This is a multi-center, global, randomized, double-blind, placebo-controlled Phase 2b 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.
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.
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.
Parallel
IMVT-1402
DrugDose 1 for 26 weeks
IMVT-1402
DrugDose 2 for 26 weeks
Placebo
DrugFor 26 weeks
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1)
Percentage of participants who have triiodothyronine (T3) (Total of T3 or free triiodothyronine [FT3]) and free thyroxine (FT4) ≤ upper limit of normal (ULN) and are off ATD at Week 26 (Dose 1)
Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1)
Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2)
Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2)
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