Graves Disease
Conditions
Keywords
Autoimmune thyroid disease, hyperthyroidism, anti thyroid drug, thyroid disease, autoimmune diseases, endocrine system diseases
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.
Interventions
DRUGBHV-1300
BHV-1300 is delivered subcutaneously (SC)
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia, United States
Contacts
CONTACTChief Medical Officer
Outcome results
None listed