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

NCT ID: NCT07018323

Last Updated: 2026-01-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

210 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-06-19

Study Completion Date

2027-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Graves' Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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IMVT-1402 Dose 1

Group Type EXPERIMENTAL

IMVT-1402

Intervention Type DRUG

Dose 1 for 26 weeks

IMVT-1402 Dose 2

Group Type EXPERIMENTAL

IMVT-1402

Intervention Type DRUG

Dose 2 for 26 weeks

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

For 26 weeks

Interventions

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IMVT-1402

Dose 1 for 26 weeks

Intervention Type DRUG

IMVT-1402

Dose 2 for 26 weeks

Intervention Type DRUG

Placebo

For 26 weeks

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunovant Sciences GmbH

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Site Number - 1015

Tucson, Arizona, United States

Site Status RECRUITING

Site Number -1014

Concord, California, United States

Site Status RECRUITING

Site Number - 1013

Aurora, Colorado, United States

Site Status RECRUITING

Site Number - 1024

Doral, Florida, United States

Site Status RECRUITING

Site Number - 1008

Hialeah, Florida, United States

Site Status RECRUITING

Site Number - 1000

Miami, Florida, United States

Site Status RECRUITING

Site Number - 1020

Columbus, Georgia, United States

Site Status RECRUITING

Site Number - 1022

Topeka, Kansas, United States

Site Status RECRUITING

Site Number - 1033

Jefferson City, Missouri, United States

Site Status RECRUITING

Site Number - 1004

Kansas City, Missouri, United States

Site Status RECRUITING

Site Number - 1019

St Louis, Missouri, United States

Site Status RECRUITING

Site Number - 1012

Reno, Nevada, United States

Site Status RECRUITING

Site Number - 1032

Long Island City, New York, United States

Site Status RECRUITING

Site Number - 1027

New Hyde Park, New York, United States

Site Status RECRUITING

Site Number - 1009

New York, New York, United States

Site Status RECRUITING

Site Number - 1018

Williamsville, New York, United States

Site Status RECRUITING

Site Number - 1010

Chapel Hill, North Carolina, United States

Site Status RECRUITING

Site Number - 1026

Hickory, North Carolina, United States

Site Status RECRUITING

Site Number - 1001

Morehead City, North Carolina, United States

Site Status RECRUITING

Site Number - 1034

Raleigh, North Carolina, United States

Site Status RECRUITING

Site Number - 1007

Oklahoma City, Oklahoma, United States

Site Status RECRUITING

Site Number - 1017

Memphis, Tennessee, United States

Site Status RECRUITING

Site Number - 1029

Dallas, Texas, United States

Site Status RECRUITING

Site Number - 1002

El Paso, Texas, United States

Site Status RECRUITING

Site Number - 1003

Fort Worth, Texas, United States

Site Status RECRUITING

Site Number - 1031

Houston, Texas, United States

Site Status RECRUITING

Site Number - 1028

Houston, Texas, United States

Site Status RECRUITING

Site Number -1023

Irving, Texas, United States

Site Status RECRUITING

Site Number - 1021

Irving, Texas, United States

Site Status RECRUITING

Site Number - 1025

McKinney, Texas, United States

Site Status RECRUITING

Site Number - 1011

San Antonio, Texas, United States

Site Status RECRUITING

Site Number - 1016

Norfolk, Virginia, United States

Site Status RECRUITING

Site Number - 5105

Sydney, New South Wales, Australia

Site Status RECRUITING

Site Number - 5103

Warrawong, New South Wales, Australia

Site Status RECRUITING

Site Number - 5101

Brisbane, Queensland, Australia

Site Status RECRUITING

Site Number - 5100

Southport, Queensland, Australia

Site Status RECRUITING

Site Number - 5104

Geelong, Victoria, Australia

Site Status RECRUITING

Site Number - 5108

Perth, , Australia

Site Status RECRUITING

Site Number - 5109

Saint Leonards, , Australia

Site Status RECRUITING

Site Number - 5613

Dobrich, , Bulgaria

Site Status RECRUITING

Site Number - 5606

Plovdiv, , Bulgaria

Site Status RECRUITING

Site Number - 5607

Plovdiv, , Bulgaria

Site Status RECRUITING

Site Number - 5601

Sliven, , Bulgaria

Site Status RECRUITING

Site Number - 5612

Smolyan, , Bulgaria

Site Status RECRUITING

Site Number - 5604

Sofia, , Bulgaria

Site Status RECRUITING

Site Number - 5609

Sofia, , Bulgaria

Site Status RECRUITING

Site Number - 5608

Sofia, , Bulgaria

Site Status RECRUITING

Site Number - 5602

Varna, , Bulgaria

Site Status RECRUITING

Site Number - 5603

Varna, , Bulgaria

Site Status RECRUITING

Site Number - 5611

Varna, , Bulgaria

Site Status RECRUITING

Site Number - 5600

Yambol, , Bulgaria

Site Status RECRUITING

Site Number - 3203

Náchod, , Czechia

Site Status RECRUITING

Site Number - 3201

Prague, , Czechia

Site Status RECRUITING

Site Number - 3200

Prague, , Czechia

Site Status RECRUITING

Site Number - 3202

Prague, , Czechia

Site Status RECRUITING

Site Number - 8004

Imereti, , Georgia

Site Status RECRUITING

Site Number - 8003

Tbilisi, , Georgia

Site Status RECRUITING

Site Number - 8000

Tbilisi, , Georgia

Site Status RECRUITING

Site Number - 8002

Tbilisi, , Georgia

Site Status RECRUITING

Site Number - 8001

Tbilisi, , Georgia

Site Status RECRUITING

Site Number - 8005

Tbilisi, , Georgia

Site Status RECRUITING

Site Number - 3902

Athens, , Greece

Site Status RECRUITING

Site Number - 3900

Athens, , Greece

Site Status RECRUITING

Site Number - 3901

Athens, , Greece

Site Status RECRUITING

Site Number - 4202

Ramat Gan, Central District, Israel

Site Status RECRUITING

Site Number - 4205

Haifa, Haifa District, Israel

Site Status RECRUITING

Site Number - 4203

Haifa, Haifa District, Israel

Site Status RECRUITING

Site Number - 4209

Nahariya, Northern District, Israel

Site Status RECRUITING

Site Number - 4206

Tzfat, Northern District, Israel

Site Status RECRUITING

Site Number - 4211

Beersheba, Southern District, Israel

Site Status RECRUITING

Site Number - 4201

Jerusalem, , Israel

Site Status RECRUITING

Site Number - 4204

Jerusalem, , Israel

Site Status RECRUITING

Site Number - 4200

Petah Tikva, , Israel

Site Status RECRUITING

Site Number - 4207

Tel Aviv, , Israel

Site Status RECRUITING

Site Number - 4600

Ogre, , Latvia

Site Status RECRUITING

Site Number - 4602

Riga, , Latvia

Site Status RECRUITING

Site Number - 4603

Riga, , Latvia

Site Status RECRUITING

Site Number - 4604

Sigulda, , Latvia

Site Status RECRUITING

Site Number - 4601

Ventspils, , Latvia

Site Status RECRUITING

Site Number - 3301

Auckland, , New Zealand

Site Status RECRUITING

Site Number - 3300

Wellington, , New Zealand

Site Status RECRUITING

Site Number - 3002

Bydgoszcz, , Poland

Site Status RECRUITING

Site Number - 3010

Chorzów, , Poland

Site Status RECRUITING

Site Number - 3007

Kielce, , Poland

Site Status RECRUITING

Site Number - 3000

Lublin, , Poland

Site Status RECRUITING

Site Number - 3005

Olsztyn, , Poland

Site Status RECRUITING

Site Number - 3009

Opole, , Poland

Site Status RECRUITING

Site Number - 3006

Poznan, , Poland

Site Status RECRUITING

Site Number - 3008

Warsaw, , Poland

Site Status RECRUITING

Site Number - 4500

Daegu, , South Korea

Site Status RECRUITING

Site Number - 4503

Goyang, , South Korea

Site Status RECRUITING

Site Number - 4504

Guri-si, , South Korea

Site Status RECRUITING

Site Number - 4501

Seoul, , South Korea

Site Status RECRUITING

Site Number - 4506

Seoul, , South Korea

Site Status RECRUITING

Site Number - 4505

Seoul, , South Korea

Site Status RECRUITING

Site Number - 7009

Cornwell, , United Kingdom

Site Status RECRUITING

Site Number - 7001

London, , United Kingdom

Site Status RECRUITING

Countries

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United States Australia Bulgaria Czechia Georgia Greece Israel Latvia New Zealand Poland South Korea United Kingdom

Central Contacts

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Central Study Contact

Role: CONTACT

18007970414

Other Identifiers

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2025-521920-31-00

Identifier Type: CTIS

Identifier Source: secondary_id

IMVT-1402-2503

Identifier Type: -

Identifier Source: org_study_id

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