Recruiting

Phase 3

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

Sponsor:

Biohaven Therapeutics Ltd.

Code:

NCT07661056

Conditions

Graves Disease

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

Interventions

BHV-1300

Placebo

Study Details

Brief 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

Conditions

Graves Disease

Study ID

NCT07661056

Start date

Jun 26, 2026

Status verified date

Sep, 2026

Completion date

Feb, 2028

Anticipated

Primary completion date

Jan, 2028

Anticipated

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

300 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BHV-1300

BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.

placebo comparator: Placebo

Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.

Interventions

BHV-1300

delivered subcutaneously via autoinjector

Placebo

delivered subcutaneously via autoinjector

Primary outcome measure

Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26. [ Time Frame: Week 26 ]

Central Contacts and Locations

Central contacts

Chief Medical Officer

203-404-0410 clinicaltrials@biohavenpharma.com

Locations

Site-044

Recruiting

Tucson, Arizona, United States, 85741

Site-032

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Burbank, California, United States, 91501

Site-062

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Huntington Beach, California, United States, 92647

Site-048

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Oakland, California, United States, 94611

Site-006

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San Diego, California, United States, 92108

Site-067

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Walnut Creek, California, United States, 94598

Site-052

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Doral, Florida, United States, 33172

Site-066

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Fort Myers, Florida, United States, 33919

Site-019

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Hialeah, Florida, United States, 33016

Site-061

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Miami, Florida, United States, 33010

Site-059

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Palm Beach Gardens, Florida, United States, 33410

Site-074

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Tampa, Florida, United States, 33634

Site-029

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Atlanta, Georgia, United States, 30303

Site-053

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Fayetteville, Georgia, United States, 30214

Site-031

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Champaign, Illinois, United States, 61822

Site-080

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Springfield, Illinois, United States, 62702

Site-025

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Lenexa, Kansas, United States, 66234

Site-046

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Farmington Hills, Michigan, United States, 48334

Site-072

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Las Vegas, Nevada, United States, 89148

Site-038

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Asheville, North Carolina, United States, 28803

Site-011

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Greenville, North Carolina, United States, 27834

Site-063

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Morehead City, North Carolina, United States, 28557

Site-064

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Morehead City, North Carolina, United States, 28557

Site-039

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Raleigh, North Carolina, United States, 27612

Site-033

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Statesville, North Carolina, United States, 28625

Site-045

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Wilmington, North Carolina, United States, 28405

Site-008

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Canton, Ohio, United States, 44718

Site-037

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Norman, Oklahoma, United States, 73072

Site-016

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Chattanooga, Tennessee, United States, 37411

Site-017

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Memphis, Tennessee, United States, 38119

Site-081

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Amarillo, Texas, United States, 79124

Site-055

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Dallas, Texas, United States, 75231

Site-020

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Dallas, Texas, United States, 75246

Site-043

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Denton, Texas, United States, 76210

Site-042

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El Paso, Texas, United States, 79935

Site-034

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Houston, Texas, United States, 77040

Site-071

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Houston, Texas, United States, 77058

Site-054

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McKinney, Texas, United States, 75069

Site-057

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San Antonio, Texas, United States, 78251

Site-036

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Shavano Park, Texas, United States, 78231

Site-009

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Weslaco, Texas, United States, 78596

Site-013

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Layton, Utah, United States, 84041

Site-073

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Midlothian, Virginia, United States, 23112

Site-076

Recruiting

Seattle, Washington, United States, 98104

More Information

Sponsor

Biohaven Therapeutics Ltd.

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

Hyperthyroidism

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biohaven Therapeutics Ltd. on 2026-09-03.