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

NCT07018323 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMVT-1402-25032025-521920-31-00
• Study Type: interventional
• Target: 210
• Locations: 15 countries
• Sites: 120

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)

  Week 26

Secondary Outcomes (9)

• Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)

  Week 26

• Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)

  Week 26

• Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)

  Week 26

• Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)

  Week 26

• Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2)

  Week 26

Study Arms (3)

IMVT-1402 Dose 1

EXPERIMENTAL

Drug: IMVT-1402

IMVT-1402 Dose 2

EXPERIMENTAL

Drug: IMVT-1402

Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

IMVT-1402 DRUG

Dose 1 for 26 weeks

IMVT-1402 Dose 1

Placebo DRUG

For 26 weeks

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Immunovant Sciences GmbH: lead

Study Sites (120)

Site Number - 1015

Tucson, Arizona, 85710, United States

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Site Number -1014

Concord, California, 94520, United States

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Site Number - 1013

Aurora, Colorado, 80045, United States

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Site Number - 1024

Doral, Florida, 33166, United States

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Site Number - 1008

Hialeah, Florida, 33016, United States

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Site Number - 1000

Miami, Florida, 33143, United States

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Site Number - 1020

Columbus, Georgia, 31904, United States

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Site Number - 1022

Topeka, Kansas, 66606, United States

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Site Number - 1030

Louisville, Kentucky, 40202, United States

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Site Number - 1033

Jefferson City, Missouri, 65109, United States

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Site Number - 1004

Kansas City, Missouri, 64110, United States

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Site Number - 1019

St Louis, Missouri, 63110, United States

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Site Number - 1012

Reno, Nevada, 89511, United States

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Site Number - 1032

Long Island City, New York, 11106, United States

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Site Number - 1027

New Hyde Park, New York, 11434, United States

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Site Number - 1009

New York, New York, 10022, United States

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Site Number - 1018

Williamsville, New York, 14221, United States

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Site Number - 1010

Chapel Hill, North Carolina, 27514, United States

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Site Number - 1026

Hickory, North Carolina, 28601, United States

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Site Number - 1001

Morehead City, North Carolina, 27577, United States

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Site Number - 1034

Raleigh, North Carolina, 27612, United States

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Site Number - 1007

Oklahoma City, Oklahoma, 73134, United States

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Site Number - 1017

Memphis, Tennessee, 38119, United States

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Site Number - 1029

Dallas, Texas, 75224, United States

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Site Number - 1002

El Paso, Texas, 79935, United States

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Site Number - 1003

Fort Worth, Texas, 76132, United States

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Site Number - 1031

Houston, Texas, 77030, United States

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Site Number - 1028

Houston, Texas, 77054, United States

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Site Number -1023

Irving, Texas, 75031, United States

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Site Number - 1021

Irving, Texas, 75039, United States

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Site Number - 1025

McKinney, Texas, 75069, United States

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Site Number - 1011

San Antonio, Texas, 78231, United States

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Site Number - 1016

Norfolk, Virginia, 23510, United States

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Site Number - 5105

Sydney, New South Wales, 2050, Australia

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Site Number - 5103

Warrawong, New South Wales, 2502, Australia

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Site Number - 5101

Brisbane, Queensland, 4101, Australia

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Site Number - 5107

Douglas, Queensland, 4814, Australia

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Site Number - 5100

Southport, Queensland, 4222, Australia

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Site Number - 5102

Box Hill, Victoria, 3128, Australia

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Site Number - 5104

Geelong, Victoria, 3220, Australia

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Site Number - 5108

Perth, 6009, Australia

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Site Number - 5109

Saint Leonards, 2065, Australia

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Site Number - 5505

Santo André, São Paulo, 09060-870, Brazil

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Site Number - 5610

Sofia, Sofia-Grad, 1431, Bulgaria

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Site Number - 5613

Dobrich, 7002, Bulgaria

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Site Number - 5606

Plovdiv, 4001, Bulgaria

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Site Number - 5607

Plovdiv, 4002, Bulgaria

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Site Number - 5601

Sliven, 8800, Bulgaria

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Site Number - 5612

Smolyan, 4700, Bulgaria

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Site Number - 5604

Sofia, 1233, Bulgaria

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Site Number - 5609

Sofia, 1431, Bulgaria

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Site Number - 5608

Sofia, 1680, Bulgaria

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Site Number- 5605

Sofia, 1750, Bulgaria

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Site Number - 5602

Varna, 9002, Bulgaria

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Site Number - 5603

Varna, 9020, Bulgaria

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Site Number - 5611

Varna, 9020, Bulgaria

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Site Number - 5600

Yambol, 8600, Bulgaria

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Site Number - 3203

Náchod, 547 01, Czechia

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Site Number - 3201

Prague, 149 00, Czechia

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Site Number - 3200

Prague, 181 00, Czechia

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Site Number - 3202

Prague, 190 14, Czechia

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Site Number - 8004

Imereti, 4600, Georgia

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Site Number - 8003

Tbilisi, 0114, Georgia

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Site Number - 8000

Tbilisi, 0145, Georgia

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Site Number - 8002

Tbilisi, 0159, Georgia

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Site Number - 8001

Tbilisi, 0160, Georgia

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Site Number - 8005

Tbilisi, 0186, Georgia

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Site Number - 3902

Athens, 106 76, Greece

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Site Number - 3900

Athens, 115 27, Greece

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Site Number - 3901

Athens, 115 28, Greece

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Site Number - 4202

Ramat Gan, Central District, 5265601, Israel

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Site Number - 4205

Haifa, Haifa District, 3104802, Israel

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Site Number - 4203

Haifa, Haifa District, 3109601, Israel

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Site Number - 4209

Nahariya, Northern District, 2210001, Israel

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Site Number - 4206

Tzfat, Northern District, 1311001, Israel

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Site Number - 4211

Beersheba, Southern District, 8410101, Israel

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Site Number - 4201

Jerusalem, 9103102, Israel

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Site Number - 4204

Jerusalem, 9112001, Israel

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Site Number - 4210

Kfar Saba, 4428164, Israel

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Site Number - 4200

Petah Tikva, 4941492, Israel

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Site Number - 4208

Rehovot, 7661041, Israel

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Site Number - 4207

Tel Aviv, 6423906, Israel

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Site Number - 6005

Rozzano, Milan, 20089, Italy

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Site Number - 6003

Milan, 20132, Italy

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Site Number - 6006

Pavia, 27100, Italy

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Site Number - 6001

Rome, 135, Italy

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Site Number - 6002

Udine, 33100, Italy

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Site Number - 4600

Ogre, LV-5001, Latvia

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Site Number - 4602

Riga, LV-1006, Latvia

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Site Number - 4603

Riga, LV-1050, Latvia

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Site Number - 4604

Sigulda, LV-2150, Latvia

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Site Number - 4601

Ventspils, LV-3601, Latvia

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Site Number - 2003

Rotterdam, South Holland, 3045 PM, Netherlands

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Site Number - 2200

Rotterdam, South Holland, 3079 DZ, Netherlands

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Site Number - 2201

Rotterdam, South Holland, 3083 AN, Netherlands

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Site Number - 2202

Zwijndrecht, South Holland, 3318 AT, Netherlands

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Site Number - 3301

Auckland, 2025, New Zealand

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Site Number - 3300

Wellington, 6242, New Zealand

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Site Number - 3004

Bialystok, Podlaskie Voivodeship, 15-276, Poland

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Site Number - 3001

Szczecin, West Pomeranian Voivodeship, 71-252, Poland

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Site Number - 3002

Bydgoszcz, 85-605, Poland

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Site Number - 3010

Chorzów, 41-516, Poland

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Site Number - 3007

Kielce, 25-734, Poland

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Site Number - 3000

Lublin, 20-607, Poland

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Site Number - 3005

Olsztyn, 10-117, Poland

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Site Number - 3009

Opole, 45-301, Poland

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Site Number - 3006

Poznan, 60-693, Poland

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Site Number - 3008

Warsaw, 02-482, Poland

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Site Nnumber - 3003

Wroclaw, 50-367, Poland

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Site Number - 4500

Daegu, 42415, South Korea

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Site Number - 4503

Goyang, 410-77, South Korea

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Site Number - 4504

Guri-si, 11923, South Korea

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Site Number - 4501

Seoul, 02841, South Korea

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Site Number - 4506

Seoul, 03181, South Korea

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Site Number - 4505

Seoul, 05278, South Korea

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Site Number - 7009

Cornwell, TR1 3LJ, United Kingdom

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Site Number - 7006

London, SE1 9RT, United Kingdom

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Site Number - 7001

London, W2 1NY, United Kingdom

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Site Number - 7010

Salford, M6 8HD, United Kingdom

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Site Number - 7008

Surrey, GU2 7XX, United Kingdom

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MeSH Terms

Conditions

Graves Disease

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; Hyperthyroidism; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Central Study Contact

CONTACT

18007970414; clinicaltrials@immunovant.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 14, 2025
• First Posted: June 12, 2025
• Study Start: June 19, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

GE (6); NZ (2); AU (9); GR (3); US (33); BU (14); LA (5); CZ (4); PL (11); KR (6); IL (12); IT (5); NL (4); GB (5); BR (1)