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

NCT06727604 · tracked via the Priya Life Science USA tracker

Sponsor

Immunovant Sciences GmbH

Phase

Phase 2

Started

2024-12-17

Last updated

2026-08-25

Condition(s) studied

Graves' Disease

Investigational drug(s) / intervention(s)

IMVT-1402 →IMVT-1402 →Placebo

IMVT-1402: 600 mg SC QW for 52 weeks

IMVT-1402: 600 mg SC QW for 26 weeks followed by Placebo SC QW for 26 weeks

Placebo: SC QW for 52 weeks

Study 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

Sex

ALL

Min age

18 Years

Max age

75 Years

Healthy volunteers

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.

Primary outcome measure(s)

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

Trial sites (134)

Facility	City	Region	Status
Site Number - 1032	Phoenix	Arizona	Withdrawn
Site Number - 1036	Phoenix	Arizona	Recruiting
Site Number - 1061	Huntington Beach	California	Recruiting
Site Number - 1001	Los Angeles	California	Recruiting
Site Number - 1047	Los Angeles	California	Recruiting
Site Number - 1062	Orange	California	Recruiting
Site Number - 1046	Sacramento	California	Recruiting
Site Number - 1034	San Francisco	California	Recruiting
Site Number - 1035	Santa Clarita	California	Withdrawn
Site Number - 1005	Torrance	California	Recruiting
Site Number - 1006	Walnut Creek	California	Withdrawn
Site Number - 1013	Englewood	Colorado	Recruiting
Site Number - 1010	Newark	Delaware	Recruiting
Site Number - 1040	Washington D.C.	District of Columbia	Recruiting
Site Number - 1029	Clearwater	Florida	Recruiting
Site Number - 1055	Jacksonville	Florida	Recruiting
Site Number - 1056	Jacksonville	Florida	Recruiting
Site Number - 1028	Miami	Florida	Recruiting
Site Number - 1065	Miami	Florida	Recruiting
Site Number - 1064	Ocoee	Florida	Recruiting
Site Number - 1011	Orlando	Florida	Withdrawn
Site Number - 1016	Port Charlotte	Florida	Recruiting
Site Number - 1012	West Palm Beach	Florida	Withdrawn
Site Number - 1038	Atlanta	Georgia	Recruiting
Site Number - 1053	Macon	Georgia	Recruiting
Site Number - 1020	Stockbridge	Georgia	Withdrawn
Site Number - 1027	Indianapolis	Indiana	Recruiting
Site Number - 1041	Kansas City	Kansas	Recruiting
Site Number - 1045	Bowling Green	Kentucky	Recruiting
Site Number - 1054	Florence	Kentucky	Recruiting
Site Number - 1063	Metairie	Louisiana	Recruiting
Site Number - 1022	New Orleans	Louisiana	Recruiting
Site Number - 1048	Shreveport	Louisiana	Recruiting
Site Number - 1023	Baltimore	Maryland	Recruiting
Site Number - 1026	Boston	Massachusetts	Recruiting
Site Number - 1018	Farmington Hills	Michigan	Recruiting
Site Number - 1069	Flint	Michigan	Recruiting
Site Number - 1008	Rochester	Minnesota	Recruiting
Site Number - 1068	Gulfport	Mississippi	Recruiting
Site Number - 1017	Omaha	Nebraska	Recruiting

+ 94 more sites — see the full list on the official registry below.

More Immunovant Sciences GmbH trials in the USA

Imeroprubart in Adult Participants With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) Recruiting

Study to Assess the Efficacy and Safety of IMVT-1402 in Participants With Mild to Severe Generalized Myasthenia Gravis Recruiting

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

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation

A Study to Evaluate the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Active, Difficult to Treat Rheumatoid Arthritis Active, not recruiting

Other trials for the same condition

Evaluation of YB-101 for Safety, Tolerability, Pharmacokinetics, and Efficacy in Graves' Disease Recruiting

A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Recruiting

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

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation

A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old Recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06727604 on ClinicalTrials.gov ↗ ← All trials in the USA