BHV-1300 for adults with Graves’ disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 interventional trial evaluates the efficacy and safety of BHV-1300 in adults with active hyperthyroidism due to Graves’ disease. Participants are randomly assigned to receive BHV-1300 or placebo, with outcomes assessed for thyroid function and safety. Eligible participants have serologically confirmed Graves’ disease and active hyperthyroidism, while certain thyroid conditions or prior thyroid treatments exclude enrollment. The study is conducted at three U.S. sites and is sponsored by Biohaven Therapeutics Ltd.

Why it matters

Who can join: the full rules

Key Inclusion Criteria:

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

Key Exclusion Criteria:

1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
2. History of treatment with radioactive iodine or thyroid surgery.
3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit.
4. 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.
5. Have autoimmune disease other than Graves' disease requiring treatment
6. 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.
7. Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.

Where it's running

• Site-044
  Tucson, Arizona, United States Recruiting
• Site-032
  Burbank, California, United States Recruiting
• Site-062
  Huntington Beach, California, United States Recruiting
• Site-048
  Oakland, California, United States Recruiting
• Site-006
  San Diego, California, United States Recruiting
• Site-078
  South Gate, California, United States Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Chief Medical Officer
• Email: clinicaltrials@biohavenpharma.com
• Phone: 203-404-0410

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• YB-101 for Graves' Disease: safety, dosing, and how it works

  This study tests YB-101 versus placebo in adults with Graves' disease to see if it is safe, tolerated, and whether it can help thyroid symptoms over about 40 weeks.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.