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
Biohaven Therapeutics Ltd.
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
Eligibility
- Age range
- 18–70 years
- Sex
- All
- Healthy volunteers
- No
Key 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 Key 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 evide…
Interventions
- DrugBHV-1300
delivered subcutaneously via autoinjector
- DrugPlacebo
delivered subcutaneously via autoinjector
Location
- Site-008Canton, Ohio