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

Purpose

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

Condition

  • Graves Disease

Eligibility

Eligible Ages
Between 18 Years and 70 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Drug: BHV-1300
    delivered subcutaneously via autoinjector
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.
  • Drug: Placebo
    delivered subcutaneously via autoinjector

Recruiting Locations

Site-032
Burbank, California 91501

Site-062
Huntington Beach, California 92647

Site-006
San Diego, California 92108

Site-067
Walnut Creek, California 94598

Site-052
Doral, Florida 33172

Site-019
Hialeah, Florida 33016

Site-031
Champaign, Illinois 61822

Site-025
Lenexa, Kansas 66234

Site-046
Farmington Hills, Michigan 48334

Site-072
Las Vegas, Nevada 89148

Site-038
Asheville, North Carolina 28803

Site-011
Greenville, North Carolina 27834

Site-063
Morehead City, North Carolina 28557

Site-064
Morehead City, North Carolina 28557

Site-039
Raleigh, North Carolina 27612

Site-033
Statesville, North Carolina 28625

Site-045
Wilmington, North Carolina 28405

Site-008
Canton, Ohio 44718

Site-016
Chattanooga, Tennessee 37411

Site-055
Dallas, Texas 75231

Site-020
Dallas, Texas 75246

Site-043
Denton, Texas 76210

Site-042
El Paso, Texas 79935

Site-071
Houston, Texas 77058

Site-054
McKinney, Texas 75069

Site-057
San Antonio, Texas 78251

Site-036
Shavano Park, Texas 78231

Site-013
Layton, Utah 84041

Site-073
Midlothian, Virginia 23112

Site-076
Seattle, Washington 98104

More Details

Status
Recruiting
Sponsor
Biohaven Therapeutics Ltd.

Study Contact

Chief Medical Officer
203-404-0410
clinicaltrials@biohavenpharma.com