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RecruitingPhase 3

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

Biohaven Therapeutics Ltd. · NCT07661056

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 18–70 · All sexes
Healthy volunteers
Not accepted (a condition is required)
Study type
Interventional · Phase 3
Target enrollment
300
US sites recruiting
53
Study start
June 26, 2026
Record last updated
October 19, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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

Being studied: BHV-1300; Placebo

Conditions: Graves Disease

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Key Inclusion Criteria

  • Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
  • Participants must have active hyperthyroidism due to Graves' disease

Key Exclusion Criteria

  • 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.
  • 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.
  • Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.

Recruiting US locations

Study contacts (from the official record)

  • Chief Medical Officer · 203-404-0410 · clinicaltrials@biohavenpharma.com
Study to Determine if BHV-1300 is Effective and Safe in Adults… (NCT07661056) | Bored Studies