A Phase 2 interventional study of IMVT-1402 and IMVT-1402 in Graves' Disease, sponsored by Immunovant Sciences GmbH. Recruiting at 134 sites in 10 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-08-25.
Sponsored by Immunovant Sciences GmbH · Phase 2, Interventional, and Treatment
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.
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 240 is above the median of 60 across 104 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Immunovant Sciences GmbH is the lead sponsor of 19 studies on the registry; 5 are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 5 (45%) have results posted.
Counted across the registry records on this site, refreshed daily.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: IMVT-1402
Drug: IMVT-1402
Drug: IMVT-1402
Drug: Placebo
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
Time frame: Week 26
Percentage of participants who are euthyroid and off ATD at Week 52
Time frame: Week 52
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 52
Time frame: Week 52
Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 52 to Week 78
Time frame: Week 78
Percentage of participants who are euthyroid and off ATD at Week 52 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 52 to Week 104
Time frame: Week 104
Percentage of participants who have a TRAb value a specified amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 6 months from Week 26 to Week 52
Time frame: Week 52
Percentage of participants who have a TRAb value a specific amount and are euthyroid and off ATD at Week 26 and remain euthyroid, off IMVT-1402, and off ATD for 12 months from Week 26 to Week 78
Time frame: Week 78
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
Time frame: 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
Time frame: Week 4
Percentage of participants who are euthyroid, off ATD, and seronegative for TRAb at Week 26
Time frame: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 26
Time frame: Week 26
Percentage of participants who have T3 (Total T3 or FT3) and FT4 < ULN and are off ATD at Week 52
Time frame: Week 52
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Started Dec 2024 (actual). Primary completion is estimated for Jun 2028, 42 months after the start.
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Studies of the drug tested here: Imeroprubart
Immunovant Sciences GmbH