Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease
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
2 other identifiers
interventional
300
1 country
24
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jun 2026
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 16, 2026
CompletedFirst Posted
Study publicly available on registry
June 22, 2026
CompletedStudy Start
First participant enrolled
June 26, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
February 1, 2028
July 30, 2026
July 1, 2026
1.5 years
June 16, 2026
July 29, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
Week 26
Secondary Outcomes (12)
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.
Week 26
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6
Baseline to Week 6
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26
Baseline to Week 26
Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26
Week 26
Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo
Up to 26 weeks
- +7 more secondary outcomes
Study Arms (2)
BHV-1300
EXPERIMENTALBHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Placebo
PLACEBO COMPARATORMatching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Interventions
Eligibility Criteria
You may qualify if:
- Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- Participants must have active hyperthyroidism due to Graves' disease
You may not qualify if:
- History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
- History of treatment with radioactive iodine or thyroid surgery.
- Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit.
- 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.
- Have autoimmune disease other than Graves' disease requiring treatment
- 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.
- Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (24)
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 16, 2026
First Posted
June 22, 2026
Study Start
June 26, 2026
Primary Completion (Estimated)
January 1, 2028
Study Completion (Estimated)
February 1, 2028
Last Updated
July 30, 2026
Record last verified: 2026-07