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BHV-1300 · 2 trials · 1 indication
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).
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.
| Arm | Type | Description |
|---|---|---|
| BHV-1300 | EXPERIMENTAL | BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. |
| Placebo | PLACEBO_COMPARATOR | Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. |
| Name | Type | Description |
|---|---|---|
| BHV-1300 | DRUG | delivered subcutaneously via autoinjector |
| Placebo | DRUG | delivered subcutaneously via autoinjector |
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' Diseas...
BHV-1300 is an investigational small molecule being developed by Biohaven Ltd. for the treatment of Graves' Disease, an autoimmune endocrine condition. It is being studied in adults 18 years and older. BHV-1300 has not been approved by the FDA and remains in clinical development.
BHV-1300 targets IgG, a class of antibodies involved in autoimmune responses. By targeting IgG, BHV-1300 is designed to reduce the antibody-mediated processes that drive Graves' Disease. It is a small molecule therapeutic being developed by Biohaven Ltd. (ticker: BHVN).
BHV-1300 is being developed by Biohaven Ltd., which trades under the ticker BHVN. The company is advancing the small molecule in clinical trials for Graves' Disease, with two active studies currently recruiting participants.
BHV-1300 is in Phase 3 clinical development for Graves' Disease. Biohaven Ltd. is conducting a Phase 3 trial alongside a Phase 1 study. BHV-1300 is investigational and has not received FDA approval.
BHV-1300 is being evaluated in two recruiting clinical trials for Graves' Disease. The Phase 3 trial NCT07661056 is enrolling 300 adults across the United States, Canada, and Puerto Rico. The Phase 1 trial NCT06980649 is enrolling 15 adults in the United States and Australia. Both are randomized, double-blind, and placebo-controlled.