A Phase 3 interventional study of BHV-1300 and Placebo in Graves Disease, sponsored by Biohaven Therapeutics Ltd.. Recruiting at 56 sites in 3 countries. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-10-19.
Sponsored by Biohaven Therapeutics Ltd. · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid
162 studies on the registry are indexed under Graves Disease; 53 are open to participants now.
This study's planned enrollment of 300 is above the median of 60 across 104 interventional studies indexed under Graves Disease.
Browse Graves Disease studies →Biohaven Therapeutics Ltd. is the lead sponsor of 20 studies on the registry; 9 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
Key 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.
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.
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.
BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Drug: BHV-1300
Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Drug: Placebo
delivered subcutaneously via autoinjector
delivered subcutaneously via autoinjector
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
Time frame: Week 26
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.
Time frame: Week 26
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6
Time frame: Baseline to Week 6
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26
Time frame: Baseline to Week 26
Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26
Time frame: Week 26
Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo
Time frame: Up to 26 weeks
Time to euthyroidism (defined as Total T3, FT4, and TSH within normal limits) and off ATD of participants on BHV-1300 vs placebo
Time frame: Up to 26 weeks
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6
Time frame: Baseline to Week 6
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26
Time frame: Baseline to Week 26
Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26
Time frame: Week 26
Number of participants who are euthyroid (defined as Total T3, FT4, and TSH within normal limits), off ATD and TRAb seronegative at Week 26
Time frame: Week 26
Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths
Time frame: Up to 26 weeks
Number of unique participants with Grade 3 to 4 lab abnormalities
Time frame: Up to 26 weeks
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: BHV-1300
Biohaven Therapeutics Ltd.