Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease
Key facts
- Where
- East York, Surrey, and Winnipeg, CanadaSee the 4 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 70 years old?
Source: NCT07661056, who can take part
Where in Canada
- East York, OntarioHospital not named in the registryContact: Chief Medical OfficerTaking people
- East York, OntarioHospital not named in the registryContact: Chief Medical OfficerTaking people
- Surrey, British ColumbiaHospital not named in the registryContact: Chief Medical OfficerTaking people
- WinnipegHospital not named in the registryContact: Chief Medical OfficerTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Biohaven Therapeutics Ltd.
- Trial code
- NCT07661056EU 2026-526455-53-00
- Record updated
- 12 November 2026
- Original description
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroidRead full original descriptionShow less
A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
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
Inclusion: Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies; Participants must have active hyperthyroidism due to Graves' disease.
Exclusion: History of treatment with radioactive iodine or thyroid surgery; Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit; Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study; History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter); Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening; Have autoimmune disease other than Graves' disease requiring treatment; Have moderate to severe thyroid eye disease (TED) or are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.