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

RecruitingPhase 3

A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease

Who can join

Ages 18 to 70 · All sexes

Full 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) 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.

About the study

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

What is being tested

Sponsor: Biohaven Therapeutics Ltd. · Participants: 300 · Started: Jun 26, 2026

Contact the study team

Official record on ClinicalTrials.gov — NCT07661056

Locations in the U.S.

ArizonaSite-044, Tucson
CaliforniaSite-032, Burbank
Site-062, Huntington Beach
Site-048, Oakland
Site-006, San Diego
Site-067, Walnut Creek
FloridaSite-052, Doral
Site-066, Fort Myers
Site-019, Hialeah
Site-027, Hollywood
Site-061, Miami
Site-059, Palm Beach Gardens
Site-074, Tampa
GeorgiaSite-029, Atlanta
Site-053, Fayetteville
IllinoisSite-031, Champaign
Site-080, Springfield
KansasSite-025, Lenexa
LouisianaSite-070, Baton Rouge
MichiganSite-046, Farmington Hills
MissouriSite-004, Kansas City
Site-015, St Louis
NevadaSite-072, Las Vegas
North CarolinaSite-038, Asheville
Site-011, Greenville
Site-063, Morehead City
Site-064, Morehead City
Site-039, Raleigh
Site-033, Statesville
Site-045, Wilmington
OhioSite-008, Canton
OklahomaSite-037, Norman
South CarolinaSite-010, North Charleston
TennesseeSite-016, Chattanooga
Site-017, Memphis
TexasSite-081, Amarillo
Site-020, Dallas
Site-055, Dallas
Site-043, Denton
Site-042, El Paso
Site-034, Houston
Site-071, Houston
Site-054, McKinney
Site-057, San Antonio
Site-036, Shavano Park
Site-009, Weslaco
UtahSite-013, Layton
VirginiaSite-073, Midlothian
WashingtonSite-076, Seattle

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.