Status:
RECRUITING
A Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 as Treatment for Adult Participants With Graves' Disease
Lead Sponsor:
Immunovant Sciences GmbH
Conditions:
Graves' Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
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 primar...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT06727604
Start Date
December 17 2024
End Date
June 1 2028
Last Update
March 6 2026
Active Locations (121)
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1
Site Number - 1032
Phoenix, Arizona, United States, 85006
2
Site Number - 1036
Phoenix, Arizona, United States, 85015
3
Site Number - 1061
Huntington Beach, California, United States, 92647
4
Site Number - 1001
Los Angeles, California, United States, 90033