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NCT07661056PHASE3Recruiting

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

Biohaven Therapeutics Ltd.

Start Date

6/26/2026

Completion Date

2/1/2028

Summary

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

Age Range: 18 years to 70 years

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.

Interventions

DRUG

BHV-1300

DRUG

Placebo

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Conditions

Graves Disease

Locations

Site-032

Burbank, California 91501

United States

Site-062

Huntington Beach, California 92647

United States

Site-006

San Diego, California 92108

United States

Site-067

Walnut Creek, California 94598

United States

Site-052

Doral, Florida 33172

United States

Site-019

Hialeah, Florida 33016

United States

Site-031

Champaign, Illinois 61822

United States

Site-025

Lenexa, Kansas 66234

United States

Site-072

Las Vegas, Nevada 89148

United States

Site-038

Asheville, North Carolina 28803

United States

Site-011

Greenville, North Carolina 27834

United States

Site-064

Morehead City, North Carolina 28557

United States

Site-039

Raleigh, North Carolina 27612

United States

Site-033

Statesville, North Carolina 28625

United States

Site-045

Wilmington, North Carolina 28405

United States

Site-008

Canton, Ohio 44718

United States

Site-055

Dallas, Texas 75231

United States

Site-043

Denton, Texas 76210

United States

Site-042

El Paso, Texas 79935

United States

Site-071

Houston, Texas 77058

United States

Site-054

McKinney, Texas 75069

United States

Site-013

Layton, Utah 84041

United States

Site-073

Midlothian, Virginia 23112

United States

Site-076

Seattle, Washington 98104

United States