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

• IMVT-1402 (Drug): Dose 1 for 26 weeks
• IMVT-1402 (Drug): Dose 2 for 26 weeks
• Placebo (Drug): For 26 weeks

Primary outcomes

• Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 1) [Week 26]

Secondary outcomes

• 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) [Week 26]
• Percentage of participants who are euthyroid, off ATD, and seronegative at Week 26 (Dose 1) [Week 26]
• Percentage of participants who are euthyroid and off ATD at Week 26 (Dose 2) [Week 26]
• Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN and are off ATD at Week 26 (Dose 2) [Week 26]
• Percentage of participants who are euthyroid, off ATD, and seronegative (Dose 2) [Week 26]
• Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1) [Baseline, Week 4]
• Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 1) [Baseline, Week 2]
• Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 4 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2) [Baseline, Week 4]
• Percentage of participants who have T3 (Total T3 or FT3) and FT4 ≤ ULN at Week 2 in participants who have T3 (Total T3 or FT3) and/or FT4 > ULN at baseline (Dose 2) [Baseline, Week 2]

Sex: All, ages: 18 Years to 75 Years

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.

63 more sites not listed.

NIH grants: 2025