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Clinical Trials in Poland / 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 Poland 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Site Number - 1032 Phoenix Arizona Withdrawn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 Poland

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 Safety, Tolerability, and Efficacy of IMVT-1402 in Participants With Cutaneous Lupus Erythematosus (CLE) Active, not recruiting
A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease Recruiting
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

A Long-Term Extension Study of IMVT-1402 in Adult Participants With Graves' Disease (GD) Enrolling by invitation
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease 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 Poland