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NCT06727604PHASE2Recruiting

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

12/17/2024

Completion Date

6/1/2028

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.

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 - 1032

Phoenix, Arizona 85006

United States

Site Number - 1036

Phoenix, Arizona 85015

United States

Site Number - 1061

Huntington Beach, California 92647

United States

Site Number - 1001

Los Angeles, California 90033

United States

Site Number - 1047

Los Angeles, California 90095

United States

Site Number - 1062

Orange, California 92868

United States

Site Number - 1046

Sacramento, California 95816

United States

Site Number - 1034

San Francisco, California 94143

United States

Site Number - 1035

Santa Clarita, California 91321

United States

Site Number - 1005

Torrance, California 90502

United States

Site Number - 1006

Walnut Creek, California 94598

United States

Site Number - 1013

Englewood, Colorado 80113

United States

Site Number - 1010

Newark, Delaware 19713

United States

Site Number - 1040

Washington D.C., District of Columbia 20010

United States

Site Number - 1029

Clearwater, Florida 33756

United States

Site Number - 1055

Jacksonville, Florida 32204-1177

United States

Site Number - 1056

Jacksonville, Florida 32216

United States

Site Number - 1028

Miami, Florida 33136

United States

Site Number - 1065

Miami, Florida 33186

United States

Site Number - 1064

Ocoee, Florida 34761

United States

Site Number - 1011

Orlando, Florida 32819

United States

Site Number - 1016

Port Charlotte, Florida 33952

United States

Site Number - 1012

West Palm Beach, Florida 33401

United States

Site Number - 1038

Atlanta, Georgia 30318

United States

Site Number - 1053

Macon, Georgia 31210

United States

Site Number - 1020

Stockbridge, Georgia 30281

United States

Site Number - 1027

Indianapolis, Indiana 46202

United States

Site Number - 1041

Kansas City, Kansas 66210

United States

Site Number - 1045

Bowling Green, Kentucky 42101

United States

Site Number - 1054

Florence, Kentucky 41042

United States

Site Number - 1063

Metairie, Louisiana 70006

United States

Site Number - 1022

New Orleans, Louisiana 70112

United States

Site Number - 1048

Shreveport, Louisiana 71103

United States

Site Number - 1023

Baltimore, Maryland 21287

United States

Site Number - 1026

Boston, Massachusetts 02114

United States

Site Number - 1018

Farmington Hills, Michigan 48334

United States

Site Number - 1069

Flint, Michigan 48532

United States

Site Number - 1008

Rochester, Minnesota 55905

United States

Site Number - 1068

Gulfport, Mississippi 39501

United States

Site Number - 1017

Omaha, Nebraska 68105

United States

Site Number - 1007

Las Vegas, Nevada 89148

United States

Site Number - 1050

Monroe, New York 10950

United States

Site Number - 1051

Asheville, North Carolina 28803

United States

Site Number - 1060

Wilmington, North Carolina 28401

United States

Site Number - 1057

Canton, Ohio 44718

United States

Site Number - 1003

Portland, Oregon 97035

United States

Site Number - 1033

Philadelphia, Pennsylvania 19140

United States

Site Number - 1043

Pottstown, Pennsylvania 19464

United States

Site Number - 1015

Summerville, South Carolina 29485

United States

Site Number - 1042

Chattanooga, Tennessee 37421

United States

Site Number - 1066

Nashville, Tennessee 37203

United States

Site Number - 1049

Nashville, Tennessee 37212

United States

Site Number - 1002

Austin, Texas 78731

United States

Site Number - 1067

Bellaire, Texas 77401

United States

Site Number - 1019

Dallas, Texas 75208

United States

Site Number - 1031

Dallas, Texas 75231

United States

Site Number - 1071

Houston, Texas 77089

United States

Site Number - 1025

Houston, Texas 77095

United States

Site Number - 1004

Mesquite, Texas 75149

United States

Site Number - 1009

Round Rock, Texas 78681

United States

Site Number - 1014

San Antonio, Texas 78215

United States

Site Number - 1052

San Antonio, Texas 78240

United States

Site Number - 1030

Salt Lake City, Utah 84108

United States

Site Number - 1070

Sandy City, Utah 84093

United States

Site Number - 5303

Antwerp, 2820

Belgium

Site Number - 5301

Bruges, 80000

Belgium

Site Number - 5302

Brussels, 1070

Belgium

Site Number - 8002

Batumi, 6000

Georgia

Site Number - 8007

Batumi, 6010

Georgia

Site Number - 8006

Kutaisi, 4600

Georgia

Site Number - 8008

Marneuli, 3000

Georgia

Site Number - 8009

Tbilisi, 0112

Georgia

Site Number - 8004

Tbilisi, 0144

Georgia

Site Number - 8005

Tbilisi, 0144

Georgia

Site Number - 8001

Tbilisi, 0159

Georgia

Site Number - 8003

Tbilisi, 0159

Georgia

Site Number - 8011

Tbilisi, 0159

Georgia

Site Number - 8010

Tbilisi, 0177

Georgia

Site Number - 6505

Dresden, Saxony 01307

Germany

Site Number - 6503

Munich, 80336

Germany

Site Number - 6508

Munich, 81667

Germany

Site Number - 6502

Schwerin, 19049

Germany

Site Number - 6507

Würzburg, 97080

Germany

Site Number - 7558

Békéscsaba, 5600

Hungary

Site Number - 7554

Budapest, 1036

Hungary

Site Number - 7556

Budapest, 1083

Hungary

Site Number - 7557

Debrecen, 4032

Hungary

Site Number - 7551

Pécs, 7623

Hungary

Site Number - 7552

Szeged, 6725

Hungary

Site Number - 6004

Bologna, 40138

Italy

Site Number - 6012

Cagliari, 09124

Italy

Site Number - 6011

Genova, 16132

Italy

Site Number - 6002

Milan, 20122

Italy

Site Number - 6009

Milan, 20162

Italy

Site Number - 6007

Milan, 20149

Italy

Site Number - 6010

Naples, 80131

Italy

Site Number - 6003

Pisa, 56124

Italy

Site Number - 6001

Pisa, 56126

Italy

Site Number - 6005

Roma, 00189

Italy

Site Number - 6013

Siena, 53100

Italy

Site Number - 6008

Varese, 21100

Italy

Site Number - 3006

Gliwice, 44-102

Poland

Site Number - 3002

Krakow, 30-074

Poland

Site Number -3003

Krakow, 30-688

Poland

Site Number - 3005

Lublin, 20-400

Poland

Site Number - 3008

Lublin, 20-607

Poland

Site Number - 3004

Lublin, 91-495

Poland

Site Number - 3007

Poznan, 60-354

Poland

Site Number - 3001

Warsaw, 00-0189

Poland

Site Number - 1058

San Juan, 00907

Puerto Rico

Site Number - 1037

San Juan, 00921-3313

Puerto Rico

Site Number - 7104

Badalona, Barcelona 08916

Spain

Site Number - 7109

Barcelona, 08035

Spain

Site Number - 7103

Barcelona, 08036

Spain

Site Number - 7102

Córdoba, 14004

Spain

Site Number - 7106

Granada, 18014

Spain

Site Number - 7105

Madrid, 28006

Spain

Site Number - 7107

Pamplona, 31008

Spain

Site Number - 7108

Pamplona, 31008

Spain

Site Number - 7101

Seville, 41009

Spain

Site Number - 7013

Birmingham, England B15 2TT

United Kingdom

Site Number - 7012

Bristol, England BS10 5NB

United Kingdom

Site Number - 7011

Coventry, England CV2 2DX

United Kingdom

Site Number - 7007

London, England NW1 2PG

United Kingdom

Site Number - 7014

Cambridge, London CB2 0QQ

United Kingdom

Site Number - 7002

Cardiff, CF14 4XW

United Kingdom

Site Number - 7008

Edinburgh, EH16 4SA

United Kingdom

Site Number - 7005

Huddersfield, HD3 3EA

United Kingdom

Site Number - 7004

Hull, HU6 7RX

United Kingdom

Site Number - 7003

London, SE5 9RS

United Kingdom

Site Number - 7006

Manchester, M20 4BX

United Kingdom

Site Number - 7001

Newcastle upon Tyne, NE1 4LP

United Kingdom

Site Number - 7009

Norwich, NR4 7UY

United Kingdom

Site Number - 7010

Nuneaton, CV10 7DJ

United Kingdom