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

NCT06727604 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: IMVT-1402-25022024-516020-33-00
• Study Type: interventional
• Target: 240
• Locations: 10 countries
• Sites: 130

Brief 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.

Conditions

Graves' Disease

Keywords

IMVT-1402; Anti Thyroid Drug; Hyperthyroidism; Autoimmune thyroid disease; Imeroprubart

Outcome Measures

Primary Outcomes (1)

• Percentage of participants who are euthyroid (local laboratory T3 [Total T3 or FT3], FT4, and TSH values within normal limits) and off ATD at Week 26

  Week 26

Secondary Outcomes (11)

• Percentage of participants who are euthyroid and off ATD at Week 52

  Week 52

• Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52

  Week 52

• Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78

  Week 78

• Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104

  Week 104

• Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52

  Week 52

Study Arms (4)

Group 1 Period 1 and 2: IMVT-1402

EXPERIMENTAL

Drug: IMVT-1402

Group 2 Period 1 and 2: IMVT-1402

EXPERIMENTAL

Drug: IMVT-1402

Group 2 Period 1: IMVT-1402 and Period 2: Placebo

EXPERIMENTAL

Drug: IMVT-1402

Group 3 Period 1 and 2: Placebo

PLACEBO COMPARATOR

Drug: Placebo

Interventions

Placebo DRUG

SC QW for 52 weeks

Group 3 Period 1 and 2: Placebo

IMVT-1402 DRUG

600 mg SC QW for 52 weeks

Group 1 Period 1 and 2: IMVT-1402; Group 2 Period 1 and 2: IMVT-1402

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 (130)

Site Number - 1032

Phoenix, Arizona, 85006, United States

RECRUITING

Site Number - 1036

Phoenix, Arizona, 85015, United States

RECRUITING

Site Number - 1061

Huntington Beach, California, 92647, United States

RECRUITING

Site Number - 1001

Los Angeles, California, 90033, United States

RECRUITING

Site Number - 1047

Los Angeles, California, 90095, United States

RECRUITING

Site Number - 1062

Orange, California, 92868, United States

RECRUITING

Site Number - 1046

Sacramento, California, 95816, United States

RECRUITING

Site Number - 1034

San Francisco, California, 94143, United States

RECRUITING

Site Number - 1035

Santa Clarita, California, 91321, United States

RECRUITING

Site Number - 1005

Torrance, California, 90502, United States

RECRUITING

Site Number - 1006

Walnut Creek, California, 94598, United States

WITHDRAWN

Site Number - 1013

Englewood, Colorado, 80113, United States

RECRUITING

Site Number - 1010

Newark, Delaware, 19713, United States

RECRUITING

Site Number - 1040

Washington D.C., District of Columbia, 20010, United States

RECRUITING

Site Number - 1029

Clearwater, Florida, 33756, United States

RECRUITING

Site Number - 1055

Jacksonville, Florida, 32204-1177, United States

RECRUITING

Site Number - 1056

Jacksonville, Florida, 32216, United States

RECRUITING

Site Number - 1028

Miami, Florida, 33136, United States

RECRUITING

Site Number - 1065

Miami, Florida, 33186, United States

RECRUITING

Site Number - 1064

Ocoee, Florida, 34761, United States

RECRUITING

Site Number - 1011

Orlando, Florida, 32819, United States

RECRUITING

Site Number - 1016

Port Charlotte, Florida, 33952, United States

RECRUITING

Site Number - 1012

West Palm Beach, Florida, 33401, United States

RECRUITING

Site Number - 1038

Atlanta, Georgia, 30318, United States

RECRUITING

Site Number - 1053

Macon, Georgia, 31210, United States

RECRUITING

Site Number - 1020

Stockbridge, Georgia, 30281, United States

RECRUITING

Site Number - 1027

Indianapolis, Indiana, 46202, United States

RECRUITING

Site Number - 1041

Kansas City, Kansas, 66210, United States

RECRUITING

Site Number - 1045

Bowling Green, Kentucky, 42101, United States

RECRUITING

Site Number - 1054

Florence, Kentucky, 41042, United States

RECRUITING

Site Number - 1022

New Orleans, Louisiana, 70112, United States

RECRUITING

Site Number - 1048

Shreveport, Louisiana, 71103, United States

RECRUITING

Site Number - 1023

Baltimore, Maryland, 21287, United States

RECRUITING

Site Number - 1026

Boston, Massachusetts, 02114, United States

RECRUITING

Site Number - 1018

Farmington Hills, Michigan, 48334, United States

RECRUITING

Site Number - 1069

Flint, Michigan, 48532, United States

RECRUITING

Site Number - 1008

Rochester, Minnesota, 55905, United States

RECRUITING

Site Number - 1068

Gulfport, Mississippi, 39501, United States

RECRUITING

Site Number - 1017

Omaha, Nebraska, 68105, United States

RECRUITING

Site Number - 1007

Las Vegas, Nevada, 89148, United States

RECRUITING

Site Number - 1050

Monroe, New York, 10950, United States

RECRUITING

Site Number - 1051

Asheville, North Carolina, 28803, United States

RECRUITING

Site Number - 1060

Wilmington, North Carolina, 28401, United States

RECRUITING

Site Number - 1057

Canton, Ohio, 44718, United States

RECRUITING

Site Number - 1003

Portland, Oregon, 97035, United States

RECRUITING

Site Number - 1033

Philadelphia, Pennsylvania, 19140, United States

RECRUITING

Site Number - 1043

Pottstown, Pennsylvania, 19464, United States

RECRUITING

Site Number - 1015

Summerville, South Carolina, 29485, United States

RECRUITING

Site Number - 1042

Chattanooga, Tennessee, 37421, United States

RECRUITING

Site Number - 1066

Nashville, Tennessee, 37203, United States

RECRUITING

Site Number - 1002

Austin, Texas, 78731, United States

RECRUITING

Site Number - 1067

Bellaire, Texas, 77401, United States

RECRUITING

Site Number - 1019

Dallas, Texas, 75208, United States

RECRUITING

Site Number - 1031

Dallas, Texas, 75231, United States

RECRUITING

Site Number - 1071

Houston, Texas, 77089, United States

RECRUITING

Site Number - 1025

Houston, Texas, 77095, United States

WITHDRAWN

Site Number - 1004

Mesquite, Texas, 75149, United States

RECRUITING

Site Number - 1009

Round Rock, Texas, 78681, United States

RECRUITING

Site Number - 1014

San Antonio, Texas, 78215, United States

RECRUITING

Site Number - 1052

San Antonio, Texas, 78240, United States

RECRUITING

Site Number - 1030

Salt Lake City, Utah, 84108, United States

RECRUITING

Site Number - 1070

Sandy City, Utah, 84093, United States

RECRUITING

Site Number - 5303

Antwerp, 2820, Belgium

RECRUITING

Site Number - 5301

Bruges, 80000, Belgium

RECRUITING

Site Number - 5302

Brussels, 1070, Belgium

RECRUITING

Site Number - 8002

Batumi, 6000, Georgia

RECRUITING

Site Number - 8007

Batumi, 6010, Georgia

RECRUITING

Site Number - 8006

Kutaisi, 4600, Georgia

RECRUITING

Site Number - 8008

Marneuli, 3000, Georgia

RECRUITING

Site Number - 8009

Tbilisi, 0112, Georgia

RECRUITING

Site Number - 8004

Tbilisi, 0144, Georgia

RECRUITING

Site Number - 8005

Tbilisi, 0144, Georgia

RECRUITING

Site Number - 8001

Tbilisi, 0159, Georgia

RECRUITING

Site Number - 8003

Tbilisi, 0159, Georgia

RECRUITING

Site Number - 8011

Tbilisi, 0159, Georgia

RECRUITING

Site Number - 8010

Tbilisi, 0177, Georgia

RECRUITING

Site Number - 6505

Dresden, Saxony, 01307, Germany

RECRUITING

Site Number - 6503

Munich, 80336, Germany

RECRUITING

Site Number - 6508

Munich, 81667, Germany

RECRUITING

Site Number - 6502

Schwerin, 19049, Germany

RECRUITING

Site Number - 6507

Würzburg, 97080, Germany

RECRUITING

Site Number - 7558

Békéscsaba, 5600, Hungary

RECRUITING

Site Number - 7554

Budapest, 1036, Hungary

RECRUITING

Site Number - 7556

Budapest, 1083, Hungary

RECRUITING

Site Number - 7557

Debrecen, 4032, Hungary

RECRUITING

Site Number - 7551

Pécs, 7623, Hungary

RECRUITING

Site Number - 7552

Szeged, 6725, Hungary

RECRUITING

Site Number - 6004

Bologna, 40138, Italy

RECRUITING

Site Number - 6012

Cagliari, 09124, Italy

RECRUITING

Site Number - 6011

Genova, 16132, Italy

RECRUITING

Site Number - 6002

Milan, 20122, Italy

RECRUITING

Site Number - 6009

Milan, 20162, Italy

RECRUITING

Site Number - 6007

Milan, 20149, Italy

RECRUITING

Site Number - 6010

Naples, 80131, Italy

RECRUITING

Site Number - 6003

Pisa, 56124, Italy

RECRUITING

Site Number - 6001

Pisa, 56126, Italy

RECRUITING

Site Number - 6005

Roma, 00189, Italy

RECRUITING

Site Number - 6013

Siena, 53100, Italy

RECRUITING

Site Number - 6008

Varese, 21100, Italy

RECRUITING

Site Number - 3006

Gliwice, 44-102, Poland

RECRUITING

Site Number - 3002

Krakow, 30-074, Poland

RECRUITING

Site Number -3003

Krakow, 30-688, Poland

RECRUITING

Site Number - 3005

Lublin, 20-400, Poland

RECRUITING

Site Number - 3004

Lublin, 91-495, Poland

RECRUITING

Site Number - 3007

Poznan, 60-354, Poland

RECRUITING

Site Number - 3001

Warsaw, 00-0189, Poland

RECRUITING

Site Number - 1058

San Juan, 00907, Puerto Rico

RECRUITING

Site Number - 1037

San Juan, 00921-3313, Puerto Rico

RECRUITING

Site Number - 7104

Badalona, Barcelona, 08916, Spain

RECRUITING

Site Number - 7109

Barcelona, 08035, Spain

RECRUITING

Site Number - 7103

Barcelona, 08036, Spain

RECRUITING

Site Number - 7102

Córdoba, 14004, Spain

RECRUITING

Site Number - 7106

Granada, 18014, Spain

RECRUITING

Site Number - 7105

Madrid, 28006, Spain

RECRUITING

Site Number - 7107

Pamplona, 31008, Spain

RECRUITING

Site Number - 7108

Pamplona, 31008, Spain

RECRUITING

Site Number - 7101

Seville, 41009, Spain

RECRUITING

Site Number - 7013

Birmingham, England, B15 2TT, United Kingdom

RECRUITING

Site Number - 7012

Bristol, England, BS10 5NB, United Kingdom

RECRUITING

Site Number - 7011

Coventry, England, CV2 2DX, United Kingdom

RECRUITING

Site Number - 7007

London, England, NW1 2PG, United Kingdom

RECRUITING

Site Number - 7002

Cardiff, CF14 4XW, United Kingdom

RECRUITING

Site Number - 7008

Edinburgh, EH16 4SA, United Kingdom

RECRUITING

Site Number - 7005

Huddersfield, HD3 3EA, United Kingdom

RECRUITING

Site Number - 7004

Hull, HU6 7RX, United Kingdom

RECRUITING

Site Number - 7003

London, SE5 9RS, United Kingdom

RECRUITING

Site Number - 7006

Manchester, M20 4BX, United Kingdom

RECRUITING

Site Number - 7001

Newcastle upon Tyne, NE1 4LP, United Kingdom

RECRUITING

Site Number - 7009

Norwich, NR4 7UY, United Kingdom

RECRUITING

Site Number - 7010

Nuneaton, CV10 7DJ, United Kingdom

RECRUITING

MeSH Terms

Conditions

Graves Disease; Hyperthyroidism

Condition Hierarchy (Ancestors)

Exophthalmos; Orbital Diseases; Eye Diseases; Goiter; Thyroid Diseases; Endocrine System Diseases; 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: December 9, 2024
• First Posted: December 11, 2024
• Study Start: December 17, 2024
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: April 22, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

HU (6); IT (12); PL (7); US (62); DE (5); ES (9); GE (11); BE (3); GB (13); PR (2)