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

RecruitingPhase 3

Sponsor: Biohaven Therapeutics Ltd.

Conditions: Graves Disease

Interventions: BHV-1300, Placebo

Countries: United States

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 overview

Sex: ALL

Age: 18 Years to 70 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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) and 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.

Locations (30)

Burbank, California, United States
Huntington Beach, California, United States
San Diego, California, United States
Walnut Creek, California, United States
Doral, Florida, United States
Hialeah, Florida, United States
Champaign, Illinois, United States
Lenexa, Kansas, United States
Farmington Hills, Michigan, United States
Las Vegas, Nevada, United States
Asheville, North Carolina, United States
Greenville, North Carolina, United States
Morehead City, North Carolina, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Statesville, North Carolina, United States
Wilmington, North Carolina, United States
Canton, Ohio, United States
Chattanooga, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Denton, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
McKinney, Texas, United States
San Antonio, Texas, United States
Shavano Park, Texas, United States
Layton, Utah, United States
Midlothian, Virginia, United States
Seattle, Washington, United States