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Clinical Trials in Belgium / NCT06727604
Recruiting Phase 2

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 Belgium 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
No
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)

FacilityCityRegionStatus
Site Number - 1032 Phoenix Arizona Withdrawn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 Belgium

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