Study of BHV-1300 in Graves' Disease
An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
1 other identifier
interventional
15
2 countries
17
Brief Summary
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Aug 2025
Typical duration for phase_1
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2025
CompletedFirst Posted
Study publicly available on registry
May 20, 2025
CompletedStudy Start
First participant enrolled
August 21, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2027
May 22, 2026
May 1, 2026
2 years
May 12, 2025
May 19, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks).
Baseline to Week 52
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
Baseline to Week 52
Study Arms (1)
BHV-1300
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- \. Participants must have serologically confirmed Graves' Disease.
You may not qualify if:
- History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit.
- History of treatment with radioactive iodine or thyroid surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (17)
Site-103
South Gate, California, 90280, United States
Site-100
Miami, Florida, 33126, United States
Site-104
Columbus, Georgia, 31904, United States
Site-108
Greenville, North Carolina, 27834, United States
Site-110
Canton, Ohio, 44718, United States
Site-107
Memphis, Tennessee, 38119, United States
Site-109
Dallas, Texas, 75246, United States
Site-106
Houston, Texas, 77054, United States
Site-101
Houston, Texas, 77095, United States
Site-105
Shavano Park, Texas, 78231, United States
Site-004
Fitzroy, 3065, Australia
Site-001
Kotara, 2289, Australia
Site-003
Melbourne, 3128, Australia
Site-010
Oaklands Park, 5046, Australia
Site-008
Parkville, 3050, Australia
Site-006
St Leonards, 2065, Australia
Site-002
Torquay, 3228, Australia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2025
First Posted
May 20, 2025
Study Start
August 21, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2027
Last Updated
May 22, 2026
Record last verified: 2026-05