BHV-1300: BHV-1300 is delivered subcutaneously (SC)
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria:
1\. Participants must have serologically confirmed Graves' Disease.
Key Exclusion Criteria:
1. 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.
2. History of treatment with radioactive iodine or thyroid surgery.
Primary outcome measure(s)
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths — Baseline to Week 52 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).
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities — Baseline to Week 52 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.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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