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NCT07018323PHASE2Recruiting

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

Immunovant Sciences GmbH

Start Date

6/19/2025

Completion Date

5/1/2027

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.

Eligibility Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

IMVT-1402

DRUG

IMVT-1402

DRUG

Placebo

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Conditions

Graves' Disease

Locations

Site Number - 1015

Tucson, Arizona 85710

United States

Site Number -1014

Concord, California 94520

United States

Site Number - 1013

Aurora, Colorado 80045

United States

Site Number - 1024

Doral, Florida 33166

United States

Site Number - 1008

Hialeah, Florida 33016

United States

Site Number - 1000

Miami, Florida 33143

United States

Site Number - 1020

Columbus, Georgia 31904

United States

Site Number - 1022

Topeka, Kansas 66606

United States

Site Number - 1030

Louisville, Kentucky 40202

United States

Site Number - 1033

Jefferson City, Missouri 65109

United States

Site Number - 1004

Kansas City, Missouri 64110

United States

Site Number - 1019

St Louis, Missouri 63110

United States

Site Number - 1012

Reno, Nevada 89511

United States

Site Number - 1032

Long Island City, New York 11106

United States

Site Number - 1027

New Hyde Park, New York 11434

United States

Site Number - 1009

New York, New York 10022

United States

Site Number - 1018

Williamsville, New York 14221

United States

Site Number - 1010

Chapel Hill, North Carolina 27514

United States

Site Number - 1026

Hickory, North Carolina 28601

United States

Site Number - 1001

Morehead City, North Carolina 27577

United States

Site Number - 1034

Raleigh, North Carolina 27612

United States

Site Number - 1007

Oklahoma City, Oklahoma 73134

United States

Site Number - 1017

Memphis, Tennessee 38119

United States

Site Number - 1029

Dallas, Texas 75224

United States

Site Number - 1002

El Paso, Texas 79935

United States

Site Number - 1003

Fort Worth, Texas 76132

United States

Site Number - 1031

Houston, Texas 77030

United States

Site Number - 1028

Houston, Texas 77054

United States

Site Number -1023

Irving, Texas 75031

United States

Site Number - 1021

Irving, Texas 75039

United States

Site Number - 1025

McKinney, Texas 75069

United States

Site Number - 1011

San Antonio, Texas 78231

United States

Site Number - 1016

Norfolk, Virginia 23510

United States

Site Number - 5105

Sydney, New South Wales 2050

Australia

Site Number - 5103

Warrawong, New South Wales 2502

Australia

Site Number - 5101

Brisbane, Queensland 4101

Australia

Site Number - 5107

Douglas, Queensland 4814

Australia

Site Number - 5100

Southport, Queensland 4222

Australia

Site Number - 5102

Box Hill, Victoria 3128

Australia

Site Number - 5104

Geelong, Victoria 3220

Australia

Site Number - 5110

Parkville, Victoria 3050

Australia

Site Number - 5108

Perth, 6009

Australia

Site Number - 5109

Saint Leonards, 2065

Australia

Site Number - 5511

Fortaleza, Ceará 21941-913

Brazil

Site Number - 5513

Belo Horizonte, Minas Gerais 30150-320

Brazil

Site Number - 5500

Campinas, São Paulo 09060-870

Brazil

Site Number - 5505

Santo André, São Paulo 09060-870

Brazil

Site Number - 5502

Brasília, 70200-730

Brazil

Site Number - 5503

Curitiba, 80060-240

Brazil

Site Number - 5504

Curitiba, 80810040

Brazil

Site Number - 5501

Porto Alegre, 90035903

Brazil

Site Number - 5512

Rio de Janeiro, 21941-913

Brazil

Site Number - 5506

São Paulo, 01221-020

Brazil

Site Number - 5508

São Paulo, 01228-000

Brazil

Site Number - 5510

São Paulo, 05403-000

Brazil

Site Number - 5507

São Paulo, 15500-003

Brazil

Site Number - 5509

São Paulo, 17504-072

Brazil

Site Number - 5610

Sofia, Sofia-Grad 1431

Bulgaria

Site Number - 5613

Dobrich, 7002

Bulgaria

Site Number - 5606

Plovdiv, 4001

Bulgaria

Site Number - 5607

Plovdiv, 4002

Bulgaria

Site Number - 5601

Sliven, 8800

Bulgaria

Site Number - 5612

Smolyan, 4700

Bulgaria

Site Number - 5604

Sofia, 1233

Bulgaria

Site Number - 5609

Sofia, 1431

Bulgaria

Site Number - 5608

Sofia, 1680

Bulgaria

Site Number- 5605

Sofia, 1750

Bulgaria

Site Number - 5602

Varna, 9002

Bulgaria

Site Number - 5603

Varna, 9020

Bulgaria

Site Number - 5611

Varna, 9020

Bulgaria

Site Number - 5600

Yambol, 8600

Bulgaria

Site Number - 5700

Santiago, 7690000

Chile

Site Number - 5701

Santiago, 8380456

Chile

Site Number - 3203

Náchod, 547 01

Czechia

Site Number - 3201

Prague, 149 00

Czechia

Site Number - 3200

Prague, 181 00

Czechia

Site Number - 3202

Prague, 190 14

Czechia

Site Number - 8004

Imereti, 4600

Georgia

Site Number - 8003

Tbilisi, 0114

Georgia

Site Number - 8000

Tbilisi, 0145

Georgia

Site Number - 8002

Tbilisi, 0159

Georgia

Site Number - 8001

Tbilisi, 0160

Georgia

Site Number - 8005

Tbilisi, 0186

Georgia

Site Number - 3902

Athens, 106 76

Greece

Site Number - 3900

Athens, 115 27

Greece

Site Number - 3901

Athens, 115 28

Greece

Site Number - 4202

Ramat Gan, Central District 5265601

Israel

Site Number - 4205

Haifa, Haifa District 3104802

Israel

Site Number - 4203

Haifa, Haifa District 3109601

Israel

Site Number - 4209

Nahariya, Northern District 2210001

Israel

Site Number - 4206

Tzfat, Northern District 1311001

Israel

Site Number - 4211

Beersheba, Southern District 8410101

Israel

Site Number - 4201

Jerusalem, 9103102

Israel

Site Number - 4204

Jerusalem, 9112001

Israel

Site Number - 4210

Kfar Saba, 4428164

Israel

Site Number - 4200

Petah Tikva, 4941492

Israel

Site Number - 4208

Rehovot, 7661041

Israel

Site Number - 4207

Tel Aviv, 6423906

Israel

Site Number - 6005

Rozzano, Milan 20089

Italy

Site Number - 6013

Acquaviva delle Fonti, 70021

Italy

Site Number - 6004

Bergamo, 24127

Italy

Site Number - 6015

Cuneo, 12100

Italy

Site Number - 6011

Livorno, 57124

Italy

Site Number - 6003

Milan, 20132

Italy

Site Number - 6014

Naples, 80131

Italy

Site Number - 6006

Pavia, 27100

Italy

Site Number - 6001

Rome, 135

Italy

Site Number - 6002

Udine, 33100

Italy

Site Number - 4010

Nagoya, Aichi-ken 467-8602

Japan

Site Number - 4001

Kamogawa, Chiba 296-0041

Japan

Site Number - 4011

Kitakyushu, Fukuoka 807-8555

Japan

Site Number - 4004

Kurume, Fukuoka 830-0011

Japan

Site Number - 4005

Minokamo, Gifu 505-8510

Japan

Site Number - 4008

Maebashi, Gunma 371-8512

Japan

Site Number - 4009

Yokohama, Kanagawa 230-8765

Japan

Site Number - 4003

Nankoku, Kochi 791-0295

Japan

Site Number - 4012

Shibuya City, Tokyo 150-8308

Japan

Site Number - 4007

Kumamoto, 860-8556

Japan

Site Number - 4006

Kyoto, 612-8555

Japan

Site Number - 4002

Nagasaki, 852-8501

Japan

Site Number - 4600

Ogre, LV-5001

Latvia

Site Number - 4605

Riga, LV-1002

Latvia

Site Number - 4602

Riga, LV-1006

Latvia

Site Number - 4603

Riga, LV-1050

Latvia

Site Number - 4604

Sigulda, LV-2150

Latvia

Site Number - 4601

Ventspils, LV-3601

Latvia

Site Number - 2003

Rotterdam, South Holland 3045 PM

Netherlands

Site Number - 2200

Rotterdam, South Holland 3079 DZ

Netherlands

Site Number - 2201

Rotterdam, South Holland 3083 AN

Netherlands

Site Number - 2202

Zwijndrecht, South Holland 3318 AT

Netherlands

Site Number - 3301

Auckland, 2025

New Zealand

Site Number - 3300

Wellington, 6242

New Zealand

Site Number - 3004

Bialystok, Podlaskie Voivodeship 15-276

Poland

Site Number - 3001

Szczecin, West Pomeranian Voivodeship 71-252

Poland

Site Number - 3002

Bydgoszcz, 85-605

Poland

Site Number - 3010

Chorzów, 41-516

Poland

Site Number - 3007

Kielce, 25-734

Poland

Site Number - 3000

Lublin, 20-607

Poland

Site Number - 3005

Olsztyn, 10-117

Poland

Site Number - 3009

Opole, 45-301

Poland

Site Number - 3006

Poznan, 60-693

Poland

Site Number - 3008

Warsaw, 02-482

Poland

Site Number - 3011

Warsaw, 02-507

Poland

Site Nnumber - 3003

Wroclaw, 50-367

Poland

Site Number - 4500

Daegu, 42415

South Korea

Site Number - 4503

Goyang, 410-77

South Korea

Site Number - 4504

Guri-si, 11923

South Korea

Site Number - 4501

Seoul, 02841

South Korea

Site Number - 4508

Seoul, 03080

South Korea

Site Number - 4506

Seoul, 03181

South Korea

Site Number - 4505

Seoul, 05278

South Korea

Site Number - 4507

Seoul, 6591

South Korea

Site Number - 7009

Cornwell, TR1 3LJ

United Kingdom

Site Number - 7006

London, SE1 9RT

United Kingdom

Site Number - 7001

London, W2 1NY

United Kingdom

Site Number - 7003

Merthyr Tydfil, CF72 8XR

United Kingdom

Site Number - 7010

Salford, M6 8HD

United Kingdom

Site Number - 7008

Surrey, GU2 7XX

United Kingdom