Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBiohaven Therapeutics Ltd.

About this trial

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

Eligibility criteria

Qualifiers

Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies

Participants must have active hyperthyroidism due to Graves' disease

Disqualifiers

History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)

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.

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.

Trial design

Treatments tested in this trial

  • BHV-1300
  • Placebo

Treatment groups

300 Participants
are divided into 2 treatment groups

Sponsors and collaborators