topeka, Kansas, United States, 66606

Site Number - 1030

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Louisville, Kentucky, United States, 40202

Site Number - 1033

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Jefferson City, Missouri, United States, 65109

Site Number - 1004

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Kansas City, Missouri, United States, 64110

Site Number - 1019

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St Louis, Missouri, United States, 63110

Site Number - 1012

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Reno, Nevada, United States, 89511

Site Number - 1032

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Long Island City, New York, United States, 11106

Site Number - 1027

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New Hyde Park, New York, United States, 11434

Site Number - 1009

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New York, New York, United States, 10022

Site Number - 1018

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Williamsville, New York, United States, 14221

Site Number - 1010

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Chapel Hill, North Carolina, United States, 27514

Site Number - 1026

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Hickory, North Carolina, United States, 28601

Site Number - 1001

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Morehead City, North Carolina, United States, 27577

Site Number - 1034

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Raleigh, North Carolina, United States, 27612

Site Number - 1007

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Oklahoma City, Oklahoma, United States, 73134

Site Number - 1017

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Memphis, Tennessee, United States, 38119

Site Number - 1029

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Dallas, Texas, United States, 75224

Site Number - 1002

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El Paso, Texas, United States, 79935

Site Number - 1003

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Fort Worth, Texas, United States, 76132

Site Number - 1031

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Houston, Texas, United States, 77030

Site Number - 1028

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Houston, Texas, United States, 77054

Site Number -1023

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Irving, Texas, United States, 75031

Site Number - 1021

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Irving, Texas, United States, 75039

Site Number - 1025

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McKinney, Texas, United States, 75069

Site Number - 1011

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San Antonio, Texas, United States, 78231

Site Number - 1016

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Norfolk, Virginia, United States, 23510

More Information

Sponsor

Immunovant Sciences GmbH

Last update posted

Aug 25, 2026

Last verified

Aug, 2026

Keywords

IMVT-1402
Graves' disease
Thyroid-Stimulating Hormone Receptor
Immunoglobulin G
Antithyroid drug
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.